GMP Self-Inspection Checklist (Free Printable)

In short: This is a free, printable checklist for a GMP self-inspection of a pharmaceutical site. It covers eight areas, each with yes/no checks tied to the EU GMP Part I chapter or the 21 CFR Part 211 section that applies. Print the page, tick the answer, and write remarks for every “No”.

How to use this checklist

EU GMP Chapter 9 expects self-inspections to be carried out in order to monitor how the principles of GMP are applied and to propose corrective measures. This checklist gives your team a ready structure for that work. For the full procedure (planning, report, follow-up) see the Self-Inspection SOP.

Who should do it. Use competent, independent people, ideally from outside the area being checked. A QA person leads, with one or two reviewers from other departments. Nobody should inspect their own area.

How often. The regulations do not fix a number of days. As an example in-house criterion: cover every area at least once a year, and check high-risk areas (sterile manufacturing, QC data, deviations) twice a year or after any major change or inspection finding.

How to fill it in.

Take the page to the area. Check against the actual SOP, record or equipment, not against memory.
Mark Yes, No or NA. Write the evidence (document number, batch, equipment ID) in Remarks.
Every “No” becomes an observation. Classify it, raise a deviation or CAPA where needed, and track it to closure. See CAPA process step by step and handling incidents and deviations.
Keep the completed checklist with the self-inspection report. GMP records are kept at least 1 year after the expiry date of the respective product batch (EU GMP Chapter 4 §4.11; 21 CFR 211.180(a)), or longer if local law or the marketing authorisation requires.

The “Reference” column points to the main requirement. Adapt the questions to your own quality system and products.

1. Quality system and documentation

Check	Reference	Yes / No / NA	Remarks
Is there a documented quality policy and quality manual or equivalent, known to staff?	EU GMP Ch. 1
Is there an independent quality unit with authority to approve or reject materials and products?	EU GMP Ch. 1; 21 CFR 211.22
Are quality risk management and management review of the quality system carried out and recorded?	EU GMP Ch. 1
Are SOPs current, approved, and available at the point of use?	EU GMP Ch. 4; 21 CFR 211.100(b)
Are obsolete documents withdrawn so that only current versions are in use?	EU GMP Ch. 4
Are changes to processes, equipment or documents handled through change control?	EU GMP Ch. 1
Are batch production and control records complete, reviewed and approved before batch release?	EU GMP Ch. 4; 21 CFR 211.188, 211.192
Are records kept at least 1 year after the expiry date of the respective batch (or longer if required)?	EU GMP Ch. 4 §4.11; 21 CFR 211.180(a)
Is there a system to review product quality (annual product review) and act on its findings?	EU GMP Ch. 1; 21 CFR 211.180(e)

2. Personnel and training

Check	Reference	Yes / No / NA	Remarks
Is there an organisation chart with clear, documented responsibilities for key posts?	EU GMP Ch. 2; 21 CFR 211.25
Do production and quality heads work independently of each other?	EU GMP Ch. 2; 21 CFR 211.22
Do staff have job-specific training records, with training before they do the work?	EU GMP Ch. 2; 21 CFR 211.25(a)
Is GMP refresher training given regularly and its effectiveness checked?	EU GMP Ch. 2; 21 CFR 211.25(a)
Are staff in sterile or hazardous areas trained in the extra precautions needed there?	EU GMP Ch. 2
Are written rules on personal hygiene, illness reporting and protective clothing followed?	EU GMP Ch. 2; 21 CFR 211.28
Are eating, drinking, smoking and personal items kept out of production and storage areas?	EU GMP Ch. 2; 21 CFR 211.28
Are visitors and untrained persons escorted and recorded when entering production or QC areas?	EU GMP Ch. 2

3. Premises and equipment

Check	Reference	Yes / No / NA	Remarks
Are premises clean, in good repair and laid out to prevent mix-ups and cross-contamination?	EU GMP Ch. 3; 21 CFR 211.42
Is there a cleaning and sanitation programme with written procedures and records?	EU GMP Ch. 3; 21 CFR 211.56
Are pest-control measures in place and recorded?	EU GMP Ch. 3; 21 CFR 211.56(c)
Are HVAC, pressure differentials, temperature and humidity monitored against set limits?	EU GMP Ch. 3; 21 CFR 211.46
Is the water system monitored and results reviewed against specifications?	EU GMP Ch. 3; 21 CFR 211.48
Is equipment qualified, and are calibration and preventive maintenance done on schedule?	EU GMP Ch. 3; 21 CFR 211.67, 211.68
Are equipment cleaning and use logbooks completed at the time of use?	EU GMP Ch. 4; 21 CFR 211.182
Is equipment clearly labelled with its status (clean, in use, under maintenance)?	EU GMP Ch. 3; 21 CFR 211.105
Are measuring instruments within calibration, and are out-of-tolerance results investigated?	EU GMP Ch. 3; 21 CFR 211.68

4. Production

Check	Reference	Yes / No / NA	Remarks
Is production carried out strictly to approved master instructions?	EU GMP Ch. 5; 21 CFR 211.100
Is line clearance done and recorded before each batch and each packaging operation?	EU GMP Ch. 5; 21 CFR 211.130
Are in-process controls performed and recorded as required?	EU GMP Ch. 5; 21 CFR 211.110
Are materials weighed or measured with a second-person check where required?	EU GMP Ch. 5; 21 CFR 211.101(c)
Are intermediates and bulk products stored with correct labels and status?	EU GMP Ch. 5; 21 CFR 211.80
Are processes validated, and are changes assessed for effect on the validated state?	EU GMP Ch. 5; 21 CFR 211.100
Are yield reconciliations done and deviations investigated?	EU GMP Ch. 5; 21 CFR 211.103
Is packaging and labelling controlled, including label issue and reconciliation?	EU GMP Ch. 5; 21 CFR 211.122, 211.125
Are rejected or reprocessed materials handled under an approved procedure?	EU GMP Ch. 5; 21 CFR 211.115

5. Quality control laboratory

Check	Reference	Yes / No / NA	Remarks
Does the laboratory have approved specifications and test methods for every material and product?	EU GMP Ch. 6; 21 CFR 211.160
Are analytical methods validated or verified before routine use?	EU GMP Ch. 6; 21 CFR 211.165(e)
Are samples taken by trained staff, using a written sampling plan, and labelled correctly?	EU GMP Ch. 6; 21 CFR 211.84, 211.160
Are reference standards and reagents labelled, stored and used within their validity?	EU GMP Ch. 6; 21 CFR 211.194(c)
Are instruments calibrated and qualified, with system suitability checked where applicable?	EU GMP Ch. 6; 21 CFR 211.160(b)(4), 211.194(d)
Are out-of-specification results investigated using a written procedure?	EU GMP Ch. 6; 21 CFR 211.192
Do laboratory records include all raw data, calculations and a second-person review?	EU GMP Ch. 6; 21 CFR 211.194
Is there an ongoing stability programme with results reviewed?	EU GMP Ch. 6; 21 CFR 211.166
Are retention samples kept as required?	EU GMP Ch. 6; 21 CFR 211.170

6. Materials and warehouse

Check	Reference	Yes / No / NA	Remarks
Are materials received, checked against the order and labelled as quarantine on arrival?	EU GMP Ch. 5; 21 CFR 211.82
Are suppliers approved, and is the approved supplier list kept up to date?	EU GMP Ch. 5, Ch. 7; 21 CFR 211.84
Is a material used only after QC release?	EU GMP Ch. 5; 21 CFR 211.84
Are rejected, quarantined and released materials physically or electronically segregated?	EU GMP Ch. 5; 21 CFR 211.80
Are storage conditions (temperature, humidity, light) monitored and excursions investigated?	EU GMP Ch. 5; 21 CFR 211.142
Is stock rotated on a first-expiry-first-out basis, and are expired materials removed?	EU GMP Ch. 5; 21 CFR 211.86
Are stock records accurate when cycle-counted against physical stock?	EU GMP Ch. 4, Ch. 5
Are finished goods released only by the authorised person or quality unit, and distribution records kept?	EU GMP Ch. 1; 21 CFR 211.150
Are outsourced activities covered by a written quality agreement?	EU GMP Ch. 7

7. Complaints, recalls, deviations and CAPA

Check	Reference	Yes / No / NA	Remarks
Is there a written procedure for handling product complaints, and are complaints logged?	EU GMP Ch. 8; 21 CFR 211.198
Is each complaint investigated and the investigation documented, including batch checks?	EU GMP Ch. 8; 21 CFR 211.198(b)
Is there a recall procedure, and has it been tested (for example a mock recall)?	EU GMP Ch. 8
Are deviations recorded when they happen, assessed for impact, and approved by QA?	EU GMP Ch. 1, Ch. 5
Are root causes determined, not just “human error”, for significant deviations?	EU GMP Ch. 1
Are corrective and preventive actions assigned with owners and due dates?	EU GMP Ch. 1
Is CAPA effectiveness checked after implementation?	EU GMP Ch. 1
Are overdue deviations and CAPAs escalated to management?	EU GMP Ch. 1
Are trends in complaints, deviations and OOS results reviewed periodically?	EU GMP Ch. 1, Ch. 8
Is there a procedure for returned and salvaged products?	21 CFR 211.204, 211.208

8. Data integrity

Check	Reference	Yes / No / NA	Remarks
Are records attributable, legible, contemporaneous, original and accurate?	EU GMP Ch. 4
Do all computerised systems have individual user IDs, with no shared logins?	EU GMP Annex 11; 21 CFR 211.68
Are user access levels defined and reviewed, and is administrator access separate from routine use?	EU GMP Annex 11
Are audit trails enabled and reviewed as part of record review?	EU GMP Annex 11; EU GMP Ch. 4
Are computerised systems validated and kept in a validated state?	EU GMP Annex 11; 21 CFR 211.68
Is data backed up and the backup restore tested?	EU GMP Annex 11; 21 CFR 211.68(b)
Are blank forms and logbooks controlled and issued by QA?	EU GMP Ch. 4
Are corrections made without hiding the original entry, with date, signature and reason?	EU GMP Ch. 4; 21 CFR 211.194(a)
Are electronic and paper records kept for the retention period (at least 1 year after batch expiry, or longer if required)?	EU GMP Ch. 4 §4.11; 21 CFR 211.180(a)

Frequently asked questions

Is a self-inspection the same as an internal audit?

In pharma the terms are close. EU GMP Chapter 9 uses “self-inspection” for an examination of your own site against GMP. Many companies run it as an internal audit with the same method. What matters is that it is planned, independent, recorded and followed up.

Who should sign the completed checklist?

The inspectors who performed it sign and date it, and QA reviews it. The head of the inspected area acknowledges the observations. Follow your own SOP for the exact sign-off.

What do we do with a “No” answer?

Describe the gap in Remarks, assess its risk, and raise a deviation or CAPA where it affects product quality or compliance. Set an owner and a due date, and verify closure at the next inspection.

References

European Commission, EudraLex Volume 4, EU GMP Part I, Chapters 1 to 9 (Chapter 9: Self Inspection; Chapter 4: Documentation, §4.11 retention).
European Commission, EudraLex Volume 4, Annex 11: Computerised Systems.
US FDA, 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, Subparts A to K (eCFR).