Auditor's checklist
What a real auditor actually checks, sourced from public, current regulatory/standards documents — not a generic best-practice list. Useful as a reference before uploading a document, or on its own.
Source
FDA Compliance Program Guidance Manual 7356.002, "Drug Manufacturing Inspections"
Chapter 56 "Drug Quality Assurance," Date of Issuance 09/16/2022, Implementation Date 10/17/2022
https://www.fda.gov/media/75167/download⌕
1. Quality System (overarching — mandatory in every inspection)2. Facilities and Equipment System3. Materials System4. Production System5. Packaging and Labeling System6. Laboratory Control System
1. Quality System (overarching — mandatory in every inspection)16
- ☐Quality oversight of contracted operations and material suppliers
- ☐Management oversight of the quality system's development, implementation, monitoring, and continual improvement
- ☐Documented quality risk management program (cross-contamination, adulteration, hazardous impurities)
- ☐Product reviews conducted at least annually with statistical trend analysis (21 CFR 211.180(e))
- ☐Complaint reviews (quality and medical) — documented, evaluated, investigated timely
- ☐Discrepancy/failure investigations — documented, timely, scientific root-cause identification; CAPA effectiveness evaluated
- ☐Change management — documented justification, risk evaluation, SME review, pre-implementation approval, effectiveness evaluated
- ☐Reporting of changes for approved application products
- ☐Rejects — investigation expanded where warranted, CAPAs implemented
- ☐Stability failures — investigation expanded, need for FARs/BPDRs/recalls evaluated
- ☐Quarantine products
- ☐Validation approval documented (computer, manufacturing process, laboratory methods)
- ☐Training/qualification of employees in CGMP, including quality functions and risk management
- ☐Ongoing monitoring of process performance and product quality; significant issues escalated to senior management
- ☐Reprocess/rework — evaluation and approval documented; impact on validation/stability assessed
- ☐Returns/salvages — assessment, investigation, disposition
2. Facilities and Equipment System11
- ☐Facility cleaning and maintenance
- ☐Layout and air handling to prevent cross-contamination (e.g. penicillin, beta-lactams, steroids, hormones, cytotoxics)
- ☐Dedicated areas to prevent mix-ups; general air handling systems
- ☐Change control for the building; lighting/water/sanitation/waste disposal; pest control and cleaning agents
- ☐Equipment installation/operational qualification
- ☐Equipment design/size/location adequacy; non-reactive surfaces
- ☐Cleaning validation for reusable/multiproduct equipment
- ☐Qualification/calibration/maintenance of storage equipment
- ☐Computer qualification, validation, and security for equipment
- ☐Change control for equipment; equipment identification practices
- ☐Documented investigation of unexpected discrepancies
3. Materials System13
- ☐Training/qualification of personnel
- ☐Identification and inventory of components, containers, closures
- ☐Storage under quarantine until tested/examined and released
- ☐Representative sampling; identity testing on each lot
- ☐Testing or validation of supplier's test results
- ☐Rejection of non-conforming materials; investigation of component source
- ☐First-in-first-out use of components/containers/closures
- ☐Water and process gas supply — design, maintenance, validation, operation
- ☐Container/closure inertness (not additive, reactive, or absorptive)
- ☐Change control for materials handling; computerized-process validation and security
- ☐Finished product distribution records by lot
- ☐Documented investigation of unexpected discrepancies
- ☐Risk management program for hazardous impurities in components
4. Production System17
- ☐Training/qualification of personnel; change control for processes
- ☐Charge-in procedures; formulation at not less than 100 percent
- ☐Equipment identification with contents and manufacturing phase/status
- ☐Cleaning/sterilization/depyrogenation validation for containers and closures
- ☐Yield calculation and documentation (actual vs. theoretical)
- ☐Contemporaneous and complete batch production documentation
- ☐Established time limits for production phases
- ☐In-process controls, tests, examinations (pH, mix adequacy, weight variation, clarity)
- ☐Consistency between in-process specs and final drug product specs
- ☐Prevention of objectionable microorganisms in non-sterile products
- ☐Line clearance and preprocessing procedures
- ☐Master production and control records; batch production and control records
- ☐Process validation including computerized/automated processes
- ☐Ongoing statistical evaluation of process variability
- ☐Change control; revalidation need evaluated
- ☐Documented investigation of unexpected discrepancies
- ☐Control strategy for operations at risk of forming hazardous impurities
5. Packaging and Labeling System17
- ☐Training/qualification of personnel
- ☐Acceptance operations for packaging and labeling materials
- ☐Change control for packaging/labeling operations
- ☐Label storage, issuance, examination, and reconciliation
- ☐Control of labels similar in size, shape, or color for different products
- ☐100% verification (electronic/visual) or dedicated lines for similar-looking finished-product labels
- ☐Gang-printing controls; control of filled-unlabeled containers under multiple private labels
- ☐Packaging records including specimens of all labels used
- ☐Examination of the labeled finished product; inspection (proofing) of incoming labeling
- ☐Lot-number control and destruction of excess labeling
- ☐Physical separation between different labeling and packaging lines
- ☐Monitoring of printing devices on manufacturing lines
- ☐Line clearance, inspection, documentation
- ☐Expiration-date accuracy on the label
- ☐Tamper-resistant packaging compliance (21 CFR 211.132)
- ☐Validation of packaging/labeling operations, including computerized processes
- ☐Documented investigation of unexpected discrepancies
6. Laboratory Control System17
- ☐Training/qualification of personnel; staffing adequacy
- ☐Equipment and facility adequacy for intended use
- ☐Calibration and maintenance programs for analytical instruments
- ☐Validation and security of computerized/automated processes
- ☐Reference standards — source, purity, assay, equivalency testing
- ☐System suitability checks on chromatographic systems (GC, HPLC)
- ☐Specifications, standards, and representative sampling plans
- ☐Control strategy for hazardous impurities in components/finished product/degradants
- ☐Adherence to written methods of analysis; method validation/verification
- ☐Change control for laboratory operations
- ☐Required testing performed on the correct samples
- ☐Documented investigation of unexpected discrepancies
- ☐Complete analytical records; quality and retention of raw data (chromatograms, spectra)
- ☐Correlation of result summaries to raw data; no unused/unexplained data
- ☐Adequate out-of-specification (OOS) procedure with timely investigation
- ☐Adequate reserve samples with documented examination
- ☐Stability testing program with stability-indicating method validation
PIC/S also publishes an "Audit Checklist" (PS/W 1/2005 Rev.3) — but it audits a national regulatory authority's own inspection programme, not a manufacturer directly, so it's not included here to avoid implying it applies to your site.