Quality Assurance & SOPs
The pharmaceutical quality system (ICH Q10), quality risk management tools (ICH Q9(R1)), the key GMP references, and the master list of GMP procedures a manufacturing site requires, by department.
Four PQS elements applied across the product lifecycle, supported by two enablers.
Process performance and product quality monitoring
Trending of CQAs, CPPs, in-process controls, stability and complaints to keep the process in a state of control.
Corrective and preventive action (CAPA)
Root cause investigation of deviations, complaints, OOS results and audit findings, with a check of effectiveness.
Change management
Risk-based evaluation, approval and post-implementation review of every change, including its regulatory impact.
Management review
Periodic review of process performance, product quality and PQS effectiveness by senior management.
Knowledge management
Capturing development, technology transfer and manufacturing knowledge so decisions rest on current product understanding.
Quality risk management (ICH Q9(R1))
Systematic assessment, control, communication and review of risks to quality, with formality proportional to the risk.
Tools listed in ICH Q9(R1), Annex I, and where each fits best.
| Tool | Typical use | How it works |
|---|---|---|
| FMEA | Process and equipment failure modes | Each failure mode is scored for severity, occurrence and detectability; RPN = S × O × D ranks the risks. |
| FMECA | Critical process steps and product design | FMEA extended with a criticality analysis of each failure mode. |
| FTA | Root cause of complex failures and complaints | A top event is broken down into its causes with AND/OR logic gates. |
| HACCP | Microbiological, chemical and physical hazards | Seven principles: hazard analysis, critical control points, critical limits, monitoring, corrective action, verification, records. |
| HAZOP | Facilities, utilities and equipment design | Guide words (no, more, less, reverse…) applied to each design parameter to find deviations from intent. |
| PHA | Early development, when little is known | Hazards are listed and ranked by severity and likelihood. |
| Risk ranking and filtering | Prioritising sites, suppliers or products | Weighted scoring of several risk factors to compare and filter many items. |
| Reference | Subject |
|---|---|
| PIC/S PE 009 | PIC/S GMP Guide: Part I, Part II (APIs) and annexes |
| EudraLex Vol. 4 | EU GMP guidelines |
| 21 CFR 210 / 211 | US current GMP for finished pharmaceuticals |
| WHO TRS 986, Annex 2 | WHO GMP: main principles |
| ICH Q7 | GMP for active pharmaceutical ingredients |
| ICH Q9(R1) / Q10 | Quality risk management; pharmaceutical quality system |
| Annex 1 (2022) | Manufacture of sterile medicinal products |
| Annex 11 | Computerised systems |
| Annex 15 | Qualification and validation |
| PIC/S PI 041 | Data management and integrity |
Each row gives the SOP title and its required scope.
The full text of all 145 SOPs is ready (in Persian): press “Full text” on a row.
145 of 145 SOPs
| Code | SOP title | Required scope | Department |
|---|---|---|---|
| QA-001 | Preparation, approval and revision of SOPsFull text | Format, numbering, review period, controlled copies | Quality Assurance |
| QA-002 | Document and record controlFull text | Issue, distribution, retention, archiving, destruction | Quality Assurance |
| QA-003 | Good documentation practiceFull text | Entries, corrections, signatures, ALCOA principles | Quality Assurance |
| QA-004 | Data integrityFull text | Access control, audit trail review, backup and restore | Quality Assurance |
| QA-005 | Change controlFull text | Request, impact assessment, approval, implementation, closure | Quality Assurance |
| QA-006 | Deviation managementFull text | Reporting, classification, investigation, closure | Quality Assurance |
| QA-007 | Corrective and preventive action (CAPA)Full text | Root cause analysis, action plan, effectiveness check | Quality Assurance |
| QA-008 | Quality risk managementFull text | Risk assessment tools, risk register, periodic review | Quality Assurance |
| QA-009 | Complaint handlingFull text | Receipt, investigation, reply, trending | Quality Assurance |
| QA-010 | Product recallFull text | Classification, decision, notification, mock recall | Quality Assurance |
| QA-011 | Returned productsFull text | Receipt, quarantine, evaluation, disposition | Quality Assurance |
| QA-012 | Batch record review and batch releaseFull text | Manufacturing and packaging records, test results, release decision | Quality Assurance |
| QA-013 | Batch numbering and expiry datingFull text | Numbering system, manufacturing and expiry date rules | Quality Assurance |
| QA-014 | Product quality reviewFull text | Data collection, trend analysis, conclusions, actions | Quality Assurance |
| QA-015 | Self-inspectionFull text | Schedule, checklist, report, follow-up | Quality Assurance |
| QA-016 | Supplier qualification and auditFull text | Questionnaire, audit, approved supplier list, re-evaluation | Quality Assurance |
| QA-017 | Contract manufacture and analysisFull text | Quality agreement, responsibilities, oversight | Quality Assurance |
| QA-018 | Training and qualification of personnelFull text | Training matrix, GMP induction, assessment, records | Quality Assurance |
| QA-019 | Validation master planFull text | Scope, responsibilities, schedule, revalidation policy | Quality Assurance |
| QA-020 | Process validationFull text | Protocol, validation batches, sampling plan, report | Quality Assurance |
| QA-021 | Cleaning validationFull text | Worst-case product, residue limits, swab and rinse sampling | Quality Assurance |
| QA-022 | Equipment qualificationFull text | DQ, IQ, OQ and PQ protocols and reports | Quality Assurance |
| QA-023 | Computerised system validationFull text | User requirements, testing, access levels, periodic review | Quality Assurance |
| QA-024 | Line clearanceFull text | Checks before starting manufacture or packaging | Quality Assurance |
| QA-025 | In-process quality assuranceFull text | Shop-floor checks, sampling, record verification | Quality Assurance |
| QA-026 | Rejected materials and productsFull text | Identification, segregation, destruction records | Quality Assurance |
| QA-027 | Reprocessing and reworkingFull text | Justification, approval, additional testing | Quality Assurance |
| QA-028 | Label and artwork controlFull text | Artwork approval, version control, obsolete versions | Quality Assurance |
| QA-029 | Ongoing stability programmeFull text | Batch selection, protocol, trending, reporting | Quality Assurance |
| QA-030 | Handling of regulatory inspectionsFull text | Preparation, hosting, response to observations | Quality Assurance |
| QA-031 | Management reviewFull text | Quality indicators, inputs, decisions, follow-up | Quality Assurance |
| QA-032 | Quality manual and pharmaceutical quality system (ICH Q10)Full text | Quality policy and objectives, PQS elements and enablers, performance indicators, management responsibility | Quality Assurance |
| QA-033 | Site master fileFull text | Content per PIC/S PE 008, annexes (layouts, water and HVAC schematics), review and update | Quality Assurance |
| QA-034 | Investigation and root cause analysisFull text | Problem statement, Ishikawa diagram, 5 Whys, fault tree analysis, human-error assessment, effectiveness check | Quality Assurance |
| QA-035 | Health-based exposure limits and cross-contamination risk assessmentFull text | PDE derivation, toxicological assessment, MACO for cleaning limits, decision on shared facilities | Quality Assurance |
| QA-036 | Nitrosamine impurity risk assessmentFull text | Three-step process, sources of risk, CPCA and acceptable intake, confirmatory testing, control strategy | Quality Assurance |
| QA-037 | Elemental impurities risk assessment (ICH Q3D)Full text | Element classes, PDEs by route, potential sources, 30% control threshold, option 1 and option 2 calculations | Quality Assurance |
| QA-038 | Continued process verification (stage 3)Full text | CPV plan, trending of CQAs and CPPs, control charts, capability indices, response to signals, periodic report | Quality Assurance |
| QA-039 | Audit trail reviewFull text | Risk-based scope, review frequency, critical events, review before result approval, documentation of findings | Quality Assurance |
| QA-040 | Contamination control strategy (Annex 1)Full text | Scope of the CCS, elements required by Annex 1, risk assessment, review of monitoring data, periodic update | Quality Assurance |
| QC-001 | Sampling of raw materialsFull text | Sampling plan, sampling booth, tools, labelling | Quality Control laboratory |
| QC-002 | Sampling of packaging materialsFull text | Sampling plan, defect classes, acceptance levels | Quality Control laboratory |
| QC-003 | Sampling of in-process and finished productsFull text | Sample size, points, handling | Quality Control laboratory |
| QC-004 | Receipt and registration of samplesFull text | Logbook, numbering, storage before testing | Quality Control laboratory |
| QC-005 | Testing and release of raw materialsFull text | Specification, testing, result review, status label | Quality Control laboratory |
| QC-006 | Testing and release of packaging materialsFull text | Visual, dimensional and functional checks | Quality Control laboratory |
| QC-007 | Testing of finished productsFull text | Specification, test record, certificate of analysis | Quality Control laboratory |
| QC-008 | Out-of-specification resultsFull text | Laboratory investigation, full investigation, retest rules | Quality Control laboratory |
| QC-009 | Out-of-trend resultsFull text | Trend limits, detection, investigation | Quality Control laboratory |
| QC-010 | Analytical method validationFull text | Specificity, accuracy, precision, linearity, range, robustness | Quality Control laboratory |
| QC-011 | Analytical method transfer and verificationFull text | Protocol, comparative testing, acceptance criteria | Quality Control laboratory |
| QC-012 | Reference and working standardsFull text | Receipt, qualification, storage, use log | Quality Control laboratory |
| QC-013 | Reagents, volumetric solutions and mobile phasesFull text | Preparation, standardisation, labelling, expiry | Quality Control laboratory |
| QC-014 | Calibration of laboratory instrumentsFull text | Schedule, tolerances, out-of-calibration handling | Quality Control laboratory |
| QC-015 | Analytical balanceFull text | Operation, daily check, calibration | Quality Control laboratory |
| QC-016 | pH meterFull text | Operation, buffer calibration, electrode care | Quality Control laboratory |
| QC-017 | HPLC systemFull text | Operation, system suitability, column log, calibration | Quality Control laboratory |
| QC-018 | UV-visible spectrophotometerFull text | Operation, wavelength and absorbance checks | Quality Control laboratory |
| QC-019 | Dissolution testerFull text | Operation, mechanical calibration, performance check | Quality Control laboratory |
| QC-020 | Karl Fischer titratorFull text | Operation, titrant standardisation | Quality Control laboratory |
| QC-021 | Laboratory records and raw dataFull text | Worksheets, notebooks, review, archiving | Quality Control laboratory |
| QC-022 | Conduct of stability studiesFull text | Protocol, storage, pull schedule, testing, report | Quality Control laboratory |
| QC-023 | Stability chambersFull text | Monitoring, alarms, excursion handling | Quality Control laboratory |
| QC-024 | Retention samplesFull text | Quantity, storage, retention period, inspection | Quality Control laboratory |
| QC-025 | Purified water testingFull text | Sampling points, chemical tests, alert and action limits | Quality Control laboratory |
| QC-026 | Glassware cleaningFull text | Washing, rinsing, drying, storage | Quality Control laboratory |
| QC-027 | Laboratory safety and chemical wasteFull text | Protective equipment, spills, waste segregation | Quality Control laboratory |
| MIC-001 | Environmental monitoring of clean areasFull text | Settle plates, air and surface sampling, personnel, limits | Microbiology |
| MIC-002 | Microbial limit testFull text | Total counts, specified organisms, method suitability | Microbiology |
| MIC-003 | Sterility testFull text | Membrane filtration, direct inoculation, incubation | Microbiology |
| MIC-004 | Bacterial endotoxin testFull text | LAL method, inhibition and enhancement test | Microbiology |
| MIC-005 | Preservative efficacy testFull text | Challenge organisms, sampling intervals, criteria | Microbiology |
| MIC-006 | Culture media preparation and growth promotionFull text | Preparation, sterilisation, growth promotion, storage | Microbiology |
| MIC-007 | Reference culturesFull text | Receipt, subculture, passage limit, storage | Microbiology |
| MIC-008 | Microbiological testing of waterFull text | Sampling, membrane filtration, limits | Microbiology |
| MIC-009 | DisinfectantsFull text | Preparation, rotation, efficacy verification | Microbiology |
| MIC-010 | Laboratory autoclaveFull text | Loading patterns, cycle, biological indicators | Microbiology |
| MIC-011 | Microbiology laboratory gowning and aseptic techniqueFull text | Gowning steps, laminar flow cabinet use | Microbiology |
| PRD-001 | Dispensing of raw materialsFull text | Balance check, weighing, double check, labelling | Production |
| PRD-002 | Batch manufacturing recordFull text | Issue, completion, corrections, return to QA | Production |
| PRD-003 | Gowning and entry to production areasFull text | Changing rooms, garments, entry and exit sequence | Production |
| PRD-004 | Personnel hygiene and healthFull text | Hand washing, illness reporting, medical checks | Production |
| PRD-005 | Cleaning and sanitisation of production areasFull text | Frequency, agents, method, records | Production |
| PRD-006 | Equipment cleaning and status labellingFull text | Cleaning levels, clean hold time, status labels | Production |
| PRD-007 | Product changeoverFull text | Line clearance, cleaning verification, documentation | Production |
| PRD-008 | Sifting and millingFull text | Sieve integrity check, operation, cleaning | Production |
| PRD-009 | High-shear granulatorFull text | Operation, process parameters, cleaning | Production |
| PRD-010 | Fluid bed dryerFull text | Operation, drying end point, filter bag care | Production |
| PRD-011 | BlenderFull text | Loading, blending time, discharge, cleaning | Production |
| PRD-012 | Tablet pressFull text | Set-up, start-up checks, in-process controls, cleaning | Production |
| PRD-013 | Punches and diesFull text | Receipt, inspection, storage, usage log | Production |
| PRD-014 | Tablet coatingFull text | Suspension preparation, parameters, weight gain | Production |
| PRD-015 | Capsule filling machineFull text | Set-up, weight control, polishing, cleaning | Production |
| PRD-016 | Manufacturing vessel and homogeniserFull text | Semi-solid and liquid manufacture, parameters, cleaning | Production |
| PRD-017 | Liquid filling and cappingFull text | Fill volume control, torque, cleaning | Production |
| PRD-018 | Tube filling and sealingFull text | Fill weight, seal quality, coding | Production |
| PRD-019 | Blister packagingFull text | Forming, sealing, leak test, coding | Production |
| PRD-020 | Secondary packaging and reconciliationFull text | Printed material control, reconciliation, coding check | Production |
| PRD-021 | In-process controlsFull text | Tests, frequency, limits, action on failure | Production |
| PRD-022 | Yield calculation and reconciliationFull text | Theoretical and actual yield, limits, investigation | Production |
| PRD-023 | Intermediate and bulk productsFull text | Containers, labelling, storage, hold time | Production |
| PRD-024 | Metal detectionFull text | Challenge test, frequency, rejected units | Production |
| PRD-025 | Production wasteFull text | Collection, recording, destruction | Production |
| PRD-026 | Aseptic fillingFull text | Set-up, interventions, environmental monitoring | Production |
| PRD-027 | Aseptic process simulationFull text | Design, frequency, incubation, acceptance criteria | Production |
| PRD-028 | Steam sterilisationFull text | Load patterns, cycle parameters, records | Production |
| PRD-029 | DepyrogenationFull text | Tunnel or oven operation, temperature records | Production |
| PRD-030 | Filter integrity testingFull text | Bubble point test before and after filtration | Production |
| WHS-001 | Receipt of materialsFull text | Delivery check, documents, cleaning of containers, registration | Warehouse |
| WHS-002 | Quarantine and status labellingFull text | Quarantine, released and rejected status | Warehouse |
| WHS-003 | Storage of materials and productsFull text | Storage conditions, segregation, housekeeping | Warehouse |
| WHS-004 | Temperature and humidity monitoring and mappingFull text | Data loggers, mapping study, excursions | Warehouse |
| WHS-005 | Issue of materials to productionFull text | First-expired first-out, requisition, records | Warehouse |
| WHS-006 | Printed packaging materialsFull text | Secure storage, counting, issue, returns | Warehouse |
| WHS-007 | Damaged and non-conforming deliveriesFull text | Segregation, notification, disposition | Warehouse |
| WHS-008 | Retest of materialsFull text | Retest date tracking, resampling request | Warehouse |
| WHS-009 | Finished product storage and dispatchFull text | Release check, picking, dispatch records | Warehouse |
| WHS-010 | Distribution and transportFull text | Vehicle checks, cold chain, traceability | Warehouse |
| WHS-011 | Stock count and reconciliationFull text | Periodic count, discrepancies, investigation | Warehouse |
| ENG-001 | Preventive maintenanceFull text | Schedule, checklists, records | Engineering and utilities |
| ENG-002 | Breakdown maintenanceFull text | Request, repair, release back to use | Engineering and utilities |
| ENG-003 | Calibration programmeFull text | Master list, intervals, traceable standards, labels | Engineering and utilities |
| ENG-004 | HVAC systemFull text | Operation, pressure differentials, filter integrity test | Engineering and utilities |
| ENG-005 | Purified water systemFull text | Operation, sanitisation, monitoring | Engineering and utilities |
| ENG-006 | Compressed air and process gasesFull text | Quality tests, filters, monitoring | Engineering and utilities |
| ENG-007 | Pest controlFull text | Bait map, inspection frequency, records | Engineering and utilities |
| ENG-008 | Equipment logbooksFull text | Use, cleaning and maintenance entries | Engineering and utilities |
| ENG-009 | LubricantsFull text | Approved grades, product-contact risk | Engineering and utilities |
| ENG-010 | Building and facility upkeepFull text | Surfaces, drains, lighting, repairs | Engineering and utilities |
| ENG-011 | Power failure and emergenciesFull text | Actions, product impact assessment, restart | Engineering and utilities |
| RND-001 | Product development planningFull text | Target product profile, critical quality attributes, stages | Research and Development |
| RND-002 | Reference product evaluationFull text | Characterisation, composition, dissolution profile | Research and Development |
| RND-003 | Pre-formulation studiesFull text | Solubility, particle size, polymorphism, stability | Research and Development |
| RND-004 | Drug and excipient compatibility studiesFull text | Binary mixtures, stress conditions, evaluation | Research and Development |
| RND-005 | Formulation trials and laboratory notebooksFull text | Trial numbering, recording, review | Research and Development |
| RND-006 | Laboratory batch recordsFull text | Formula, process steps, observations, results | Research and Development |
| RND-007 | Analytical method developmentFull text | Method design, forced degradation, handover for validation | Research and Development |
| RND-008 | Pilot batchesFull text | Batch size, process parameters, sampling | Research and Development |
| RND-009 | Scale-up and technology transferFull text | Transfer protocol, documents, acceptance criteria | Research and Development |
| RND-010 | Development stability studiesFull text | Conditions, time points, packaging, evaluation | Research and Development |
| RND-011 | Dissolution profile comparisonFull text | Media, time points, similarity factor f2 | Research and Development |
| RND-012 | Batches for bioequivalence studiesFull text | Batch size, documentation, retention samples | Research and Development |
| RND-013 | Pharmaceutical development reportFull text | Structure, data, link to CTD section 3.2.P.2 | Research and Development |
| RND-014 | R&D sample and material managementFull text | Receipt, labelling, storage, disposal | Research and Development |
| RND-015 | Evaluation of new raw material sourcesFull text | Documents, testing, trial batch, recommendation | Research and Development |
Codes are suggestions; each company can apply its own numbering system.
Header: title, code, revision number, effective date, next review date, prepared by, reviewed by and approved by (QA).