Pharmaceutical quality system tool · Africa and India

QMS Documentation Master Index

A practical, risk-based inventory of the controlled documents and records used to establish, operate and improve a pharmaceutical manufacturing site.

By S. BHATTIReviewed 20 October 2026142 document families

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Current-status note

Requirements checked to 20 October 2026.

PIC/S: PE 009-18 is the current GMP Guide and took effect on 24 September 2026.

Validation: PIC/S PI 006-4, the revised recommendations on qualification and validation, took effect on 1 October 2026.

European Union: the revised Chapter 4 and Annex 11 texts published in July 2025 remain consultation drafts; they are useful future-direction signals, not current binding text.

India: the revised Schedule M is the operating baseline after the limited small/medium-manufacturer extension ended on 31 December 2025. Product, licence and category-specific applicability still requires verification.

Use the tool correctly

An inventory and gap-assessment framework—not a ready-made SOP package.

Each row represents a control family that a manufacturing site should assess. It does not mean every site needs a separate document with that exact title. The right structure follows products, processes, technologies, licences, people and risk.

Africa is not one legal jurisdiction. Apply the requirements of each national authority, intended export market and procurement programme. In India, apply the current Drugs Rules, revised Schedule M, licence conditions and relevant central, state and product requirements.

Document architecture

Keep governance, instructions and evidence connected.

Level 1

Governance

Quality policy and manual, Site Master File, quality objectives, Validation Master Plan and management-review framework.

Level 2

System controls

SOPs, programmes, plans, agreements and standards that define how the pharmaceutical quality system operates.

Level 3

Operational instructions

Master formulae, batch and packaging instructions, specifications, methods, protocols and work instructions.

Level 4

Objective evidence

Forms, registers, logbooks, raw data, executed records, reports, trends and approved decisions.

External layer: keep legislation, GMP guides, pharmacopoeias, product registrations, engineering standards and customer commitments under controlled external-document monitoring.

Interactive implementation tool

Search the master document inventory.

Treat each row as a document family to assess—not a command to create a separate SOP. Combine documents where responsibilities and evidence remain clear, and add product, market and site-specific controls where your risk assessment requires them.

142document families

13system areas

98core GMP families

2026requirements review

142 document families shown

Requirements and practice reviewed 20 October 2026.

Index	Document family	Type / owner	Applicability	Minimum controlled evidence	Primary basis
GOV-001Governance and pharmaceutical quality system	Quality policy	PolicySenior management / QA	Core GMP	Approved policy, communication and periodic suitability review	PIC/S Ch. 1–2; ICH Q10
GOV-002Governance and pharmaceutical quality system	Quality manual or equivalent PQS description	ManualHead of Quality	Core GMP	Scope, process map, governance, responsibilities and interfaces	PIC/S 1.7; ICH Q10
GOV-003Governance and pharmaceutical quality system	Site Master File	Master fileQA	Core GMP	Current description of site, operations and GMP controls	PIC/S Ch. 4; WHO TRS 961 Annex 14
GOV-004Governance and pharmaceutical quality system	Quality objectives and performance indicators	Plan / registerSenior management / QA	Core GMP	Approved objectives, measures, owners, targets and follow-up	ICH Q10; PIC/S Ch. 1
GOV-005Governance and pharmaceutical quality system	Management review procedure and agenda	SOPSenior management / QA	Core GMP	Inputs, frequency, decisions, resources, actions and minutes	PIC/S 1.6; WHO data integrity
GOV-006Governance and pharmaceutical quality system	Organisation chart and quality-unit independence	Controlled chartHR / QA	Core GMP	Named roles, reporting lines, deputies and approval	PIC/S Ch. 2; WHO GMP
GOV-007Governance and pharmaceutical quality system	Quality governance committees and escalation pathway	Charter / SOPSenior management / QA	Risk-based	Terms of reference, quorum, escalation criteria and minutes	ICH Q10; ICH Q9(R1)
GOV-008Governance and pharmaceutical quality system	Quality risk management system	SOP / registerQA	Core GMP	Risk method, facilitators, register, review and risk acceptance	ICH Q9(R1); PIC/S Ch. 1
GOV-009Governance and pharmaceutical quality system	Quality culture and data-integrity governance programme	Policy / programmeSenior management / QA	Core GMP	Accountability, reporting channels, resourcing, metrics and review	WHO TRS 1033 Annex 4; PIC/S PI 041-1
GOV-010Governance and pharmaceutical quality system	Annual Product Quality Review / Product Quality Review	SOP / reportQA	Core GMP	Approved review, trend conclusions, CAPA and management decisions	PIC/S 1.10; WHO GMP
GOV-011Governance and pharmaceutical quality system	Quality-system effectiveness review	Protocol / reportQA	Risk-based	Process performance, recurring issues, maturity and improvement plan	ICH Q10; PIC/S Ch. 1
DOC-001Document control and data governance	Document and record control	SOPQA Documentation	Core GMP	Creation, review, approval, issue, change, withdrawal, archive and disposal	PIC/S Ch. 4; WHO GMP
DOC-002Document control and data governance	QMS document master index	RegisterQA Documentation	Core GMP	Current document identity, owner, revision, status, effective date and location	PIC/S 4.32
DOC-003Document control and data governance	Document numbering and taxonomy	Standard / SOPQA Documentation	Core GMP	Unique identification rules for policies, SOPs, forms, masters and records	PIC/S 4.3
DOC-004Document control and data governance	Template and master-form control	SOP / registerQA Documentation	Core GMP	Approved masters, issuance, reconciliation, access and obsolescence controls	PIC/S 4.1–4.6; WHO data integrity
DOC-005Document control and data governance	Good documentation practices	SOPQA	Core GMP	ALCOA+, entries, corrections, signatures, blanks, attachments and review	PIC/S 4.7–4.9; WHO TRS 1033 Annex 4
DOC-006Document control and data governance	Record retention and archival schedule	Policy / scheduleQA / Legal / IT	Core GMP	Record class, trigger, minimum period, media, owner and disposition	PIC/S 4.10–4.12; national law
DOC-007Document control and data governance	Controlled-copy issuance and reconciliation	SOP / logQA Documentation	Core GMP	Copy number, holder, issue, return, replacement and destruction	PIC/S Ch. 4
DOC-008Document control and data governance	External standards and regulatory-document control	SOP / registerRegulatory / QA	Core GMP	Source, version, applicability, change monitoring and impact assessment	PIC/S Ch. 4; ICH Q10
DOC-009Document control and data governance	Data governance framework and data-flow maps	Policy / mapQA / IT / Process owners	Core GMP	Critical data, creation, processing, review, transfer, storage and destruction	WHO TRS 1033 Annex 4; PIC/S PI 041-1
DOC-010Document control and data governance	Electronic signatures and identity attribution	SOPQA / IT	Conditional	Identity proofing, signature meaning, linkage, revocation and review	EU Annex 11; 21 CFR Part 11
DOC-011Document control and data governance	Scanning, true copies and certified-copy controls	SOPQA Documentation / IT	Conditional	Verification, metadata, legibility, completeness and source disposition	WHO data integrity; PIC/S PI 041-1
DOC-012Document control and data governance	Hybrid record-system controls	SOP / system descriptionQA / IT	Conditional	Authoritative record, interfaces, reconciliation and retrieval	PIC/S 4.1; WHO data integrity
DOC-013Document control and data governance	Translation and multilingual-document control	SOPQA Documentation	Conditional	Qualified translation, technical verification, equivalence and revision alignment	PIC/S 4.2–4.5
PER-001Personnel, training and hygiene	Job descriptions and authorised responsibilities	Controlled role profileHR / Department heads / QA	Core GMP	Competence, duties, authority, deputies and approval	PIC/S Ch. 2
PER-002Personnel, training and hygiene	GMP induction and continuing-training programme	ProgrammeHR / QA	Core GMP	Curriculum, frequency, trainers, records and overdue escalation	PIC/S Ch. 2; WHO GMP
PER-003Personnel, training and hygiene	Training needs analysis and role curricula	Matrix / planDepartment heads / QA	Core GMP	Role-to-task mapping, prerequisites and qualification status	PIC/S Ch. 2
PER-004Personnel, training and hygiene	Training effectiveness and personnel qualification	SOP / recordsDepartment heads / QA	Core GMP	Assessment, observation, demonstration, retraining and authorization	PIC/S Ch. 2; ICH Q10
PER-005Personnel, training and hygiene	Personnel hygiene, gowning and conduct	SOPProduction / QA / HR	Core GMP	Health, clothing, washing, behaviour and access requirements	PIC/S Ch. 2
PER-006Personnel, training and hygiene	Medical examination and illness reporting	SOP / confidential recordOccupational health / HR	Core GMP	Fitness assessment, restrictions, reporting and return to duty	PIC/S 2.16
PER-007Personnel, training and hygiene	Contractor, consultant and temporary-worker qualification	SOP / registerUser department / QA	Core GMP	Selection, induction, supervision, access and retained credentials	PIC/S 2.22; Ch. 7
PER-008Personnel, training and hygiene	Visitor access and GMP briefing	SOP / logSecurity / QA	Risk-based	Authorization, escort, hygiene, confidentiality and entry records	PIC/S Ch. 2–3
ENG-001Premises, utilities, equipment and engineering	Facility design basis and GMP zoning philosophy	Master / design basisEngineering / QA	Core GMP	Flows, segregation, containment, cleaning, maintenance and expansion assumptions	PIC/S Ch. 3; WHO GMP
ENG-002Premises, utilities, equipment and engineering	Premises and room-data register	RegisterEngineering / QA	Core GMP	Room use, grade, finishes, pressure, temperature, humidity and utilities	PIC/S Ch. 3
ENG-003Premises, utilities, equipment and engineering	Equipment master list and criticality assessment	Register / assessmentEngineering / User departments / QA	Core GMP	Unique ID, location, intended use, criticality and lifecycle status	PIC/S Ch. 3; Annex 15
ENG-004Premises, utilities, equipment and engineering	Preventive maintenance system	SOP / plans / recordsEngineering	Core GMP	Asset plans, frequencies, work orders, breakdowns, review and backlog	PIC/S Ch. 3–4
ENG-005Premises, utilities, equipment and engineering	Calibration and metrology programme	SOP / plans / recordsEngineering / QC	Core GMP	Standards, traceability, limits, labels, out-of-tolerance assessment and recall	PIC/S 3.41; Ch. 4
ENG-006Premises, utilities, equipment and engineering	HVAC operation, monitoring and maintenance	SOP / planEngineering / QA	Core GMP	Set points, alarms, filters, pressure, recovery, cleaning and trends	PIC/S Ch. 3; WHO HVAC guidance
ENG-007Premises, utilities, equipment and engineering	Pharmaceutical water-system operation and monitoring	SOP / programmeEngineering / QC / QA	Conditional	Generation, storage, distribution, sanitisation, sampling, alerts and trends	WHO TRS 1033 Annex 3
ENG-008Premises, utilities, equipment and engineering	Compressed gases, steam and other process utilities	SOP / programmeEngineering / QC	Conditional	Quality specification, monitoring, maintenance and point-of-use control	PIC/S Ch. 3; risk assessment
ENG-009Premises, utilities, equipment and engineering	Cleaning and sanitation of premises	SOP / schedule / recordsProduction / Housekeeping / QA	Core GMP	Methods, agents, frequencies, responsibilities, verification and logs	PIC/S Ch. 3–5
ENG-010Premises, utilities, equipment and engineering	Pest-control programme	SOP / contract / trendsAdministration / QA	Core GMP	Map, approved chemicals, inspections, findings, trends and CAPA	PIC/S Ch. 3
ENG-011Premises, utilities, equipment and engineering	Engineering drawings and configuration control	SOP / drawing registerEngineering / QA	Core GMP	Approved as-built drawings, revision, issue and change linkage	PIC/S Ch. 3–4; Annex 15
ENG-012Premises, utilities, equipment and engineering	Equipment cleaning, use and maintenance logbooks	LogbooksUser departments / Engineering	Core GMP	Chronological use, cleaning, calibration, maintenance and repair records	PIC/S 4.31
MAT-001Materials, suppliers and warehousing	Supplier and service-provider qualification	SOP / registerProcurement / QA	Core GMP	Risk tier, due diligence, audit, approval, monitoring and disqualification	PIC/S Ch. 1, 5 and 7
MAT-002Materials, suppliers and warehousing	Approved supplier and manufacturer list	RegisterQA / Procurement	Core GMP	Material/service scope, site, approval status, conditions and review date	PIC/S Ch. 5
MAT-003Materials, suppliers and warehousing	Quality and technical agreements	Agreement / registerQA / Business owner	Conditional	Responsibilities, change, deviations, data, audit, release and communication	PIC/S Ch. 7; ICH Q10
MAT-004Materials, suppliers and warehousing	Material specifications	SpecificationQC / QA	Core GMP	Identity, compendial/internal tests, limits, sampling, storage and retest/expiry	PIC/S 4.13–4.16
MAT-005Materials, suppliers and warehousing	Receipt, quarantine and status control	SOP / recordsWarehouse / QA	Core GMP	Verification, damage checks, identity, segregation, labels and system status	PIC/S 4.22; Ch. 5
MAT-006Materials, suppliers and warehousing	Sampling of starting and packaging materials	SOP / plan / recordsQC / Warehouse	Core GMP	Sampling plan, tools, locations, precautions, containers and traceability	PIC/S Ch. 4 and 6; WHO sampling guidance
MAT-007Materials, suppliers and warehousing	Material testing, release and rejection	SOP / recordsQC / QA	Core GMP	Testing status, review, disposition, labels and ERP/LIMS alignment	PIC/S Ch. 5–6
MAT-008Materials, suppliers and warehousing	Storage, FEFO and environmental monitoring	SOP / logs / trendsWarehouse / QA	Core GMP	Mapped conditions, alarms, excursions, rotation and trend review	PIC/S Ch. 3 and 5; GDP
MAT-009Materials, suppliers and warehousing	Dispensing and material issuance	SOP / recordsWarehouse / Production / QA	Core GMP	Verification, weighing, reconciliation, labels, containment and return	PIC/S Ch. 5
MAT-010Materials, suppliers and warehousing	Inventory reconciliation and discrepancy investigation	SOP / reportsWarehouse / Finance / QA	Core GMP	Cycle counts, variance thresholds, investigation and approval	PIC/S Ch. 5; data integrity
MAT-011Materials, suppliers and warehousing	Returned, damaged, expired and obsolete materials	SOP / registerWarehouse / QA	Core GMP	Segregation, assessment, disposition, destruction and reconciliation	PIC/S Ch. 5
MAT-012Materials, suppliers and warehousing	Cold-chain material handling	SOP / qualification recordsWarehouse / QA	Conditional	Receipt, storage, monitoring, alarms, transport and excursion assessment	GDP; product requirements
PRD-001Production and packaging operations	Master manufacturing formula and processing instructions	Master instructionProduction / QA	Core GMP	Formula, equipment, process sequence, parameters, IPCs, yields and precautions	PIC/S 4.17–4.18
PRD-002Production and packaging operations	Batch manufacturing record	Executed recordProduction / QA	Core GMP	Issued copy, materials, equipment, operators, process data, yields and review	PIC/S 4.20
PRD-003Production and packaging operations	Master packaging instructions	Master instructionPackaging / QA	Core GMP	Pack configuration, components, coding, specimens, line clearance and reconciliation	PIC/S 4.19
PRD-004Production and packaging operations	Batch packaging record	Executed recordPackaging / QA	Core GMP	Line identity, materials, codes, checks, yields, reconciliation and approval	PIC/S 4.21
PRD-005Production and packaging operations	Line clearance and area readiness	SOP / checklistProduction / Packaging / QA	Core GMP	Previous-product removal, cleanliness, status, documents and materials	PIC/S Ch. 5
PRD-006Production and packaging operations	In-process controls and sampling	SOP / recordsProduction / IPQA / QC	Core GMP	Test method, frequency, limits, action, equipment and traceability	PIC/S Ch. 5–6
PRD-007Production and packaging operations	Yield and reconciliation controls	SOP / recordProduction / Packaging / QA	Core GMP	Stages, theoretical/actual quantities, limits and discrepancy investigation	PIC/S Ch. 5
PRD-008Production and packaging operations	Cleaning and equipment-changeover procedures	SOP / recordsProduction / QA	Core GMP	Method, sequence, hold times, status labelling, verification and release	PIC/S Ch. 3 and 5; validation guidance
PRD-009Production and packaging operations	Cross-contamination and mix-up prevention	SOP / risk assessmentProduction / QA / Engineering	Core GMP	Hazard evaluation, segregation, campaigns, cleaning and monitoring	PIC/S Ch. 3 and 5; HBEL guidance
PRD-010Production and packaging operations	Process and bulk hold-time controls	SOP / study / recordProduction / QA / QC	Risk-based	Defined stages, conditions, limits, labelling and excursion assessment	WHO TRS 992 Annex 4
PRD-011Production and packaging operations	Reprocessing, rework and recovery	SOP / authorizationProduction / QA / Regulatory	Conditional	Scientific justification, approval, validation, records and regulatory impact	PIC/S Ch. 5
PRD-012Production and packaging operations	Printed packaging material and coding control	SOP / reconciliationPackaging / QA / Warehouse	Core GMP	Receipt, secure storage, issue, specimen, online checks, return and destruction	PIC/S Ch. 5
PRD-013Production and packaging operations	Manufacturing status labels and identification	SOP / label mastersProduction / Warehouse / QA	Core GMP	Material, room, equipment and batch status with controlled label issuance	PIC/S Ch. 3 and 5
LAB-001Quality control, microbiology and stability	Quality-control laboratory manual	ManualHead of QC	Core GMP	Organisation, scope, workflow, review, release interfaces and safety	PIC/S Ch. 6; WHO TRS 1052 Annex 4
LAB-002Quality control, microbiology and stability	Specifications and analytical test procedures	Specification / methodQC / QA	Core GMP	Approved requirements, method, system suitability, calculations and limits	PIC/S Ch. 4 and 6
LAB-003Quality control, microbiology and stability	Sampling plans for materials and products	Plan / SOPQC / QA	Core GMP	Population, locations, quantities, method, containers and rationale	PIC/S Ch. 6; WHO sampling guidance
LAB-004Quality control, microbiology and stability	Analytical worksheets, notebooks and raw-data control	Record / SOPQC / QA	Core GMP	Contemporaneous raw data, calculations, review, corrections and attachments	PIC/S Ch. 4 and 6; WHO data integrity
LAB-005Quality control, microbiology and stability	Laboratory instrument lifecycle	SOP / registerQC / Engineering / QA	Core GMP	Qualification, calibration, maintenance, access, software and status	WHO TRS 1052 Annex 4; Annex 15
LAB-006Quality control, microbiology and stability	Reference standards and working standards	SOP / registerQC	Core GMP	Qualification, receipt, storage, potency correction, use and expiry	PIC/S Ch. 6; WHO QC laboratory guidance
LAB-007Quality control, microbiology and stability	Reagents, volumetric solutions and culture media	SOP / logsQC / Microbiology	Core GMP	Preparation, standardisation, growth promotion, labelling, storage and expiry	PIC/S Ch. 6; WHO QC laboratory guidance
LAB-008Quality control, microbiology and stability	Laboratory result review and second-person verification	SOP / checklistQC / QA	Core GMP	Raw-data completeness, calculations, audit trail, specification and approval	PIC/S Ch. 6; WHO data integrity
LAB-009Quality control, microbiology and stability	OOS, OOT and atypical-result investigation	SOP / recordsQC / QA	Core GMP	Laboratory assessment, hypotheses, manufacturing review, impact and CAPA	PIC/S Ch. 6; FDA OOS guidance
LAB-010Quality control, microbiology and stability	Stability programme and protocols	SOP / protocol / scheduleQC / Regulatory / QA	Core GMP	Batches, conditions, pulls, tests, trends, excursions and commitments	ICH Q1; PIC/S Ch. 6
LAB-011Quality control, microbiology and stability	Reserve and retention samples	SOP / inventoryQC / QA	Core GMP	Quantity, storage, access, examination, period and disposal	PIC/S Annex 19 (rev. 2026)
LAB-012Quality control, microbiology and stability	Environmental and microbiological monitoring	Programme / recordsMicrobiology / QA / Production	Conditional	Locations, frequencies, methods, limits, trends, isolates and response	Product/process requirements; WHO/PIC/S
LAB-013Quality control, microbiology and stability	Laboratory data and chromatography governance	SOP / controlsQC / IT / QA	Conditional	Sequences, processing methods, integrations, audit trails, review and backup	WHO TRS 1025 Annex 4; data-integrity guidance
LAB-014Quality control, microbiology and stability	Laboratory investigation and invalidation governance	SOP / decision recordQC / QA	Core GMP	Scientific rationale, authorization, retest/resample controls and trend review	PIC/S Ch. 6; WHO data integrity
VAL-001Qualification, validation and technology transfer	Validation Master Plan	Master planValidation / QA	Core GMP	Policy, scope, responsibilities, lifecycle, schedules, acceptance and governance	PIC/S Annex 15 and PI 006-4; WHO TRS 1019 Annex 3
VAL-002Qualification, validation and technology transfer	User requirements specifications	SpecificationUser department / Engineering / QA	Core GMP	Intended use, GMP/data needs, capacity, environment, alarms and lifecycle support	PIC/S Annex 15 and PI 006-4; ICH Q9(R1)
VAL-003Qualification, validation and technology transfer	Design qualification and design review	Protocol / reportEngineering / User / QA	Core GMP	Traceability of design to approved requirements and risks	PIC/S Annex 15 and PI 006-4
VAL-004Qualification, validation and technology transfer	Commissioning and turnover packages	Plan / dossierEngineering / Validation	Risk-based	Tests, certificates, drawings, manuals, punch items and handover acceptance	PIC/S PI 006-4; good engineering practice
VAL-005Qualification, validation and technology transfer	Installation, operational and performance qualification	Protocol / reportValidation / User / QA	Core GMP	Pre-approved tests, deviations, traceability, conclusion and release	PIC/S Annex 15 and PI 006-4
VAL-006Qualification, validation and technology transfer	Process validation and continued process verification	Protocol / report / programmeProduction / Validation / QA / QC	Core GMP	Process knowledge, PPQ design, sampling, acceptance, trends and lifecycle review	PIC/S PI 006-4; WHO validation guidance
VAL-007Qualification, validation and technology transfer	Cleaning validation	Protocol / report / matrixValidation / Production / QA / QC	Core GMP	Worst case, limits, sampling, recovery, hold times, residues and lifecycle review	PIC/S PI 006-4; WHO HBEL guidance
VAL-008Qualification, validation and technology transfer	Analytical method validation and verification	Protocol / reportQC / QA	Core GMP	Characteristics, acceptance criteria, data, deviations and approved conclusion	ICH Q2(R2); WHO QC laboratory guidance
VAL-009Qualification, validation and technology transfer	Analytical method transfer	Protocol / reportSending / Receiving QC / QA	Conditional	Responsibilities, method, comparative design, acceptance and investigation	WHO technology-transfer guidance
VAL-010Qualification, validation and technology transfer	Computerised-system validation	Plan / protocol / reportSystem owner / IT / QA	Conditional	Requirements, risk, testing, data migration, security, release and periodic review	EU Annex 11; GAMP principles; 21 CFR Part 11
VAL-011Qualification, validation and technology transfer	Transport and shipping qualification	Protocol / reportSupply chain / QA	Conditional	Routes, profiles, packaging, challenge tests, monitoring and excursion control	PIC/S PI 006-4; GDP; product requirements
VAL-012Qualification, validation and technology transfer	Technology-transfer governance	SOP / plan / reportTechnical / Production / QC / QA	Conditional	Knowledge package, gap analysis, responsibilities, transfer batches and closure	WHO TRS 1044 Annex 4; ICH Q10
QEV-001Quality events, audit and continual improvement	Deviation and nonconformance management	SOP / recordsAll functions / QA	Core GMP	Immediate control, classification, investigation, impact, CAPA and closure	PIC/S Ch. 1; ICH Q10
QEV-002Quality events, audit and continual improvement	Corrective and preventive action management	SOP / registerProcess owners / QA	Core GMP	Action quality, risk priority, ownership, due dates, changes and effectiveness	ICH Q10; ICH Q9(R1)
QEV-003Quality events, audit and continual improvement	CAPA effectiveness checks	SOP / evidence planProcess owners / QA	Core GMP	Predefined criteria, timing, evidence, decision and further action	ICH Q10; PIC/S PI 054-1
QEV-004Quality events, audit and continual improvement	Change control	SOP / registerAll functions / QA	Core GMP	Classification, impact, risk, approvals, implementation, effectiveness and regulatory assessment	PIC/S Ch. 1; ICH Q10
QEV-005Quality events, audit and continual improvement	Temporary change and planned-deviation control	SOP / registerProcess owners / QA	Risk-based	Justification, controls, duration, approvals, monitoring and closure	PQS / QRM principles
QEV-006Quality events, audit and continual improvement	Internal audit and self-inspection	SOP / programme / reportsQA	Core GMP	Risk-based schedule, independence, evidence, findings, CAPA and follow-up	PIC/S Ch. 9
QEV-007Quality events, audit and continual improvement	Regulatory inspection readiness and response	SOP / trackerQA / Regulatory	Core GMP	Hosting, document room, response review, commitments and evidence	National requirements; PQS
QEV-008Quality events, audit and continual improvement	Quality metrics and trend management	SOP / dashboardsQA / Process owners	Risk-based	Definitions, data verification, signals, escalation and management review	ICH Q10; WHO data integrity
QEV-009Quality events, audit and continual improvement	Recurring-event and cross-system signal detection	SOP / review recordQA	Risk-based	Taxonomy, periodic review, linkage, escalation and systemic CAPA	ICH Q10; ICH Q9(R1)
QEV-010Quality events, audit and continual improvement	Root-cause analysis methods and facilitation	SOP / guideQA / Investigators	Core GMP	Evidence standards, tool selection, causal verification and human factors	ICH Q9(R1); PQS practice
QEV-011Quality events, audit and continual improvement	Quality defect and critical-event escalation	SOP / contact matrixQA / Senior management	Core GMP	Severity, notification, decision authority, regulator/customer communication and records	PIC/S Ch. 8
QEV-012Quality events, audit and continual improvement	Quality action and commitment tracking	RegisterQA	Core GMP	Source, owner, due date, dependency, evidence, extension and closure	ICH Q10
QEV-013Quality events, audit and continual improvement	Continual-improvement programme	Programme / portfolioSenior management / QA	Risk-based	Opportunities, prioritisation, benefits, controls and sustainability review	ICH Q10
CSV-001Computerised systems and digital records	GxP computerised-system inventory and criticality	Register / assessmentIT / System owners / QA	Conditional	System, version, owner, GxP use, data criticality, validation and hosting	EU Annex 11; WHO data integrity
CSV-002Computerised systems and digital records	Computerised-system lifecycle and validation	SOPIT / System owners / QA	Conditional	Concept, requirements, risk, testing, release, operation, change and retirement	EU Annex 11; 21 CFR Part 11
CSV-003Computerised systems and digital records	User access and privileged-account management	SOP / access registerSystem owners / IT / QA	Conditional	Role design, approval, unique accounts, periodic review and prompt revocation	WHO data integrity; PIC/S PI 041-1
CSV-004Computerised systems and digital records	Audit-trail configuration and review	SOP / review recordsProcess owners / QA / IT	Conditional	Critical events, frequency, reviewer, exceptions, escalation and evidence	WHO data integrity; EU Annex 11
CSV-005Computerised systems and digital records	Backup, restore and disaster recovery	SOP / test recordsIT / System owners	Conditional	Scope, frequency, segregation, restore tests, recovery objectives and failures	EU Annex 11; WHO data integrity
CSV-006Computerised systems and digital records	Data migration, transfer and interface verification	SOP / protocolIT / System owners / QA	Conditional	Mapping, completeness, accuracy, reconciliation, exceptions and approval	WHO data integrity; EU Annex 11
CSV-007Computerised systems and digital records	Electronic master data and configuration control	SOP / registerSystem owners / QA / IT	Conditional	Creation, verification, approval, release, change history and periodic review	WHO data integrity; PIC/S Ch. 4
CSV-008Computerised systems and digital records	Periodic review of computerised systems	SOP / reportSystem owners / IT / QA	Conditional	Changes, incidents, access, audit trail, performance, validation and obsolescence	EU Annex 11
CSV-009Computerised systems and digital records	Cloud, hosted service and IT supplier assurance	SOP / assessment / agreementIT / Procurement / QA	Conditional	Due diligence, data location, security, availability, audit, exit and continuity	WHO data integrity; EU Annex 11
CSV-010Computerised systems and digital records	Computerised-system incident and continuity management	SOP / recordsIT / System owners / QA	Conditional	Detection, data impact, workaround, recovery, investigation and CAPA	EU Annex 11; ICH Q10
DSP-001Distribution, complaints, returns and recall	Finished-product release and certification	SOP / release recordQA / Authorised release role	Core GMP	Batch review, deviations, OOS, validation, regulatory status and disposition	PIC/S Ch. 1, 4 and 6
DSP-002Distribution, complaints, returns and recall	Distribution records and batch traceability	SOP / recordsSupply chain / QA	Core GMP	Customer, batch, quantity, date, destination and retrieval	PIC/S 4.28; GDP
DSP-003Distribution, complaints, returns and recall	Transport, dispatch and delivery controls	SOP / recordsSupply chain / QA	Core GMP	Approved routes/providers, conditions, security, monitoring and proof of delivery	GDP
DSP-004Distribution, complaints, returns and recall	Product complaint management	SOP / registerQA / Customer service	Core GMP	Intake, triage, investigation, sample, trend, response and regulatory assessment	PIC/S Ch. 8
DSP-005Distribution, complaints, returns and recall	Product quality defect and market action	SOP / recordsQA / Regulatory / Senior management	Core GMP	Risk evaluation, authority consultation, action, communication and follow-up	PIC/S Ch. 8
DSP-006Distribution, complaints, returns and recall	Recall and mock-recall programme	SOP / reportsRecall committee / QA	Core GMP	Decision, classification, contacts, reconciliation, effectiveness and periodic challenge	PIC/S Ch. 8
DSP-007Distribution, complaints, returns and recall	Returned-product assessment and disposition	SOP / recordsWarehouse / QA	Core GMP	Identity, conditions, history, tamper status, decision and destruction	PIC/S Ch. 5 and 8
DSP-008Distribution, complaints, returns and recall	Suspected falsified or diverted product response	SOP / recordsQA / Security / Regulatory	Risk-based	Authentication, quarantine, investigation, authorities and supply-chain action	PIC/S Ch. 8; WHO guidance
REG-001Regulatory and product lifecycle	Manufacturing licences, GMP certificates and permits register	RegisterRegulatory / QA	Core GMP	Authority, scope, number, conditions, validity, renewal owner and evidence	National law
REG-002Regulatory and product lifecycle	Product registration and marketing-authorisation register	RegisterRegulatory	Core GMP	Product, strength, pack, market, licence, status, commitments and variations	National law; ICH CTD
REG-003Regulatory and product lifecycle	Regulatory commitment and post-approval action tracker	RegisterRegulatory / QA	Core GMP	Commitment, market, owner, due date, evidence and closure	Marketing authorisations
REG-004Regulatory and product lifecycle	Variation and regulatory-change assessment	SOP / recordsRegulatory / QA	Core GMP	Change classification, market impact, submission, approval and implementation controls	National variation rules; ICH Q12
REG-005Regulatory and product lifecycle	Registered-detail versus site-master reconciliation	SOP / reviewRegulatory / QA / Technical	Core GMP	Formula, process, sites, methods, specifications, packs and commitments	PIC/S Ch. 4; marketing authorisation
REG-006Regulatory and product lifecycle	Artwork, label and patient-information control	SOP / masters / registerRegulatory / Packaging / QA	Core GMP	Approved text, proofs, version, market, implementation and obsolescence	Marketing authorisation; PIC/S Ch. 5
REG-007Regulatory and product lifecycle	Product lifecycle knowledge and dossier archive	SOP / indexRegulatory / Technical / QA	Core GMP	Development, transfer, validation, changes, annual reviews and submissions	ICH Q10; ICH Q12
REG-008Regulatory and product lifecycle	Pharmacovigilance and product-safety interface	SOP / agreementSafety / Regulatory / QA	Conditional	Complaint/adverse-event triage, exchange, reconciliation and escalation	National pharmacovigilance requirements
SPC-001Specialised and conditional systems	Sterile manufacturing contamination-control strategy	Strategy / programmeQA / Production / Engineering / Microbiology	Product-specific	Integrated facility, process, personnel, monitoring and sterility-assurance controls	EU/PIC/S Annex 1; WHO sterile GMP
SPC-002Specialised and conditional systems	Highly potent, sensitising or hazardous-product control	Risk assessment / programmeEHS / QA / Production / Engineering	Product-specific	HBEL, containment, dedication, cleaning, monitoring and waste controls	PIC/S Ch. 3 and 5; WHO hazardous GMP
SPC-003Specialised and conditional systems	Beta-lactam or special-segregation operations	Programme / SOP setQA / Production / Engineering	Product-specific	Dedicated facilities/systems, flows, cleaning, monitoring and material/personnel controls	National GMP; product hazard
SPC-004Specialised and conditional systems	Biologicals, vaccines or biotechnology products	Product-specific systemTechnical / QA / Production / QC	Product-specific	Seed/cell banks, biosafety, asepsis, cold chain and specialised testing	WHO/PIC/S specialised annexes
SPC-005Specialised and conditional systems	Investigational medicinal-product controls	Product-specific systemQA / Clinical supply	Product-specific	Randomisation/blinding, release, reconciliation, returns, destruction and trial records	PIC/S Annex 13; WHO investigational-product GMP
SPC-006Specialised and conditional systems	Contract manufacture, testing or distribution	Governance packageBusiness owner / QA	Conditional	Qualification, agreements, transfer, oversight, data, audit and continuity	PIC/S Ch. 7
SPC-007Specialised and conditional systems	Import, export and customer-market compliance	Register / SOPRegulatory / Supply chain / QA	Jurisdiction-specific	Permits, market conditions, certificates, dossiers, customer requirements and renewals	Destination-country law
SPC-008Specialised and conditional systems	Environmental, occupational safety and emergency response	Management systemEHS / Engineering / HR	Jurisdiction-specific	Risk assessments, permits, waste, exposure, incidents, drills and statutory records	National EHS law; GMP interfaces

Interpretation: “Core GMP” means normally expected for a conventional finished-product manufacturer. Other labels require a documented applicability decision based on products, technologies, markets, licences and risk.

Your authoritative register

Minimum fields for each controlled document.

The downloadable CSV is a coverage assessment. Your live master index should also control the following lifecycle fields.

Unique document ID and exact title

System area, process and document type

Owner, author, reviewers and approving role

Current revision, status and effective date

Previous or superseded document reference

Review basis, review date and event triggers

Linked forms, templates, records and systems

Controlled medium, location and source of truth

Training or qualification requirement

Retention trigger, minimum period and archive owner

Regulatory, product or technical basis

Sites, departments, products and markets in scope

Controlled lifecycle

Manage the decision trail from need to disposal.

01Need
Identify a regulatory, process, product, risk or business-control need.
02Draft
Use competent authors, approved templates and the actual operating process.
03Review and approve
Verify technical correctness, interfaces, usability and Quality authorization.
04Prepare and train
Release forms, systems, copies and competence before the effective date.
05Issue and use
Make only the effective version available where work and decisions occur.
06Review and improve
Use changes, events, trends, audit results and regulatory updates as triggers.
07Withdraw and archive
Prevent unintended use while preserving complete, retrievable history.
08Retain or dispose
Apply approved triggers, periods, legal holds and documented destruction.

Current control practice

Move beyond an SOP list.

Control every format

Apply one lifecycle to paper, electronic and hybrid instructions and records. Define which copy or system is authoritative and how components are reconciled.

Map critical data

Show where GMP data are created, transformed, reviewed, transferred, stored, backed up, retained and destroyed—not only where the final report is filed.

Review by risk and event

Set review logic according to criticality, change and performance. A universal two-year SOP review cycle is not a regulatory rule and must not replace event-driven review.

Govern electronic masters

Control templates, master data, roles, audit trails, interfaces, backups, migration, suppliers, periodic review and system retirement through the validated lifecycle.

Measure the system, not the count

A large SOP library is not evidence of an effective PQS. Monitor overdue documents, obsolete copies, training readiness, recurring events and record-review defects.

Keep external requirements live

Assign owners to monitor legislation, pharmacopoeias, GMP guides, product licences and customer requirements and to document the impact of each relevant change.

30–60 day implementation sequence

Convert the reference index into your controlled system.

Set scope and process map

Define sites, dosage forms, laboratories, warehouses, utilities, outsourced activities, markets and GxP systems covered.

Import the present inventory

Bring active, draft, superseded and archived documents into one reconciled list, including forms and electronic masters.

Classify and remove ambiguity

Assign every item a family, owner, status, source of truth and relationship to its records. Resolve duplicates and uncontrolled copies.

Assess the 13 system areas

Use the interactive index to record present, absent, not applicable, duplicate or improvement-required decisions with rationale.

Prioritise by patient and data risk

Address release, sterility or contamination, identity, traceability, critical utilities, data integrity and regulatory commitments first.

Design the usable hierarchy

Combine related controls where sensible, keep instructions at the point of use and separate stable policy from frequently changing operational detail.

Assign lifecycle accountability

Confirm authors, technical reviewers, Quality approvers, document administrators, trainers, record custodians and system owners.

Connect training and effective use

Do not make a document effective until copies, systems, materials, users and competence evidence are ready.

Approve gaps and remediation

Obtain management agreement on risk, interim controls, resources, dates and evidence for closure.

Run a monthly health review

Trend overdue reviews, pending training, obsolete-copy returns, document errors, record defects and open remediation actions.

Common failure patterns

A master index can still hide weak control.

Failure pattern	Practical interpretation
One SOP for every row	The index describes control families. One well-designed procedure may govern several related records, forms or subprocesses.
Generic internet procedures	A document that does not match actual people, equipment, products, systems and licences creates inspection and execution risk.
Several competing master lists	A spreadsheet, eQMS and department register can quietly disagree. Define one authoritative inventory and reconcile interfaces.
Uncontrolled blank forms	Blank templates can create GMP records and therefore require master control, version status, access and—where used—issuance or reconciliation.
Paper and electronic halves do not meet	Hybrid records fail when the authoritative record, links, sequence, review responsibility and retention are not defined.
Calendar review without process review	Renewing a revision number without checking changes, deviations, audit findings, user feedback and regulatory updates adds little control.
Records without a retention owner	A retention period alone is insufficient. Define the trigger, medium, archive, retrieval, legal hold, destruction approval and evidence.
External standards go stale	Pharmacopoeias, GMP guides, registrations and technical standards require monitored versions and documented applicability decisions.

Regional application

Build one coherent PQS, then map every legal and market obligation.

African manufacturing sites

Start with the competent national medicines authority and local manufacturing licence. Add WHO GMP as a strong common baseline, then map regional harmonisation pathways, public-procurement requirements, donor or prequalification expectations and every intended export market. Infrastructure resilience, imported spares, technical support and supply continuity should appear in risk, maintenance, utility and business-continuity documents.

Indian manufacturing sites

Align the quality system with the current Drugs Rules and revised Schedule M, the scope and conditions of the manufacturing licence, applicable CDSCO and State Licensing Authority requirements, pharmacopoeial obligations and the commitments of domestic and export registrations. Verify special provisions for the relevant product categories instead of assuming one generic list covers every licence.

International supply

Use the destination market and approved dossier to extend—not replace—the home-site system. PIC/S, EU, FDA, WHO-prequalification, customer and technical-agreement expectations should be mapped to responsible processes, effective documents and retrievable evidence.

Primary source framework

Requirements and guidance used for this index.

Official sources accessed 20 October 2026. Confirm current text, national adoption, licences and product commitments before implementation.

Current international baseline

Market and regional application

Draft-status discipline: The 2025 proposed revisions to EU GMP Chapter 4 and Annex 11 inform future readiness but are not represented here as final legal requirements. The operational index is anchored to current official text and established data-integrity practice.

Educational notice: This tool supports structured assessment and planning. It is not legal advice, a substitute for a site-specific risk assessment or an instruction to use documents that have not been reviewed and approved through your pharmaceutical quality system.