This is a ready-to-use gap assessment checklist built directly on the structure of 21 CFR Part 211, subpart by subpart, section by section. It is a different tool from a general facility self-inspection: it exists to answer “does a documented control exist for every numbered requirement in Part 211,” which is the right question for a new site standing up its quality system, a newly acquired facility being assessed against the parent company’s expectations, or a QA function that wants a citation-level view rather than a process-area view. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is educational reference to adapt to your own site; verify each cited section against the current regulation before you rely on it.
Assessment control
| Field | Entry |
|---|---|
| Assessment number | <<FILL: GAP-ID>> |
| Site / facility | <<FILL>> |
| Trigger | <<FILL: new site / acquisition / periodic / post-finding>> |
| Assessment team (names, roles) | <<FILL>> |
| Assessment date(s) | <<FILL>> |
| Scope (full Part 211 / named subparts only) | <<FILL>> |
Mark each item Pass (a documented, followed control exists), Fail (no control, or a control exists on paper but is not followed), or N/A, with evidence and an owner for every Fail.
Subpart A and B, general provisions and organization
| # | Item | Section | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|---|
| A.1 | Scope of the site’s cGMP program is defined and matches the products actually made (human, veterinary, OTC, prescription) | 211.1 | <<FILL>> | <<FILL>> | <<FILL>> |
| B.1 | A quality unit exists with documented, followed authority to approve or reject all materials, records, and products | 211.22 | <<FILL>> | ||
| B.2 | A written and approved procedure defines the quality unit’s own responsibilities | 211.22 | <<FILL>> | ||
| B.3 | Personnel qualification and cGMP training records exist for the operations each person performs | 211.25 | <<FILL>> | ||
| B.4 | Personnel hygiene, clothing, and restricted-access controls are documented and enforced | 211.28 | <<FILL>> | ||
| B.5 | Any consultant performing a cGMP function has documented qualifications on file | 211.34 | <<FILL>> |
Subpart C and D, facilities and equipment
| # | Item | Section | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|---|
| C.1 | Building design provides defined areas or other control systems to prevent contamination and mix-ups | 211.42 | <<FILL>> | <<FILL>> | <<FILL>> |
| C.2 | Ventilation, air filtration, and pressure differentials are controlled and monitored where relevant to the product | 211.46 | <<FILL>> | ||
| C.3 | Written cleaning, sanitation, and pest-control procedures exist and are followed | 211.56 | <<FILL>> | ||
| D.1 | Equipment is suitably designed, sized, and located for cleaning, maintenance, and proper operation | 211.63 | <<FILL>> | ||
| D.2 | Written equipment cleaning and maintenance procedures exist, with cleaning and use records | 211.67 | <<FILL>> | ||
| D.3 | Automated and computerized systems have documented calibration, access controls, and a secure backup | 211.68 | <<FILL>> |
Subpart E, components, containers, and closures
| # | Item | Section | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|---|
| E.1 | Written procedures cover receipt, sampling, testing, and approval or rejection of components | 211.80 | <<FILL>> | <<FILL>> | <<FILL>> |
| E.2 | Incoming components are quarantined until sampled, tested, and released | 211.82 | <<FILL>> | ||
| E.3 | At least one identity test is performed in-house on every lot of each component | 211.84 | <<FILL>> | ||
| E.4 | Supplier certificates of analysis are accepted only where supplier reliability is established and periodically re-verified | 211.84 | <<FILL>> | ||
| E.5 | Rejected components are identified and physically or system-controlled to prevent use | 211.89 | <<FILL>> |
Subpart F, production and process controls
| # | Item | Section | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|---|
| F.1 | Written production and process control procedures exist, are followed, and any deviation is recorded and justified | 211.100 | <<FILL>> | <<FILL>> | <<FILL>> |
| F.2 | Component charge-in includes a documented second-person verification of identity and weight | 211.101 | <<FILL>> | ||
| F.3 | Yield calculations are performed and independently verified at each appropriate phase | 211.103 | <<FILL>> | ||
| F.4 | In-process specifications are derived from process data, not set arbitrarily | 211.110 | <<FILL>> | ||
| F.5 | Sterilization and other processes assuring microbiological control are validated | 211.113 | <<FILL>> |
Subpart G and H, packaging, labeling, holding, and distribution
| # | Item | Section | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|---|
| G.1 | Labeling is reconciled (issued, used, destroyed) with discrepancies investigated | 211.125 | <<FILL>> | <<FILL>> | <<FILL>> |
| G.2 | Line clearance is documented before and after each packaging or labeling operation | 211.130 | <<FILL>> | ||
| G.3 | Expiration dating on the label is supported by a stability program | 211.137 | <<FILL>> | ||
| H.1 | Warehousing procedures assure appropriate storage conditions and quarantine before release | 211.142 | <<FILL>> | ||
| H.2 | Distribution records allow a lot to be traced to permit a recall, and stock rotation is enforced | 211.150 | <<FILL>> |
Subpart I, laboratory controls
| # | Item | Section | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|---|
| I.1 | Laboratory specifications, sampling plans, and test methods are documented, approved, and followed | 211.160 | <<FILL>> | <<FILL>> | <<FILL>> |
| I.2 | Each batch is tested for identity and strength of each active ingredient before release | 211.165 | <<FILL>> | ||
| I.3 | A written stability program supports the expiration dating strategy | 211.166 | <<FILL>> | ||
| I.4 | Reserve samples are retained in the marketed container-closure and examined at least annually | 211.170 | <<FILL>> | ||
| I.5 | Out-of-specification results are investigated per a documented, followed OOS procedure | 211.192 (with FDA OOS guidance) | <<FILL>> |
Subpart J and K, records and returns
| # | Item | Section | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|---|
| J.1 | A current, approved master production and control record exists for every product, with preparer and independent-checker signatures | 211.186 | <<FILL>> | <<FILL>> | <<FILL>> |
| J.2 | Executed batch records are reviewed and approved by the quality unit before release, with every unexplained discrepancy investigated and the investigation extended to other batches | 211.192 | <<FILL>> | ||
| J.3 | Laboratory records include the complete raw data set and a second-person review for accuracy and completeness | 211.194 | <<FILL>> | ||
| J.4 | Complaint records exist for every complaint, with a documented decision on whether a 211.192 investigation is warranted | 211.198 | <<FILL>> | ||
| K.1 | Returned or salvaged product is held and not returned to stock without documented evidence it meets specifications | 211.204, 211.208 | <<FILL>> |
Acceptance criteria
- Every item is Pass or a justified N/A, or carries a Fail with a named owner and a due date.
- Every Fail is routed to a CAPA or a remediation plan before the assessment is closed as complete.
- Items citing 211.68 and 211.194 (computerized systems and laboratory records) are cross-checked against the site’s audit trail review evidence, not assumed from the SOP existing.
- If the site handles medical gas products, confirm they are assessed under 21 CFR Part 213, not Part 211 (211.1(a) excludes medical gases as of the 2024 final rule, effective 18 December 2025).
- The completed assessment is signed and the open actions are tracked to closure at a defined cadence.
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Assessment lead | <<FILL>> | ||
| Quality Assurance | <<FILL>> | ||
| Site Quality Head | <<FILL>> |
References
21 CFR Part 210 and Part 211, all subparts as cited above. 21 CFR Part 213 (medical gases), where applicable. FDA guidance, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (2006, Level 2 revision May 2022). ICH Q10, Pharmaceutical Quality System.
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
A partial completed assessment for an example newly acquired oral solid dosage site. Illustrative only.
| # | Item | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|
| B.2 | Quality unit’s own procedure exists | Fail | No standalone quality unit charter SOP found; authority described only in the quality manual | J. Reyes, due 15 Oct |
| E.3 | In-house identity test on every component lot | Pass | Reviewed 20 incoming lot records, FTIR identity confirmed on each, no reliance on supplier COA for identity | - |
| F.2 | Second-person charge-in verification | Fail | Three of ten sampled batch records showed a single signature on the dispensing step | J. Reyes, due 1 Oct |
| I.5 | OOS investigations follow documented procedure | Pass | Five OOS records reviewed, each showed a phase 1 lab investigation before any phase 2 escalation | - |
| J.1 | Master production record has independent-checker signature | Fail | Two of six master records had only a preparer signature, no second signature | Site QA Head, due 1 Nov |
The pattern in this specimen is typical of a newly acquired site: the paperwork mostly exists, but independent second-person verification, the specific mechanic 211.101, 211.194, and 211.186 all build in, is the recurring gap. That is exactly the kind of finding this citation-level checklist is built to surface before an external inspector finds it.
Common inspection findings this checklist prevents
- A quality unit that operates informally, with no written procedure defining its own authority, discovered only when an inspector asks to see it.
- Second-person verification steps that exist on the batch record form but are not actually performed independently.
- A master production record missing the independent-checker signature 211.186 requires.
- Medical gas products still being assessed and documented under Part 211 after the 2024 final rule moved them to Part 213.
- A site-wide assumption that “we follow cGMP” without a citation-level record of which section is satisfied by which control, which collapses under a detailed inspector’s questioning.
How to adapt this checklist
- Set the site, trigger, and scope in the control block.
- Add subparts C and D items specific to your dosage form (for example sterile-specific facility items if you run aseptic processing).
- If the site is a laboratory, warehouse, or packaging-only operation, mark the non-applicable subparts N/A with a stated rationale rather than deleting them.
- Route every Fail into a tracked CAPA with an owner and a date, and set a re-assessment date for any subpart scoring below your internal threshold.
- Confirm every section number and reference against the current published regulation before issue. This checklist is educational guidance, not legal or regulatory advice, and completing it does not by itself demonstrate compliance.