Back to Frameworks
ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
International (ICH regions and adopting regulators)
vICH Q7 Step 4 guideline of 10 November 2000 (current; EMA reference CPMP/ICH/4106/00); the ICH Q7 Questions and Answers (2015) are explanatory and not built
9 domains
71 controls
ICH Q7, the international GMP guideline for active pharmaceutical ingredients: the independent quality unit and batch release, personnel, facilities and equipment, computerised systems, documentation and batch records, materials and supplier qualification, production and in-process controls, labelling, storage and distribution, laboratory controls, stability and reserve samples, validation, change control, rework, complaints and recalls, contract manufacturers, distributors and brokers, biotech APIs and clinical trial APIs.
Verified
ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients is a compliance framework from International (ICH regions and adopting regulators) with 9 domains and 71 controls. The largest domains are Sections 3 to 5: personnel, buildings and facilities, process equipment and computerised systems – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (13 controls), Sections 7 to 10: materials management, production and in-process controls, packaging and labelling, storage and distribution – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (13 controls), Sections 14 to 17: rejection and re-use, complaints and recalls, contract manufacturers, agents, brokers, traders and distributors – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (10 controls). Every control below carries what it requires and what an assessor expects to see.
Maintained by Gerard Blokdyk
Framework summaries on this platform are interpretations grounded in the published source, for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (9)
Introduction, scope and the API starting material – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
1 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::1.3-start | Designate and justify the point at which API production begins (the API starting material) and apply GMP from that step onward, with stringency rising towards final steps |
Section 11: laboratory controls, certificates of analysis, stability and reserve samples – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
6 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::11.1 | Give the quality unit adequate laboratories, documented sampling and test procedures, scientifically sound quality-approved specifications consistent with the filing, OOS investigation and controlled reagents and reference standards |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::11.2 | Test each batch of intermediate and API for conformance, establish and periodically compare an impurity profile for each API, and run microbiological tests where microbial quality is specified |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::11.4 | Issue authentic, signed certificates of analysis on request that show the product, batch, release date, dating, each test with limits and numerical results, and the original manufacturer |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::11.5 | Run a documented, ongoing stability programme with validated stability-indicating methods to confirm storage conditions and retest or expiry dates |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::11.6 | Base API expiry or retest dates on stability data (pilot batches allowed for preliminary dates when representative) and support dating of intermediates shipped outside the company |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::11.7 | Retain identified reserve samples of each API batch for the required period, in equivalent or more protective packaging and in enough quantity for two full analyses |
Section 2: quality management, the quality unit, internal audits and product quality review – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
5 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::2.1 | Run an effective, documented quality management system with management involvement and an independent quality unit covering both QA and QC |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::2.2 | Keep the quality unit involved in every quality matter and assign it, in writing and without delegation, the core release, approval and oversight responsibilities |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::2.3 | Define production's responsibilities in writing, from approved instructions and completed batch records to deviation reporting, clean facilities, calibration, maintenance and qualification |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::2.4 | Perform scheduled internal audits (self-inspections) of GMP compliance, report findings to management and close corrective actions on time |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::2.5 | Conduct and document a product quality review of each API, normally every year, and act on what it shows |
Section 6: documentation and records – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
7 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::6.1 | Control GMP documents through their life cycle, specify retention periods and keep production, control and distribution records for the minimum times |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::6.2 | Keep equipment use, cleaning, sanitisation, sterilisation and maintenance logs that identify the date, product, batch and person |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::6.3 | Record receipt, testing, use and disposition of raw materials, intermediates, labels and packaging materials, and keep master labels for comparison |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::6.4 | Prepare master production instructions for each intermediate and API, signed by one person and independently checked and signed by the quality unit, with the full content set |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::6.5 | Issue a checked, uniquely numbered batch production record for each batch, document each significant step, and investigate critical deviations and failures across related batches |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::6.6 | Keep complete laboratory control records: samples, methods, weights, raw data, calculations, results against criteria, analyst signature and second-person review |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::6.7 | Review and approve batch production and laboratory records, including all deviation, investigation and OOS reports, before release; the quality unit reviews critical steps |
Sections 12 and 13: validation and change control – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
7 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::12.1-12.2 | Document a validation policy, identify critical parameters and attributes, and validate critical operations under quality-approved protocols and reports that address deviations |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::12.3 | Complete design, installation, operational and performance qualification of critical equipment and ancillary systems before process validation |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::12.4-12.5 | Validate API processes, normally prospectively before commercial distribution of the medicine, using concurrent or retrospective approaches only where their conditions are met, with justified run numbers and controlled critical parameters |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::12.6 | Periodically evaluate validated systems and processes to confirm they remain in a validated state |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::12.7 | Validate cleaning procedures where carry-over poses the greatest risk, with representative worst-case selection, a full protocol, suitable sampling and validated sensitive methods, and monitor cleaning effectiveness afterwards |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::12.8 | Validate analytical methods (or verify compendial ones under actual use) per the ICH validation guidelines, qualify analytical equipment first and record any method modification with supporting data |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::13 | Operate a formal change control system: quality unit approval, impact evaluation and classification, document updates, evaluation of first batches, stability impact and notification of dosage form manufacturers |
Sections 14 to 17: rejection and re-use, complaints and recalls, contract manufacturers, agents, brokers, traders and distributors – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
10 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::14.1-14.2 | Quarantine and record the disposition of out-of-specification material, and reprocess only by repeating established steps, building routine reprocessing into the process and evaluating any repeated reaction |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::14.3 | Investigate non-conformance before reworking, then show reworked batches are of equivalent quality by evaluation, testing, stability where warranted and impurity profile comparison |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::14.4 | Recover reactants, intermediates, APIs and solvents only under approved, controlled and monitored procedures with documented use and proven suitability |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::14.5 | Quarantine returned intermediates and APIs, reprocess, rework or destroy them where storage or container condition casts doubt, and record each return |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::15 | Record and investigate all quality complaints under a written procedure, trend them, keep a recall procedure, and inform authorities in serious or life-threatening situations |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::16 | Evaluate contract manufacturers and laboratories for GMP, set written GMP responsibilities with audit rights, control subcontracting and changes, and keep records at the contract site |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::17.1-17.3 | Agents, brokers, traders, distributors, repackers and relabellers comply with GMP, operate a quality system and keep complete traceability documents for every API and intermediate they handle |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::17.4-17.5 | Repack, relabel and hold APIs under GMP controls and suitable environmental conditions, and run stability studies when repacking into a different container type |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::17.6 | Pass all quality and regulatory information between the manufacturer and the customer, name the original manufacturer and batch, disclose the manufacturer to authorities on request and meet the certificate of analysis rules |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::17.7-17.8 | Distributors and repackers record complaints and recalls, review them with the original manufacturer where warranted, keep the manufacturer's responses, and handle and document returns |
Sections 18 and 19: cell culture and fermentation APIs, and APIs for clinical trials – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::18.1 | Control every stage of cell culture and fermentation APIs: appropriate prior steps, environmental controls matched to open or closed processing, process controls for cell banks, culture, harvest, bioburden and viral safety, and demonstrated impurity removal |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::18.2 | Restrict access to cell banks, store them to keep viability and prevent contamination, record vial use and storage and monitor suitability |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::18.3 | Use closed systems or controlled environments for aseptic additions and open manipulations, monitor critical culture parameters, clean and sterilise equipment and media, and detect, assess and record contamination |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::18.4 | Harvest and purify in equipment and areas that minimise contamination, with procedures that consistently remove the organism, debris and media, clean equipment after use and add controls for multi-product use |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::18.5 | Run viral removal and inactivation steps within validated parameters and prevent virus carry-over by segregation, separate air handling and cleaning |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::19.1-19.3 | Manufacture clinical trial APIs in suitable facilities with stage-appropriate GMP, an independent quality unit approving each batch, material testing, problem evaluation, investigational labelling and clean, calibrated equipment |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::19.4-19.5 | Evaluate raw materials for clinical APIs by testing or supplier analysis with identity testing, and document production in notebooks or batch records |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::19.6-19.7 | Validate processes per section 12 once batches are for commercial use, even at pilot scale, and record every change to production, specifications or test procedures during development |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::19.8-19.9 | Use scientifically sound methods for clinical batches, retain reserve samples and records for an appropriate period after the application ends, apply dating rules to existing APIs and document development knowledge |
Sections 3 to 5: personnel, buildings and facilities, process equipment and computerised systems – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
13 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::3.1 | Staff manufacture with enough qualified people, written responsibilities and regular, recorded, periodically assessed GMP training |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::3.2 | Enforce personnel hygiene: suitable clean clothing and protective wear, no direct contact with product, food and smoking kept to set areas, and exclusion of ill workers |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::3.3 | Use only suitably qualified consultants and keep records of their name, address, qualifications and service |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::4.1 | Design buildings and material and people flows to ease cleaning and maintenance, prevent mix-ups and contamination, and provide defined areas for each activity |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::4.2 | Qualify and monitor utilities that can affect product (steam, gases, compressed air, HVAC), control air handling and recirculation, identify pipework and protect drains |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::4.3 | Show process water is fit for use (at least drinking-water quality unless justified), set tighter specifications where needed and validate any in-house treatment |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::4.4 | Use dedicated production areas for highly sensitising materials such as penicillins and cephalosporins, consider them for highly potent or infectious materials, and keep toxic non-pharmaceuticals out |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::4.5-4.6 | Provide adequate lighting in all areas and dispose of sewage, refuse and process waste safely, promptly and hygienically in identified containers |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::4.7 | Keep buildings maintained, repaired and clean under written sanitation procedures, including controlled use of pest control agents and cleaning chemicals |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::5.1 | Design, build, identify and use process equipment so it suits its purpose, does not alter product, stays within its qualified range and has current drawings |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::5.2 | Maintain equipment preventively and clean it under detailed written procedures with justified residue limits, status labelling and controls against carry-over |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::5.3 | Calibrate critical control, weighing, measuring, monitoring and test equipment to a written schedule against traceable standards, and investigate out-of-calibration findings |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::5.4 | Validate GMP computerised systems and control access, data changes, data entry, incidents, changes, backup and data protection |
Sections 7 to 10: materials management, production and in-process controls, packaging and labelling, storage and distribution – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
13 controls
| Code | Title |
|---|---|
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::10.1-10.2 | Store materials under recorded appropriate conditions with segregated quarantine, rejected, returned and recalled stock, distribute only quality-released product, control transport and keep distribution records that allow recall |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::7.1 | Govern materials under written procedures and buy critical materials against agreed specifications from quality-approved suppliers whose actual manufacturer is known |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::7.2 | Inspect each incoming container, quarantine materials until released, prevent wrong discharge into existing stock, assure tanker cleanliness and give every lot a distinctive code and status |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::7.3 | Test at least identity on each incoming batch, rely on supplier certificates only after supplier qualification with periodic full testing, justify exemptions and sample representatively |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::7.4-7.5 | Store materials to prevent degradation and contamination, off the floor, oldest first, with rejected stock quarantined, and re-evaluate materials after prolonged storage or exposure |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::8.1 | Weigh and subdivide materials accurately into identified containers, witness critical operations, compare actual and expected yields, investigate deviations and show equipment processing status |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::8.2 | Meet time limits set in the master instructions, document and evaluate deviations, and hold intermediates under suitable conditions |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::8.3 | Define and approve in-process controls and sampling procedures, record all results in the batch record and protect in-process sample integrity |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::8.4 | Blend only batches that individually meet specification, never to rescue out-of-specification batches; control, document, trace, validate where attributes are critical and date by the oldest component |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::8.5 | Control carry-over of residues between successive batches and prevent contamination of intermediates and APIs, especially after purification |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::9.1-9.2 | Control receipt, testing and release of packaging and labelling materials, reject non-conforming ones, and use clean, non-reactive containers that protect the product |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::9.3 | Restrict access to labels, reconcile labels issued, used and returned, destroy excess and obsolete labels, control printing devices and keep a representative label in the batch record |
| ich-q7-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients::9.4 | Run packaging and labelling to prevent mix-ups, label containers with the required identity, batch, storage, manufacturer and dating information, line-clear before use, check labelled packs and apply tamper-evident seals |
What is ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients and who does it apply to?
ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients is a compliance framework from International (ICH regions and adopting regulators) with 9 domains and 71 controls. ICH Q7, the international GMP guideline for active pharmaceutical ingredients: the independent quality unit and batch release, personnel, facilities and equipment, computerised systems, documentation and batch records, materials and supplier qualification, production and in-process controls, labelling, storage and distribution, laboratory controls, stability and reserve samples, validation, change control, rework, complaints and recalls, contract manufacturers, distributors and brokers, biotech APIs and clinical trial APIs. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients actually require?
ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients has 71 controls organised across 9 domains. The largest domains are Sections 3 to 5: personnel, buildings and facilities, process equipment and computerised systems – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (13 controls), Sections 7 to 10: materials management, production and in-process controls, packaging and labelling, storage and distribution – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (13 controls), Sections 14 to 17: rejection and re-use, complaints and recalls, contract manufacturers, agents, brokers, traders and distributors – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (10 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients do I already cover?
ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients?
Start your ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 71 controls and track your progress.
Start Your Compliance Journey
Create a free account to run self-assessments, get AI advisory, and track your compliance progress across 1,111 frameworks.
Get Started Free →Free forever, no credit card required