GxP • Quality • Regulatory • Operational Audits

From requirements to evidence-backed reports.

A1 Audit is an offline-first mobile audit companion that keeps the audit journey connected—from the applicable source and selected scope to evidence, reports and follow-up.

Regulatory • Quality • Operational Audits

See the complete audit journey Find the guide you need

Use A1 Audit with applicable regulations, standards, internal SOPs, supplier requirements and custom questionnaires.

The core app flow

One workflow, connected from source to follow-up

Choose a stage to open the exact screen instructions. The detailed workflow is explained once and linked wherever it is relevant.

1SourceRegulation Library 2Select scopeAudit Detail → Preparation 3ConductStart your audit 4EvidenceNotes, findings and proof 5ReportDraft and Final DOCX 6Follow upAudit Dashboard Reports

Use your applicable requirement

One method for regulations, standards and internal requirements

You choose the current source and the questions that apply. A1 Audit supports the same audit method whether the source is GMP, GDP, GLP, HACCP, ANVISA-based, an internal SOP, a supplier standard or a custom questionnaire.

GMP GDP GLP HACCP ANVISA-based Internal SOPs Supplier Custom

See it working end to end

Follow one audit from the Library to a Final DOCX and trend dashboard.

The Harbour Table Café example shows exact screen routes, question selection, evidence, report control, Windows continuation and follow-up without repeating the operating manual.

Regulation Library → Audit Detail → Conduct → Reporting → Audit Dashboard Reports

Visual, practical and based on the real app flowOpen the complete example

Exact screen instructions

What do you need to do in A1 Audit?

Choose the part of the audit journey you are working on. Each item opens the exact guide for that task.

Prepare your audit

Set up access, create the audit and select the applicable questions.

Set up your passkeyCreate or reuse the correct A1 Audit identity. Use the DashboardFind your audits and the main app routes. Create an auditEnter the audit details and participants. Open the Regulation LibraryWork with regulations, SOPs and questionnaires. Select your questionsBuild the scope for this specific audit.

Conduct and document

Work through the questions and keep the evidence connected.

Conduct the auditStart the selected audit and move through the scope. Use Checklist ModeReview and complete questions efficiently. Record findings and evidenceAdd notes, findings, photos and references. Capture document details with OCRRead controlled-document information from the camera.

Report, move and manage

Create the report, continue on Windows and control the app.

Create Draft and Final ReportsReview report content and generate the DOCX. Export, import and Smart MergeMove audit work securely between devices. Adjust settings and controlsManage display, security and app preferences. Review audit trendsUse Audit Dashboard Reports for recurring insights.

Mobile companion, professional responsibility

A1 Audit supports the work—it does not make the audit decision.

You remain responsible for applicable requirements, scope, evidence assessment, findings, conclusions, report review, the device, login identity and backups.

Understand data and responsibility

Searchable regulatory and audit terminology

Regulations, chapters, audit topics and abbreviations

This expandable reference index groups real terminology from the A1 Audit Oracle source libraries with common GxP and audit terms. Open only the source you need or search the index. A1 Audit does not determine applicability and is not endorsed by the listed authorities.

Search this terminology index

Abbreviations and full termsGxP, authorities, systems, qualification, validation, food safety and quality terminology132 terms

3PL: Third-party logistics provider
ALCOA: Attributable, Legible, Contemporaneous, Original and Accurate
ALCOA+: ALCOA plus Complete, Consistent, Enduring and Available
ANVISA: Agência Nacional de Vigilância Sanitária; Brazilian Health Regulatory Agency
API: Active Pharmaceutical Ingredient
APQR: Annual Product Quality Review
APR: Annual Product Review
APR/PQR: Annual Product Review / Product Quality Review
APS: Aseptic Process Simulation
BFS: Blow-Fill-Seal
BMR: Batch Manufacturing Record
CAC: Codex Alimentarius Commission
CAPA: Corrective and Preventive Action
CCP: Critical Control Point
CCS: Contamination Control Strategy
CDSCO: Central Drugs Standard Control Organisation, India
CFR: Code of Federal Regulations
cGMP: Current Good Manufacturing Practice
CIP: Clean-in-Place
CLO: Contract Laboratory Organisation
CMO: Contract Manufacturing Organisation
CoA: Certificate of Analysis
COTS: Commercial Off-the-Shelf
CPP: Critical Process Parameter
CPV: Continued Process Verification
CQA: Critical Quality Attribute
CSV: Computerised System Validation
CTA: Clinical Trial Authorisation
CXC: Codex Alimentarius code-of-practice identifier
DQ: Design Qualification
EC: European Commission or European Community, depending on the legal reference
eCFR: Electronic Code of Federal Regulations
EEA: European Economic Area
EM: Environmental Monitoring
EMA: European Medicines Agency
ERP: Enterprise Resource Planning
EU: European Union
EU GDP: European Union Good Distribution Practice
EU GMP: European Union Good Manufacturing Practice
EU/EEA: European Union / European Economic Area
FAT: Factory Acceptance Test
FDA / US FDA: United States Food and Drug Administration
FDS: Functional Design Specification
FEFO: First Expired, First Out
FFS: Form-Fill-Seal
FIFO: First In, First Out
G.S.R.: General Statutory Rules; Indian Gazette notification designation
GAMP: Good Automated Manufacturing Practice
GCP: Good Clinical Practice
GDocP: Good Documentation Practice; sometimes informally called GDP, but GDocP avoids confusion with Good Distribution Practice
GDP: Good Distribution Practice
GEP: Good Engineering Practice
GHP: Good Hygiene Practices
GLP: Good Laboratory Practice
GMP: Good Manufacturing Practice; “practice” is the noun used in the official term
GMP/GDP: Good Manufacturing Practice and Good Distribution Practice
GSP: Good Storage Practice
GVP / GPvP: Good Pharmacovigilance Practices
GWP: Good Warehousing Practice
GxP: Good x Practice; umbrella term for regulated good-practice requirements
HACCP: Hazard Analysis and Critical Control Point
HBEL: Health-Based Exposure Limit
HEPA: High-Efficiency Particulate Air
HVAC: Heating, Ventilation and Air Conditioning
ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
IMP: Investigational Medicinal Product
IOQ: Combined Installation and Operational Qualification
IPC: In-Process Control
IQ: Installation Qualification
IQ/OQ: Installation Qualification / Operational Qualification
IT: Information Technology
ITSM: Information Technology Service Management
KPI: Key Performance Indicator
LIMS: Laboratory Information Management System
LOD: Limit of Detection
LOQ: Limit of Quantitation
MA: Marketing Authorisation
MACO: Maximum Allowable Carryover
MAH: Marketing Authorisation Holder
MBR: Master Batch Record
MES: Manufacturing Execution System
MHLW: Ministry of Health, Labour and Welfare, Japan
MHRA: Medicines and Healthcare products Regulatory Agency, United Kingdom
MHRA Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors
MIA: Manufacturing and Import Authorisation
MRA: Mutual Recognition Agreement
MSPC: Multivariate Statistical Process Control
MTD: Maximum Tolerable Downtime
OJT: On-the-Job Training
OOS: Out of Specification
OOS/OOT: Out of Specification / Out of Trend
OOT: Out of Trend
OPRP: Operational Prerequisite Programme
OPV: Ongoing Process Verification
OQ: Operational Qualification
OTC: Over-the-Counter
PAT: Process Analytical Technology
PIC/S: Pharmaceutical Inspection Co-operation Scheme
PMDA: Pharmaceuticals and Medical Devices Agency, Japan
PMDA/MHLW: Pharmaceuticals and Medical Devices Agency / Ministry of Health, Labour and Welfare
PQ: Performance Qualification
PQR: Product Quality Review
PQR/APR: Product Quality Review / Annual Product Review
PQS: Pharmaceutical Quality System
PRP: Prerequisite Programme
PSF: Product Specification File
PV: Process Validation or Pharmacovigilance, depending on context
QA: Quality Assurance
QATA: Quality and Technical Agreement
QbD: Quality by Design
QC: Quality Control
QMS: Quality Management System
QP: Qualified Person
QRM: Quality Risk Management
RABS: Restricted Access Barrier System
RACI: Responsible, Accountable, Consulted and Informed
RCA: Root Cause Analysis
RDC: Resolução da Diretoria Colegiada; ANVISA Collegiate Board Resolution
RP: Responsible Person
SAT: Site Acceptance Test
SIP: Sterilise-in-Place
SLA: Service Level Agreement
SME: Subject-Matter Expert
SOP: Standard Operating Procedure
TOC: Total Organic Carbon
UK: United Kingdom
URS: User Requirements Specification
VMP: Validation Master Plan
WDA: Wholesale Distribution Authorisation
WHO: World Health Organization
WI: Work Instruction
WMS: Warehouse Management System

Audit types, activities and search terminologyInternal audits, self-inspections, supplier audits, regulatory inspections, evidence, findings and reports80 terms

Audit
GxP audit
GMP audit
GDP audit
GLP audit
HACCP audit
quality audit
regulatory audit
compliance audit
internal audit
internal quality audit
self-inspection
self inspection
self inspections
self-inspections
supplier audit
vendor audit
contract manufacturer audit
third-party audit
external audit
remote audit
on-site audit
system audit
process audit
product audit
facility audit
warehouse audit
distribution audit
transport audit
cold-chain audit
laboratory audit
data-integrity audit
computerised-system audit
validation audit
qualification audit
documentation audit
training-system audit
change-control audit
deviation audit
CAPA audit
complaint audit
recall audit
traceability audit
food-safety audit
hygiene audit
sanitation audit
allergen audit
pest-control audit
supplier-qualification audit
inspection readiness
mock inspection
regulatory inspection
gap assessment
readiness assessment
due diligence audit
quality-system review
risk-based audit
audit programme
audit plan
audit scope
audit checklist
audit question
objective evidence
audit evidence
audit observation
audit finding
critical finding
major finding
minor finding
opportunity for improvement
audit report
draft audit report
final audit report
audit trail
follow-up audit
finding closure
CAPA effectiveness check
management review
periodic review
continuous improvement

ANVISA GMP RDC 658/2022GMP · RDC 658/202210 chapter references · 199 topics

Chapter references and titles

Chapter IInitial Provisions
Chapter IIPharmaceutical Quality System
Chapter IIIPersonnel
Chapter IVFacilities and Equipment
Chapter VDocumentation
Chapter VIProduction
Chapter VIIQuality Control
Chapter VIIIOutsourced Activities
Chapter IXComplaints and Product Recall
Chapter XSelf-Inspection

Audit topics

Regulatory scope
Manufacturing applicability
Experimental medicines
Controlled terminology
Quality objective
Senior management accountability
PQS documentation
Quality resources
Lifecycle GMP
System complexity
Product and process knowledge
Production control specification
Supplier selection
Outsourced activity management
State of control
Deviation prevention
Change evaluation
Post-change verification
Root cause analysis
Human error justification
CAPA effectiveness
Ultimate PQS responsibility
Management review
Quality manual
GMP definition
Defined processes
Critical step validation
Personnel qualification
Storage and transport
Procedure clarity
Contemporaneous records
Batch traceability
Production responsibility
QC independence
Periodic quality review
PQR trend identification
PQR action management
MAH-manufacturer agreement
QRM process
Risk documentation proportionality
Qualified staffing
Responsibility records
Initial and ongoing GMP training
Practical experience
Resource allocation
Workload risk
Organizational chart
Job descriptions
No responsibility gaps
Role communication
Quality policy
Key personnel designation
Production-release independence
QC-production independence
Production duties
QC duties
Task-specific training
High-risk area training
Visitor supervision
Health condition reporting
Facility suitability
Error prevention design
Environmental location
Maintenance state
Cleaning disinfection
Environmental conditions
Pest protection
Unauthorized access
Passage control
Cross-contamination prevention
Logical flow
Orderly arrangement
Cleanable surfaces
Cleanable installations
Production ventilation
Weighing room
Dust control
Packaging facility design
Storage capacity
Sampling contamination control
Printed packaging security
QC laboratory separation
Equipment cleanability
Calibration records
Defective equipment
Documentation system
Good documentation practices
Data integrity controls
Hybrid system control
Document preparation
Authorized approval
Instructional language
Document review
Legible entries
Contemporaneous record completion
Record corrections
Batch document retention
Critical raw data retention
Specifications
Material specification content
Finished product specification content
Manufacturing formula
Yield limits
Line clearance instructions
Packaging instructions
Batch processing record
Receipt procedures
Release and rejection procedures
Distribution records
Equipment logbooks
Production procedures
Production supervision
Material handling procedures
Incoming material verification
Material status control
Storage conditions
Material dispensing
Material contamination prevention
Material segregation
Yield reconciliation
Process control
Status labeling
Area cleanliness
Deviation approval
Production access
Non-medicinal products
Contamination assessment
Technical and organizational controls
Toxicological assessment
Dedicated facilities decision
Cleaning validation
Containment controls
Prevention during processing
Validated process changes
Processing deviations
Packaging area clearance
Packaging segregation
Packaging reconciliation
Printed material control
Line clearance records
Clean containers
Labeling timing
Printing verification
Online packaging controls
Unusual packaging discrepancies
Finished product quarantine
Rejected material control
Exceptional reprocessing
Returned product assessment
Supply restriction notification
QC release controls
QC involvement
QC department
QC resources
QC procedure ownership
Finished product evaluation
QC access to production
Microbiology lab contamination control
QC documents availability
Trend analysis
Sampling procedure
Representative samples
Sampling plan justification
Validated analytical methods
Method transfer suitability
Approved test methods
CQA trend consistency
Test record content
Reagent control
Culture media performance
Ongoing stability
Stability protocol content
Stability OOS/OOT
Analytical transfer readiness
Outsourced activity control
Written contract
Release authority
Outsourcing compliance
Outsourced activity review
Contractor qualification
Records assessment
Contracted company capability
Subcontracting approval
Right to audit
Complaint system
QRM in defects
Authority notification
Complaint investigation competence
Complaint procedure
Deviation investigation scope
Root cause in defects
CAPA from defects
Recall records availability
Recall system effectiveness
Self-inspection program
Self-inspection scope
Independent inspectors
Self-inspection records
Corrective measures

EU Guidelines on Good Distribution Practice of medicinal products for human useGDP · 2013/C 343/0110 chapter references · 100 topics

Chapter references and titles

CHAPTER 1Quality Management
CHAPTER 2Personnel
CHAPTER 3Premises and Equipment
CHAPTER 4Documentation
CHAPTER 5Operations
CHAPTER 6Complaints, Returns, Suspected Falsified Medicinal Products and Recalls
CHAPTER 7Outsourced Activities
CHAPTER 8Self-Inspections
CHAPTER 9Transportation
CHAPTER 10Specific Provisions for Brokers

Audit topics

Pharmaceutical Quality System
Quality Risk Management
Management Review
Deviation and CAPA Oversight
Change Control
Outsourced GDP Process Oversight
Quality Metrics
Product Quality Protection
Regulatory Compliance Oversight
GDP Knowledge Management
Data Integrity in GDP Records
Continuous Improvement
Responsible Person
RP Absence and Delegation
Personnel Qualification
Training Program
Hygiene and Safety
Organisational Structure
Contractors and Consultants
Job Descriptions
Staffing Levels
Escalation Awareness
Premises Suitability
Temperature-Controlled Storage
Monitoring Equipment
Access Control
Segregation Areas
Cleaning and Pest Control
Maintenance
Computerised Systems
Alarm Management
Receiving and Dispatch Areas
Waste and Damaged Goods
Utilities and Power
Document Control
Record Completeness
Record Corrections
Procedural Detail
Electronic Records
Transaction Records
Controlled Forms
Retention and Retrieval
Supplier Qualification
Customer Qualification
Receipt of Products
Inbound Temperature Checks
Storage Status Control
Picking and Packing
Dispatch Release
Stock Rotation
Inventory Reconciliation
Product Damage Handling
Product Traceability
Falsified Medicines Prevention
Product Sourcing
Product Supply
Special Storage Requirements
Restricted Products
Returns Decision Flow
Cross-Border Supply
Complaint Handling
Product Quality Complaints
Returned Goods Procedure
Return to Saleable Stock
Suspected Falsified Products
Recall Procedure
Recall Execution
Recall Communication
Returned Product Destruction
Complaint Trend Review
Temperature Excursion Complaints
Market Action Interface
Quarantine During Investigation
Effectiveness Checks
Contract Acceptor Qualification
Written Contract
Contract Giver Oversight
Subcontracting Control
Outsourced Record Access
Service Provider Change Control
Self-Inspection Program
Audit Scope Coverage
Auditor Competence
CAPA from Self-Inspection
Trend of Findings
Inspection Readiness
Transport Control Strategy
Carrier Qualification
Transport Temperature Management
Route Risk Assessment
Vehicle Suitability
Transport Handover
In-Transit Deviation Handling
Transport Security
Transport Documentation
Temporary Storage in Transit
Delivery Failure
Transport Performance Review
Broker Registration
Broker Records

EU GMP Annex 11 — Computerised SystemsGMP · Revision January 2011; coming into operation 30 June 201118 chapter references · 18 topics

Chapter references and titles

A11-PPrinciple
A11-1Risk Management
A11-2Personnel
A11-3Suppliers and Service Providers
A11-4Validation
A11-5Data
A11-6Accuracy Checks
A11-7Data Storage
A11-8Printouts
A11-9Audit Trails
A11-10Change and Configuration Management
A11-11Periodic Evaluation
A11-12Security
A11-13Incident Management
A11-14Electronic Signature
A11-15Batch Release
A11-16Business Continuity
A11-17Archiving

Audit topics

Computerised systems principle
Lifecycle risk management
Personnel, roles and cooperation
Supplier and service provider control
Validation project and lifecycle control
Data controls
Accuracy checks
Data storage and protection
Printouts and record review
Audit trails
Change and configuration management
Periodic evaluation
Security and access control
Incident management
Electronic signature controls
Batch release controls
Business continuity
Archiving

EU GMP Annex 15 - Qualification and ValidationGMP · Revision 30 March 2015; in operation 1 October 201513 chapter references · 131 topics

Chapter references and titles

Principle
General
1Organising and Planning
2Documentation, including VMP
3Qualification Stages
4Re-qualification
5Process Validation
6Verification of Transportation
7Validation of Packaging
8Qualification of Utilities
9Validation of Test Methods
10Cleaning Validation
11Change Control

Audit topics

Validated lifecycle control
Quality risk management
Retrospective validation
External data reliance
Lifecycle planning
Trained validation personnel
Quality oversight
Validation master plan
VMP content - policy
VMP roles and responsibilities
VMP validation status overview
VMP change/deviation controls
VMP acceptance criteria guidance
VMP document references
VMP requalification strategy
Complex project validation planning
Risk assessment repetition
Data integrity checks
Good documentation practice
Approval of validation documents
Document interrelationship
Validation protocol content
Combined qualification documents
Third-party protocols
Protocol changes during execution
Failed acceptance criteria
Validation report conclusions
Stage-gate release
Qualification lifecycle stages
URS quality requirements
URS lifecycle reference
Design qualification
FAT evaluation
Pre-installation URS compliance
Avoiding unnecessary test repetition
Site acceptance testing
Installation qualification performance
IQ installation verification
IQ supplier instructions and maintenance
IQ calibration
IQ materials of construction
OQ sequence
OQ design operation tests
OQ operating limits
OQ completion outputs
PQ sequence
PQ materials and batch sizes
PQ operating range
Periodic control evaluation
Requalification criteria
PV applicability
Regulatory/GMP lifecycle link
PV approach robustness
Prospective validation expectation
Strength/site coverage
Transfer bracketing
Legacy product transfer
CPP/CQA identification
Commercial batch size
Qualified equipment and validated methods
Accessible process knowledge
Trained production personnel
Critical supplier qualification
Design space/model knowledge
Market release of validation batches
IMP reference
Concurrent validation justification
Concurrent validation QP availability
Traditional routine conditions
PV batch number justification
Three-batch expectation
PV protocol CPP/CQA
PV protocol process description
PV protocol responsibilities
PV protocol CQA summary
PV protocol CPP limits
PV protocol non-critical monitoring
PV protocol equipment and calibration
PV protocol analytical methods
PV protocol IPCs
PV protocol additional testing
PV protocol sampling plan
PV protocol result evaluation
PV protocol release/certification
Continuous verification conditions
CPV method and control strategy
CPV batch justification
CPV general principles
Hybrid validation approach
Hybrid after changes
OPV applicability
Product quality monitoring
OPV frequency review
OPV protocol and statistics
PQR and incremental changes
Transport conditions
Transport routes and seasonality
Transport risk assessment
Critical condition monitoring
Packaging equipment qualification
Packaging operating ranges
Utility quality confirmation
Seasonal utility qualification
Direct/indirect utility contact
Analytical method validation
Microbial product method recovery
Cleanroom surface recovery
Cleaning effectiveness
Visual cleanliness limitation
Cleaning verification during programme
Automated cleaning validation
Cleaning variables and worst case
HBEL/toxicological residue limits
Macromolecule exception
Representative residue parameters
Microbial/endotoxin risks
Dirty and clean hold times
Campaign length
Worst-case product selection
Sampling locations
Sampling method recovery
Cleaning procedure repetitions
Ineffective cleaning controls
Manual cleaning frequency
Change control in PQS
Written procedures for lifecycle changes
Design space changes
QRM impact evaluation
Change authorisation
Supporting data before approval
Post-implementation effectiveness

EU GMP Annex 16 — Certification by a Qualified Person and Batch ReleaseGMP · Revision October 2015; in operation 15 April 201645 chapter references · 90 topics

Chapter references and titles

A16-GPScope and General Principles
1.11. The Process of Certification
1.21. The Process of Certification
1.31. The Process of Certification
1.41. The Process of Certification
1.4.11. The Process of Certification
1.4.21. The Process of Certification
1.4.31. The Process of Certification
1.51. The Process of Certification
1.5.11. The Process of Certification
1.5.31. The Process of Certification
1.5.41. The Process of Certification
1.5.51. The Process of Certification
1.5.61. The Process of Certification
1.71. The Process of Certification
1.7.31. The Process of Certification
1.7.41. The Process of Certification
1.7.51. The Process of Certification
1.7.61. The Process of Certification
1.7.71. The Process of Certification
1.7.111. The Process of Certification
1.7.121. The Process of Certification
1.7.131. The Process of Certification
1.7.141. The Process of Certification
1.7.151. The Process of Certification
1.7.161. The Process of Certification
1.7.171. The Process of Certification
1.7.181. The Process of Certification
1.7.191. The Process of Certification
1.7.201. The Process of Certification
1.7.211. The Process of Certification
1.81. The Process of Certification
1.91. The Process of Certification
1.101. The Process of Certification
2.12. Relying on GMP Assessments by Third Parties
3.03. Handling of Unexpected Deviations
3.13. Handling of Unexpected Deviations
3.1(i)3. Handling of Unexpected Deviations
3.1(ii)3. Handling of Unexpected Deviations
3.1(iii)3. Handling of Unexpected Deviations
4.14. The Release of a Batch
4.24. The Release of a Batch
4.34. The Release of a Batch
Appendix IAppendices I and II
Appendix IIAppendices I and II

Audit topics

Scope
General principles
Certification eligibility
Pre-release control
QP product knowledge
QP competence boundaries
Complex supply chain oversight
Manufacturing step completeness
EU manufacturing QP confirmation
Partial operation accountability
MA access for confirming QP
Shared QP responsibility
Different MIA holder reliance
Deviation responsibility split
Formal agreement between QPs
Imported batch certification
Supply chain complexity control
Transport and sample conditions
EU retesting requirement
Finished product quality checks
Imported batch sampling approach
Third-country sample risk control
Supply chain diagram
Subcontractor critical steps
Audit report availability
MA site compliance
Activity consistency with MA
Starting material compliance
Packaging material compliance
API GMP evidence
Blood/plasma compliance
New or changed sites
Validation status
Ongoing stability implications
PQR/APR signals
Deviation and change status
Complaint and recall trend awareness
Technical agreements
Self-inspection currency
Distribution and shipment arrangements
Safety features
Unexpected deviation escalation
Parallel importation
Repackaging GMP control
QP certification register
Register retention and availability
Outsourced assessment control
Third-party audit scope
Auditor qualification
Audit report access
Third-party audit independence
Critical outsourced activities
CAPA reliance limits
Frequency of reliance review
Audit report redaction risk
Multi-client audit limitations
Outsourced activity agreement
Regulatory inspection signals
Unexpected deviation policy
Deviation root cause correction
Variation need assessment
QRM methodology
Negligible impact conclusion
Safety efficacy impact
Stability programme inclusion
Biological product sensitivity
Shared QP deviation awareness
Deviation timing control
Minor deviation accumulation
Analytical deviation interface
Deviations from approved control methods
QP certification with open CAPA
Post-certification discovery
Deviation communication across parties
Quarantine before certification
Approved quarantine shipment
Premature release safeguards
Manual override governance
Inter-site transfer safeguards
Formal QP notification
Technical agreement notification terms
Chapter 4 documentation control
Saleable stock reconciliation
Release communication failure
Confirmation content
Confirmation statement integrity
Technical agreement reference
Batch certificate content
Destination country accuracy
Certificate statement control

EU GMP Annex 1 - Manufacture of Sterile Medicinal ProductsGMP · 2022 revision; fully applicable 2024-08-2510 chapter references · 200 topics

Chapter references and titles

Annex 1 Section 1Scope
Annex 1 Section 2Principle
Annex 1 Section 3Pharmaceutical Quality System
Annex 1 Section 4Premises
Annex 1 Section 5Equipment
Annex 1 Section 6Utilities
Annex 1 Section 7Personnel
Annex 1 Section 8Production and Specific Technologies
Annex 1 Section 9Environmental and Process Monitoring
Annex 1 Section 10Quality Control

Audit topics

Annex 1 applicability to sterile dosage forms
Inclusion of terminal sterilisation and aseptic processing
Use of Annex 1 principles beyond sterile manufacturing
Interface with Part I and applicable annexes
Scope boundaries for non-sterile support areas
Sterility assurance ownership across the lifecycle
Sterility assurance strategy
Contamination prevention mindset
Integration of microbiological, particulate and pyrogen controls
Scientific justification of controls
Routine confirmation of control state
Operator behaviour as a contamination source
Quality oversight of sterile operations
Holistic evaluation before batch release
Contamination Control Strategy ownership
CCS content completeness
CCS linkage to risk management
CCS lifecycle review
Management review of sterility assurance
Quality risk management quality
Deviation escalation for sterile operations
CAPA effectiveness for contamination events
Change control impact on sterility assurance
Supplier qualification for sterile-critical materials
Process performance and product quality monitoring
Knowledge management for sterile processes
Data integrity in sterile manufacturing records
Sterility assurance training governance
Qualification of critical staff
Handling of recurring observations
PQS controls for outsourced sterile activities
Quality oversight during shutdown and restart
Batch release sterility assurance package
Contamination event investigation depth
Periodic CCS effectiveness review
Governance of residual risks
Cleanroom classification strategy
Cleanroom layout and process flow
Grade A critical zone protection
Grade B background controls
Airlock design and use
Pressure cascade and airflow direction
Airflow visualisation studies
Facility qualification lifecycle
Facility maintenance in sterile areas
Surface finish suitability
Cleaning and disinfection programme
Disinfectant qualification
Cleanroom cleaning verification
Cleanroom access control
Personnel changing rooms
Material transfer controls
Waste removal controls
Cleanroom occupancy control
HVAC alarm management
Campaign and room readiness checks
Facility segregation for contamination risks
Drain and sink restrictions
Cleanroom repair management
Equipment design for sterile operations
Equipment qualification status
Preventive maintenance controls
Calibration of critical instruments
Equipment cleaning controls
Equipment sterilisation controls
Aseptic assembly controls
Equipment alarms and interlocks
Single-use system control
Equipment status management
Line clearance for sterile equipment
Equipment integrity after intervention
Equipment change control
Water system design for sterile manufacturing
Water system monitoring
Clean steam quality
Compressed gas quality
Process vacuum controls
HVAC utility lifecycle
Utility alarm response
Utility maintenance impact
Utility sampling points
Water hold and distribution control
Sterile gas filtration
Utility trending
Utility qualification after change
Backflow prevention
Power failure resilience
Utility contamination investigation
Sampling technique training
Utility data integrity
Aseptic personnel qualification
Gowning qualification programme
Operator behaviour in cleanrooms
Training for contamination control strategy
Cleanroom access restriction
Health and hygiene controls
Requalification after absence or failure
Training for engineering and cleaning staff
QA and supervisory oversight
Media fill participation rules
Manual intervention qualification
Personnel monitoring programme
Cleanroom discipline culture
Contractor control
Shift handover for sterile operations
Training effectiveness checks
Aseptic process design
Terminal sterilisation preference
Sterilisation cycle validation
Load pattern control
Sterile filtration strategy
Pre-use post-sterilisation integrity testing
Post-use filter integrity testing
Bioburden control before sterilisation
Endotoxin control
Component preparation
Container closure preparation
Aseptic filling setup
Routine interventions
Non-routine interventions
Line stoppages
Filling duration limits
Sterile product hold times
Aseptic process simulation design
Media fill acceptance criteria
Media fill incubation and inspection
Media fill failure investigation
RABS operation
Isolator operation
Isolator decontamination validation
Glove integrity management
Rapid transfer ports
Freeze-drying operations
Lyophiliser loading interventions
Blow-fill-seal controls
Form-fill-seal or closed systems
Closed processing justification
Single-use assemblies in production
Sterile connections
In-process sampling
Environmental conditions during setup
Sterile area line clearance
Reconciliation of sterile components
Visual inspection process
Container closure integrity
Crimping and capping controls
Sterilisation by dry heat
Sterilisation by moist heat
Sterilisation by radiation
Sterilisation by gas or vapour
Sterile filtration process parameters
Redundant filtration arrangements
Product transfer after sterilisation
Aseptic additions
Process simulation for campaign worst case
Intervention frequency trending
Environmental monitoring programme design
Grade A viable monitoring
Non-viable particle monitoring
EM location justification
Alert and action limits
EM excursion investigation
Microbial identification strategy
Personnel monitoring timing
Settle plate exposure control
Active air sampling controls
Surface monitoring controls
Monitoring during interventions
Process monitoring linkage to batch release
EM data trending
Adverse trend escalation
Incubation conditions
Media and plate controls
EM method suitability
EM after cleaning/disinfection
Monitoring of isolators or RABS
Rapid microbiological methods
Continuous particle monitoring alarms
EM sample reconciliation
Cleanroom qualification monitoring
Operator feedback from monitoring
Monitoring during aseptic process simulation
Contamination recovery after excursion
Batch impact of EM results after release
Sterility test governance
Sterility test limitations understanding
Bioburden testing
Bacterial endotoxin testing
Environmental monitoring laboratory controls
QC investigation of contamination
Growth promotion testing
Microbial identification capability
QC data integrity
Sample transport controls
Laboratory contamination control
Invalid test criteria
Rapid or alternative microbiological methods
QC trend reporting to PQS
Reference culture control
Laboratory method lifecycle

EU GMP Annex 21 - Importation of Medicinal ProductsGMP · Annex 21; published 16 February 2022; in operation 21 August 202210 chapter references · 100 topics

Chapter references and titles

1Scope and applicability
2Principle
3Pharmaceutical Quality System
4Premises and Equipment
5Documentation
6Operations
7QP certification interface
8Outsourced activities
9Supply chain and transport
10Defects, recalls, returns and continuous improvement

Audit topics

Import model
Product scope
EU/EEA border crossing
MIA holder coverage
Third-country source clarity
Direct re-export exclusion
IMP importation
Import responsibility matrix
Importation principles
EU/EEA QP oversight
Import site control
Release prevention
EU GMP integration
Import compliance governance
Regulatory alignment
Import quality risk management
PQS ownership
Procedure set
Import process map
Quality agreements
Supplier qualification
Audit reliance
Change control
Deviation management
CAPA effectiveness
Training
Data governance
Periodic review
Quality defects
Product quality review input
QP access to PQS data
Import premises suitability
Quarantine areas
Temperature-controlled storage
Receipt equipment
Sampling facilities
Security
Damaged shipment area
Computerised systems
Transport handover areas
Calibration and monitoring
Import documentation package
Batch traceability
Manufacturing records access
Analytical records
Transport records
Customs documentation
Certificate checks
Record retention
Language and translation
Document discrepancies
Electronic data transfer
Site and route master data
Import SOP effectiveness
Technical agreements content
Periodic documentation review
Pre-import readiness
Shipment approval
Receipt checks
Quantity reconciliation
Status labelling
Tamper evidence
Temperature data review
Sampling control
Testing strategy
EU/EEA testing site
MRA reliance
Batch blocking
Transfer before certification
Imported returns
Rejected imported goods
QP certification readiness
QP independence
Batch release evidence
QP confirmation from other sites
Multiple QP responsibilities
Unexpected deviations
MA compliance check
Clinical trial release check
QP batch file review
Certification register
Certification after transfer
Contract manufacturer control
Contract laboratory control
Logistics provider control
Customs broker control
Subcontracting visibility
Agreement review frequency
MAH or sponsor interface
Service provider deviations
Route qualification
Temperature excursion response
Shipment security
Delay management
Cold-chain packout
Chain of custody
Complaint linkage
Recall readiness
Quality defect notification
Destruction control

EU GMP Part I – Basic Requirements for Medicinal ProductsGMP · EudraLex Volume 4 Part I Chapters 1–9; current European Commission page checked 2026-06-119 chapter references · 200 topics

Chapter references and titles

CHAPTER 1Pharmaceutical Quality System
CHAPTER 2Personnel
CHAPTER 3Premises and Equipment
CHAPTER 4Documentation
CHAPTER 5Production
CHAPTER 6Quality Control
CHAPTER 7Outsourced Activities
CHAPTER 8Complaints and Product Recall
CHAPTER 9Self Inspection

Audit topics

PQS governance
Management responsibility
Quality objectives
Quality risk management
Knowledge management
Product quality review
Process performance monitoring
Deviation management
CAPA system
Change control
Supplier qualification
Material lifecycle control
Batch disposition governance
Quality culture
Data integrity governance
Computerised system oversight
Validation lifecycle governance
Regulatory compliance review
Out-of-specification governance
Complaint trend linkage
Recall readiness governance
Quality agreement governance
Training system effectiveness
Resource adequacy
Environmental control governance
Lifecycle document control
Quality metrics integrity
Internal audit programme
Escalation of critical issues
Periodic effectiveness review
Site master file accuracy
Hybrid GMP/GDP interfaces
Regulatory inspection readiness
Quality defect decision process
Continuous improvement
Organisation chart
Key personnel
Qualified Person availability
Training matrix
Task qualification
GMP induction
Continued training
Training effectiveness
Consultants and contractors
Hygiene programmes
Health restrictions
Behaviour in production areas
Job descriptions
Delegation control
Personnel adequacy
Access by training status
Quality unit independence
Line management responsibilities
Personnel records
Continuous competence
Facility design
Area segregation
Cleanability
Maintenance programme
Qualification status
Utilities
Environmental monitoring
Pest control
Lighting and ventilation
Equipment calibration
Defective equipment
Computerised equipment
Storage areas
Weighing and dispensing areas
Sampling facilities
Production equipment design
Equipment logbooks
Waste management
Premises change control
Housekeeping
Document hierarchy
Document approval
Document revision control
Good documentation practices
Record creation
Batch record design
Batch record review
Specification control
Manufacturing formula
Packaging instructions
Procedure clarity
Data retention
Electronic records
Hybrid records
Logbooks
Raw data
Record corrections
Document distribution
Critical forms
SOP training linkage
Translations
Quality records indexing
Certificate and report control
Review by exception
Documented rationale
Production instructions
Line clearance
Material identity
Weighing control
Prevention of contamination
Cross-contamination control
Cleaning validation
Cleaning status control
In-process controls
Yield and reconciliation
Processing deviations
Process parameter control
Equipment setup
Batch numbering
Intermediate and bulk control
Hold time control
Packaging component control
Packaging line controls
Coding and overprinting
Rework control
Rejected material handling
Recovered materials
Returned product manufacturing impact
Prevention of unauthorised access
Production scheduling
Process validation linkage
Aseptic or sterile interface exclusion
Temperature-sensitive production stages
Metal and foreign matter control
Tooling and format parts
Process alarms
Campaign manufacturing
Material transfer
Production data review
Shopfloor oversight
QC independence
Laboratory facilities
Sampling programme
Sample receipt
Testing methods
Specifications in QC
Instrument qualification
Reference standards
OOS investigations
OOT and atypical trends
Raw data review
LIMS controls
Microbiological testing
Stability programme
Retest and expiry
Contract laboratories
Certificate of analysis
Sampling of packaging materials
Environmental monitoring lab data
Lab deviations
Analyst qualification
Lab housekeeping
Result reporting timelines
Data transcription
QC retain samples
Outsourcing governance
Technical agreement
Contract giver oversight
Contract acceptor capability
Subcontracting control
Change notification
Deviation reporting
Data access
Audit programme
Performance review
Regulatory inspection support
Technology transfer
Returned documentation
QP information flow
Termination or transfer
Complaint intake
Complaint investigation
Defect classification
Recall decision process
Recall execution
Authority notification
Mock recall
Complaint trend review
Returned complaint samples
Falsified or tampered product
Complaint CAPA
Recall contact data
Recall closure
Complaint record retention
Interface with pharmacovigilance
Self-inspection programme
Auditor independence
Inspection depth
Finding classification
CAPA follow-up
Management review input
Regulatory observation linkage
Outsourced areas
Report quality
Programme effectiveness

EU GMP Part II – Basic Requirements for Active Substances used as Starting MaterialsGMP · EudraLex Volume 4 Part II; Basic requirements for active substances used as starting materials (August 2014); current European Commission page checked 2026-06-1118 chapter references · 200 topics

Chapter references and titles

SECTION 2Quality Management
SECTION 3Personnel
SECTION 4Buildings and Facilities
SECTION 5Process Equipment
SECTION 6Documentation and Records
SECTION 7Materials Management
SECTION 8Production and In-Process Controls
SECTION 9Packaging and Identification Labelling of APIs and Intermediates
SECTION 10Storage and Distribution
SECTION 11Laboratory Controls
SECTION 12Validation
SECTION 13Change Control
SECTION 14Rejection and Re-use of Materials
SECTION 15Complaints and Recalls
SECTION 16Contract Manufacturers Including Laboratories
SECTION 17Agents, Brokers, Traders, Distributors, Repackers, and Relabellers
SECTION 18Specific Guidance for APIs Manufactured by Cell Culture/Fermentation
SECTION 19APIs for Use in Clinical Trials

Audit topics

Quality unit independence
Quality responsibilities
Release of intermediates and APIs
Deviation management
CAPA governance
Quality risk management
Management review
Internal audit programme
Supplier quality oversight
Product quality review
Contamination prevention governance
Critical quality attributes
Critical process parameters
Quality agreements
Batch disposition after exceptions
Change quality oversight
Stability governance
Data integrity governance
Training effectiveness oversight
Quality culture escalation
Outsourced testing oversight
Regulatory/customer commitments
Key personnel qualification
Production supervision
Quality unit staffing
GMP training programme
Hygiene expectations
Consultant qualification
Temporary personnel control
Personnel access controls
Operator qualification
Training data integrity
Facility design
Segregated operations
Utilities qualification
Water systems
Containment controls
Environmental controls
Cleaning facilities
Pest control
Waste control
Maintenance access
Storage area controls
Laboratory facility controls
Equipment design
Equipment qualification
Equipment cleaning status
Preventive maintenance
Calibration programme
Computerized equipment
Equipment logs
Lubricants and coolants
Dedicated equipment rationale
Equipment transfer
Temporary equipment
Equipment decommissioning
Document control
Master production instructions
Batch production records
Laboratory records
Record corrections
Record retention
Specifications control
Certificate of analysis
SOP periodic review
Electronic records
Logbook governance
Deviation documentation
Material traceability records
Distribution records
Procedure training linkage
Data review by quality
Supplier qualification
Material receipt
Quarantine control
Material sampling
Material testing and release
Rejected material control
Retest and expiry control
Storage conditions
Dispensing control
Material reconciliation
Solvent control
Recovered materials
Packaging materials
Container closure suitability
Material status labelling
Supply chain change notification
Production instruction execution
Critical step control
In-process sampling
Yield monitoring
Process deviation response
Line clearance
Contamination prevention during open handling
Hold time control
Blending operations
Reprocessing control
Reworking control
Mother liquor reuse
Process equipment status before use
Process parameter recording
Process water use
Solvent recovery process
Campaign manufacturing
Step completion verification
Process transfer
Impurity profile control
Foreign matter prevention
Batch genealogy
Label control
Packaging line clearance
Container identification
Packaging material suitability
Packaging record review
Returned label control
Printed information accuracy
Tamper protection
Relabelling control
API storage conditions
Distribution authorization
Shipment traceability
Transport condition control
Returned API handling
Warehouse status controls
Distribution complaints link
Expired/retest overdue stock
QC laboratory independence
Analytical method control
OOS investigation
OOT trend handling
Reference standards
Reagents and solutions
Sample management
Stability programme
Impurity testing
Microbiological testing
Laboratory instruments
Chromatography data review
CoA data verification
Retesting controls
Laboratory deviations
Stability sample storage
Laboratory data backup
Validation master planning
Process validation strategy
Retrospective validation justification
Concurrent validation control
Cleaning validation strategy
Analytical method validation
Computerized system validation
Equipment qualification lifecycle
Validation deviations
Hold time validation
Transport validation
Revalidation triggers
Continued process verification
Validation protocol approval
Validation report conclusions
Process scale-up validation
Cleaning verification between campaigns
Legacy validation assessment
Change classification
Material supplier changes
Process changes
Equipment/facility changes
Analytical method changes
Change implementation control
Post-change effectiveness
Emergency changes
Rejected batch control
Reprocessing decision
Reworking protocol
Recovered solvent reuse
Returned material disposition
Salvage after abnormal event
Destruction records
Complaint intake
Complaint investigation
Recall procedure
Mock recall
Quality defect escalation
Complaint trend review
Contract acceptor qualification
Contract responsibility split
Contractor data review
Subcontracting control
Distributor qualification
Traceability through intermediaries
Repacking/relabelling oversight
Counterfeit/diversion risk
Cell bank control
Fermentation contamination control
Media and feed control
Harvest and purification control
Biological process deviations
Clinical API quality system
Clinical API documentation
Clinical API change control
Clinical API labelling and release

UK — MHRA Orange Guide / EU GMP Volume 4 — GMP for Medicinal ProductsGMP · Orange Guide 2022; EU GMP Volume 4 current15 chapter references · 108 topics

Chapter references and titles

MHRA-OGMHRA GMP Regulation and Licensing Context
Chapter 1Pharmaceutical Quality System
Chapter 2Personnel
Chapter 3Premises and Equipment
Chapter 4Documentation
Chapter 5Production
Chapter 6Quality Control
Chapter 7Outsourced Activities
Chapter 8Complaints and Product Recall
Chapter 9Self Inspection
Annex 1Manufacture of Sterile Medicinal Products
Annex 11Computerised Systems
Annex 15Qualification and Validation
Annex 16Certification by a Qualified Person and Batch Release
Annex 21Importation of Medicinal Products

Audit topics

GMP guidance basis
Manufacturer licence compliance
Risk-based inspection readiness
Orange Guide applicability
GMP/GDP interface
Senior management responsibility
PQS documentation
Adequate PQS resources
Quality Management scope
Lifecycle GMP
Risk-based PQS design
Process knowledge
Supplier control
State of control
Deviation investigation
CAPA effectiveness
QP certification before supply
Self-inspection process
People and quality assurance
Adequate personnel
Clear responsibilities
No excessive responsibility
Production and QC independence
Initial and continuing training
Hygiene programmes
Visitors and untrained personnel
Environmental location
Maintenance impact
Facility conditions
Pest protection
Unauthorised access prevention
Equipment suitability
Equipment cleaning
Defective equipment
Documentation as QA foundation
Batch history traceability
Document design and review
Document approval
Unambiguous documents
Document review cycle
Contemporaneous records
Record corrections
Equipment procedures
Batch processing records
Defined production procedures
Deviation avoidance
Yield and reconciliation
Mix-up prevention
Contamination protection
Status labelling
Restricted production access
Area and equipment clearance
Intermediate and bulk storage
Dispensed materials
Packaging procedures
Cross-contamination prevention
QC scope
QC decision involvement
QC resources
QC independence
QC access to production
Laboratory premises and equipment
Representative samples
Retained samples
Outsourced GMP control
Written contract
Contract acceptor assessment
Contract acceptor capability
Subcontracting control
Responsibility matrix
Complaint review
Recall system
Complaint responsibility
Complaint investigation
Other batch impact
Anytime recall readiness
Authority notification
GMP self-inspection
Independent detailed inspection
Self-inspection records
Sterile product contamination risks
Quality risk management
Contamination control strategy
Cleanroom classification
Clean area personnel training
Material transfer contamination
Environmental monitoring
Aseptic process simulation
Validation and qualification
Lifecycle risk management
Process owner and IT cooperation
Data security
Data back-up
Audit trail
Documentary evidence
QRM in validation
Validation planning
Validation master plan
Change impact
Process validation
QP batch certification
Supply chain documentation
QP information access
Unexpected deviation handling
MIA import responsibilities
Physical importation responsibility
QP certification of imports
Outsourced import activities

HACCP Food Safety — Codex CXC 1-1969 + Regulation (EC) No 852/2004Internal · Codex CXC 1-1969 Rev. 2022; Regulation (EC) No 852/200455 chapter references · 102 topics

Chapter references and titles

Reg. 852/2004 Art. 1-3Scope and operator responsibility
Reg. 852/2004 Art. 6Registration and competent authority
Reg. 852/2004 Art. 3General obligation
Codex CXC 1-1969 IntroGHP and HACCP structure
Codex CXC 1-1969 IntroFood safety objective
Reg. 852/2004 Annex II Ch. XIaFood safety culture
Codex HACCP Preliminary StepHACCP preliminary steps
Reg. 852/2004 Art. 5(2)(a)HACCP Principle 1
Codex HACCP Principle 1HACCP Principle 1
Reg. 852/2004 Art. 5(2)(b)HACCP Principle 2
Reg. 852/2004 Art. 5(2)(c)HACCP Principle 3
Reg. 852/2004 Art. 5(2)(d)HACCP Principle 4
Reg. 852/2004 Art. 5(2)(e)HACCP Principle 5
Reg. 852/2004 Art. 5(2)(f)HACCP Principle 6
Reg. 852/2004 Art. 5(2)(g)HACCP Principle 7
Reg. 852/2004 Art. 5(4)HACCP evidence
Reg. 852/2004 Art. 5(4)HACCP document currency
Reg. 852/2004 Art. 5(2)HACCP review
Codex HACCP Principle 6HACCP validation
Reg. 852/2004 Annex II Ch. IPremises
Reg. 852/2004 Annex II Ch. IIFood rooms
Reg. 852/2004 Annex II Ch. IIITemporary and mobile premises
Reg. 852/2004 Annex II Ch. VEquipment
Reg. 852/2004 Annex II Ch. VIIWater supply
Reg. 852/2004 Annex II Ch. IXFoodstuffs
Reg. 852/2004 Art. 4; Annex II Ch. IXTemperature control
Codex GHP OperationsControl of operation
Reg. 852/2004 Annex II Ch. XIHeat treatment
Codex GHP Maintenance and sanitationCleaning and sanitation
Codex GHP Pest controlPest control
Reg. 852/2004 Annex II Ch. VIFood waste
Reg. 852/2004 Annex II Ch. VIIIPersonal hygiene
Codex GHP Personal hygienePersonal hygiene
Reg. 852/2004 Annex II Ch. XIITraining
Reg. 852/2004 Annex II Ch. XWrapping and packaging
Codex Product informationProduct information
Reg. 852/2004 Annex II Ch. IVTransport
Reg. 178/2002 General Food LawTraceability
Codex GHP Product informationTraceability and withdrawal
Reg. 852/2004 Annex II allergen hygieneAllergen control
Codex HACCP Principle 1Allergen control
Codex GHP CleaningAllergen control
Reg. 852/2004 Art. 5(2)(g)Records
Codex GHP Corrective actionNonconformance handling
Codex GHP Product informationComplaints
Reg. 852/2004 Art. 4Specific hygiene measures
Reg. 852/2004 Annex II Ch. IXSupplier and ingredients
Reg. 852/2004 Annex II Ch. XPackaging and contact materials
Codex HACCP Principle 6Verification
Codex GHP Personal hygieneVisitors and helpers
Reg. 852/2004 Art. 5 proportionalitySmall operation flexibility
Codex GHP Control of operationOperational control
Reg. 852/2004 Annex II Ch. IXHigh-risk foods
Codex HACCP PlanHACCP plan
HACCP System OverviewFinal readiness

Audit topics

Food operation scope
Registration or notification
Control over all food stages
Prerequisite hygiene foundation
Safe and suitable food
Management commitment
Communication
Continuous improvement
Product description
Intended consumer
Shelf life and storage
Process flow diagram
Confirm the flow
Hazard identification
Biological hazards
Chemical hazards
Physical hazards
Allergen hazards
Risk evaluation
Control measures
Critical control points
Critical limits
Monitoring procedures
Corrective actions
Verification
Documents and records
Evidence to authority
Up-to-date documents
Review after modification
Validation before use
Clean and maintained premises
Layout prevents contamination
Handwashing facilities
Ventilation
Lighting
Food-contact surfaces
Floors, walls, ceilings
Windows and openings
Temporary premises hygiene
Facilities for personal hygiene
Food-contact equipment condition
Equipment cleanability
Calibration and control tools
Potable water
Ice and steam
Raw material acceptance
Storage protection
Temperature requirements
Cross-contamination
Cold chain
Cooking control
Cooling control
Reheating and hot holding
Heat treatment process
Cleaning programme
Cleaning chemicals
Verification of cleaning
Cleaning tools
Prevent pest access
Pest monitoring
Safe pest treatment
Waste removal
Waste containers
Waste storage
Cleanliness and clothing
Illness exclusion
Hand hygiene moments
Personal behaviour
Food hygiene training
HACCP training
Packaging material suitability
Packaging operation hygiene
Consumer instructions
Clean transport containers
Transport temperature
Ingredient traceability
Unsafe food response
Allergen storage
Recipe and label match
Allergen cleaning
Simple record set
Retention
Food safety incidents
Consumer complaints
Microbiological criteria
Sampling and analysis
Approved sources
Food-grade contact
Internal review
Record review
Review frequency
Visitor hygiene
Simple HACCP for low-risk operations
Safe hobby upgrade path
Start-up checks
End-of-work checks
Ready-to-eat foods
Vulnerable consumer foods
Leftovers and reuse
Plan contents
Roles and responsibility
Compliance readiness

CDSCO Schedule M — GMP for Pharmaceutical Products — G.S.R. 922(E), 2023 (Bharat)GMP · G.S.R. 922(E), 28 Dec 202337 chapter references · 50 topics

Chapter references and titles

Schedule M NoteScope and Documented Systems
Schedule M NoteManufacturing Premises Use
Part I 1.1Pharmaceutical Quality System (PQS)
Part I 1.2Pharmaceutical Quality System (PQS)
Part I 1.5Pharmaceutical Quality System (PQS)
Part I 2.1Quality Risk Management (QRM)
Part I 2.3Product Quality Review
Part I 3.1Good Manufacturing Practices
Part I 4Sanitation and Hygiene
Part I 5.2Qualification and Validation
Part I 5.3Qualification and Validation
Part I 5.4Qualification and Validation
Part I 5.11Qualification and Validation
Part I 6.1Complaints and Adverse Reaction
Part I 7Product Recalls
Part I 8Contract Production and Analysis
Part I 10.1Self-inspection and Quality Audit
Part I 10.8Suppliers’ Audits and Approval
Part I 11.1Personnel
Part I 11.2Personnel
Part I 11.3Personnel
Part I 11.5Personnel Hygiene
Part I 12.2Premises
Part I 12.6Production Areas
Part I 13Equipment
Part I 14Materials
Part I 15Production
Part I 16Good Practices in Production
Part I 17Documentation
Part I 17.3Documentation
Part I 18Good Practices in Quality Control
Part I 19Quality Control
Part I 19.9Stability Studies
Part I 20.1Computerised Systems
Part I 20.4Computerised Systems
Part I 20.6Computerised Systems
Part I 20.7Computerised Systems

Audit topics

Documented GMP methodology
Exclusive production premises
Manufacturer quality responsibility
Senior management accountability
Authorized batch certification
QRM process
Periodic product quality review
Defined manufacturing processes
GMP resources
Procedures and training execution
Manufacturing records and deviations
Batch traceability
Storage and distribution quality
Integrated sanitation programme
Validation master plan
DQ IQ OQ PQ evidence
Significant changes and validation impact
Analytical and cleaning validation
Complaint review and corrective action
Recall system availability
Contracted GMP activities
Self-inspection programme
Supplier approval
Qualified personnel and responsibilities
Organisational independence
Training programme
Health and hygiene controls
Premises layout and design
Environment and utilities
Dedicated and self-contained facilities
Equipment suitability and cleaning
Product-contact materials
Material quarantine and release
Starting and packaging material specifications
Production operations and controls
Line clearance and mix-up prevention
Yield and reconciliation
Controlled documentation system
Labels and status identification
Finished product labelling
Finished product specifications
QC laboratory controls
Representative sampling
Stability programme
Computerised system validation
Access and data-change controls
Manual data entry checks
Computerised system incidents and backup
Change control governance
State of control

Japan — PMDA/MHLW GMP Ministerial Order No. 179 — GMP for PharmaceuticalsGMP · Order No. 179 of 2004; latest amendment MHLW Order No. 90 of 2021; PMDA tentative translation updated 2024-06-21107 chapter references · 108 topics

Chapter references and titles

Article 1Purpose
Article 2(1)Definitions
Article 2(4)Definitions
Article 2(9)Definitions
Article 2(10)Definitions
Article 2(11)Definitions
Article 2(13)Definitions
Article 2(14)-(15)Definitions
Article 2(16)-(18)Definitions
Article 3Scope of Application
Article 3-2Product Authorization Requirements
Article 3-3Pharmaceutical Quality System
Article 3-3(i)Pharmaceutical Quality System
Article 3-3(ii)Pharmaceutical Quality System
Article 3-3(iii)Pharmaceutical Quality System
Article 3-3(vi)Pharmaceutical Quality System
Article 3-4Quality Risk Management
Article 3-4(2)Quality Risk Management
Article 4Production Department and Quality Department
Article 4(2)Production Department and Quality Department
Article 5Manufacturing Supervisor
Article 5(1)(ii)Manufacturing Supervisor
Article 5(1)(iv)Manufacturing Supervisor
Article 6Personnel
Article 6(2)-(3)Personnel
Article 6(4)Personnel
Article 7Pharmaceutical Product Specification File
Article 8Written Procedures
Article 8(i)Written Procedures
Article 8(ii)Written Procedures
Article 8(iii)Written Procedures
Article 8(iv)-(v)Written Procedures
Article 8(vi)-(vii)Written Procedures
Article 8(viii)Written Procedures
Article 8(ix)-(xi)Written Procedures
Article 8(xii)-(xvi)Written Procedures
Article 8-2Prevention of Cross-Contamination
Article 9Premises/Equipment
Article 9(1)(iii)Premises/Equipment
Article 9(1)(iv)Premises/Equipment
Article 9(1)(v)Premises/Equipment
Article 9(1)(vi)Premises/Equipment
Article 10Production Control
Article 10(iii)Production Control
Article 10(iv)Production Control
Article 10(v)-(vi)Production Control
Article 10(vii)-(ix)Production Control
Article 10(x)Production Control
Article 11Quality Management
Article 11(1)(i)-(iv)Quality Management
Article 11(1)(v)Quality Management
Article 11(1)(viii)Quality Management
Article 11(2)Quality Management
Article 11-2Stability Monitoring
Article 11-2(1)(ii)-(iv)Stability Monitoring
Article 11-3Review of Product Quality
Article 11-3(2)Review of Product Quality
Article 11-4Supplier Control for Starting Materials
Article 11-4(1)(iii)Supplier Control for Starting Materials
Article 11-4(2)Supplier Control for Starting Materials
Article 11-5Control of Outsourced Contractors
Article 11-5(1)(i)Control of Outsourced Contractors
Article 12Control of Product Release
Article 12(4)Control of Product Release
Article 13Validation
Article 13(1)(ii)Validation
Article 14Change Management
Article 14(1)(iv)Change Management
Article 14(2)Change Management
Article 15Deviation Management
Article 15(1)(ii)Deviation Management
Article 16Quality Information and Quality Defects
Article 16(2)Quality Information and Quality Defects
Article 17Management of Recalled Products
Article 17(2)Management of Recalled Products
Article 18Internal Audits
Article 18(2)Internal Audits
Article 19Education/Training
Article 19(iv)Education/Training
Article 20Management of Documents/Records
Article 20(1)(iii)Management of Documents/Records
Article 20(2)Management of Documents/Records
Article 21Active Ingredients — Quality Control
Article 21-2Active Ingredients — Stability Monitoring
Article 22Active Ingredients — Record Retention
Article 23Sterile Pharmaceuticals — Premises/Equipment
Article 23(iii)(c)Sterile Pharmaceuticals — Premises/Equipment
Article 23(iv)Sterile Pharmaceuticals — Premises/Equipment
Article 24Sterile Pharmaceuticals — Production Control
Article 24(iii)-(iv)Sterile Pharmaceuticals — Production Control
Article 24(vi)-(vii)Sterile Pharmaceuticals — Production Control
Article 25Sterile Pharmaceuticals — Education/Training
Article 25-2Biological Pharmaceuticals — Product Specification File
Article 26Biological Pharmaceuticals — Premises/Equipment
Article 27Biological Pharmaceuticals — Production Control
Article 27(ii)-(iv)Biological Pharmaceuticals — Production Control
Article 27(vi)-(vii)Biological Pharmaceuticals — Production Control
Article 27(ix)-(xii)Biological Pharmaceuticals — Production Control
Article 27(2)Biological Pharmaceuticals — Production Control
Article 27(2)(ii)Biological Pharmaceuticals — Production Control
Article 27(2)(v)-(vi)Biological Pharmaceuticals — Production Control
Article 28Biological Pharmaceuticals — Quality Control
Article 28(2)Biological Pharmaceuticals — Quality Control
Article 28(2)(ii)Biological Pharmaceuticals — Quality Control
Article 28(4)Biological Pharmaceuticals — Quality Control
Article 29Biological Pharmaceuticals — Education/Training
Article 30Biological Pharmaceuticals — Record Retention

Audit topics

Legal GMP standard
Product and intermediate product definition
Batch definition
Pharmaceutical quality system
Quality risk management definition
Stability monitoring definition
Validation definition
Corrective and preventive action
Controlled, clean and aseptic areas
Manufacturing site applicability
Authorization compliance
Effective PQS
Quality policy
Quality objectives
Policy dissemination
Resources and PQS review
QRM application
QRM records
Department structure
Quality independence
Manufacturing supervisor oversight
PQS implementation checks
Significant quality defects
Responsible persons
Adequate staffing
Responsibilities and management system
Product specification file
Quality department endorsement
Core written procedures
Sanitation and hygiene procedures
Production control procedures
Testing and laboratory procedures
Stability and product quality review procedures
Supplier and outsourced contractor procedures
Product release procedure
Validation, change and deviation procedures
Quality defects, recalls, audits, training and records
Cross-contamination prevention
Cleaning and maintenance
Contamination prevention in work rooms
Pass-through prevention
Dedicated handling rooms
Manufacturing water
Written production directions
Production according to directions
Batch production records
Material and packaging status
Equipment cleanliness, maintenance and calibration
Production control verification
Quality department tasks
Sampling and testing
Reference and retention samples
OOS investigation and CAPA
Imported product confirmation
Stability product selection
Stability parameters and impact assessment
Regular product quality review
PQR-driven rectification
Supplier qualification
Supplier periodic checks
Supplier agreements
Outsourced activities
Written contractor agreements
Release from manufacturing site
No release before decision
Validation triggers
Validation report to QA
Change impact assessment
Document revision and training
Post-change verification
Deviation occurrence
Significant deviation actions
Quality information records
Recall decision support
Recalled product storage
Rejected materials and products
Regular internal audits
Internal audit rectification
Systematic GMP training
Training effectiveness
Document lifecycle control
Record retention period
Record completeness and accuracy
API reference samples
API stability monitoring
API document retention
Sterile environmental cleanliness
Clean air and pressure differential
Sterile area segregation
Sterile work area control
Sterility-critical process controls
Sterile personnel hygiene and health
Sterile training
Biological specification file
Biological equipment segregation
Biological inactivation and contamination prevention
Biochemical process monitoring
Biological personnel and animals
Microorganism strain and origin material records
Cell/tissue mix-up prevention
Donor material receipt checks
Individual product delivery and distribution measures
Biological reference sample retention
Biological sample identification
Intermediate-stage critical testing
Biological quality record traceability
Biological training
Long-term biological record retention

FDA 21 CFR Parts 210 and 211 — cGMP for Drugs / Finished PharmaceuticalsGMP · eCFR current as of 2026-06-1112 chapter references · 66 topics

Chapter references and titles

21 CFR 210Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
21 CFR 211 Subpart AGeneral Provisions
21 CFR 211 Subpart BOrganization and Personnel
21 CFR 211 Subpart CBuildings and Facilities
21 CFR 211 Subpart DEquipment
21 CFR 211 Subpart EControl of Components and Containers/Closures
21 CFR 211 Subpart FProduction and Process Controls
21 CFR 211 Subpart GPackaging and Labeling Control
21 CFR 211 Subpart HHolding and Distribution
21 CFR 211 Subpart ILaboratory Controls
21 CFR 211 Subpart JRecords and Reports
21 CFR 211 Subpart KReturned and Salvaged Drug Products

Audit topics

Applicability of 21 CFR 210/211 to drug operations
Definitions and cGMP interpretation
Scope of finished pharmaceutical cGMP controls
cGMP definitions used by the site
Quality control unit responsibilities
Quality unit authority over approval and rejection
Personnel qualifications and experience
cGMP training program effectiveness
Personnel hygiene and health practices
Consultant qualification and records
Facility design and operational flow
Segregated or defined operational areas
Lighting adequacy for operations
Ventilation, air filtration and air-handling
Plumbing and water system suitability
Sewage and refuse disposal
Washing and toilet facilities
Sanitation and maintenance of buildings
Pest control program
Maintenance written procedures
Equipment design, size and location
Equipment surfaces and product contact materials
Equipment cleaning and maintenance
Automatic, mechanical and electronic equipment controls
Filters used in liquid processing
Receipt and storage of components and containers
Testing and approval or rejection of components
Container and closure testing and suitability
Use of approved components, containers and closures
Retesting of approved components
Rejected materials control
Drug product containers and closures cleaning
Written production and process control procedures
Charge-in and yield reconciliation
Calculation and batch formula control
Equipment identification during production
In-process materials and drug product sampling/testing
Time limits for production and process controls
Microbiological contamination control
Reprocessing and control of nonconforming product
Material examination and usage criteria
Labeling issuance and reconciliation
Packaging and labeling operations
Tamper-evident packaging requirements
Drug product inspection after packaging
Expiration dating controls
Warehouse procedures and storage conditions
Distribution procedures and traceability
Laboratory scientifically sound specifications and methods
Testing and release for distribution
Stability testing program
Special testing requirements
Reserve samples
Laboratory animals
Penicillin contamination testing
General records and reports controls
Equipment cleaning and use logs
Component and material records
Master production and control records
Batch production and control records
Production record review and unexplained discrepancies
Laboratory records and OOS documentation
Distribution records
Complaint files and investigation records
Returned drug product control
Salvaged drug product control

Terminology is provided as a practical navigation and discovery index. Users remain responsible for current source versions, legal applicability, audit scope and professional conclusions.