Drug inspectors check your Batch Manufacturing Records for recent batches first. BMR completeness and calibration currency are the two most common GMP failures. Every Critical item must be in place.
23 items✎ Click to tick📷 Print / Save PDF
0 / 23 complete (0%)
Premises & Facility0/0
Facility layout meets Schedule M requirements for product categorySeparate areas for dispensing, manufacturing, packing.
CRITICAL
Air handling units in place with appropriate filtration for product category
CRITICAL
Water system validated / qualified for intended usePurified water for most pharma applications.
CRITICAL
Premises free from pest activity — pest control records current
MAJOR
Change rooms and gowning procedure documented and followed
MAJOR
Documentation0/0
SOPs written for every manufacturing and QC step — current and approvedVersion-controlled. Accessible at point of use.
CRITICAL
Batch Manufacturing Records (BMRs) completed for every batch — contemporaneousALCOA+ compliant. Filled during production, not after.
CRITICAL
BMRs retained for prescribed period beyond expiry date of batch
MAJOR
Deviation procedure — all deviations from SOP investigated and documented
MAJOR
Change control procedure — all changes to product, process, or facility managed formally
MAJOR
Raw Materials & QC0/0
All raw materials tested and released with AR numbers before use
CRITICAL
COAs on file from suppliers for all raw material batches
CRITICAL
In-process quality checks conducted per SOP with records
CRITICAL
Finished product testing before release — COA issued
CRITICAL
Out-of-specification (OOS) procedure — documented investigation for any OOS result
MAJOR
Equipment & Calibration0/0
Equipment qualification records (IQ/OQ/PQ) for critical equipment
MAJOR
All measuring and testing equipment calibrated with current certificatesExpired calibration = immediate critical finding.
CRITICAL
Equipment cleaning validation / SOP with records
MAJOR
Equipment maintenance schedule maintained
STANDARD
Personnel0/0
Qualified Person (QP) or responsible pharmacist identifiedDepends on product category and licence type.
CRITICAL
Health and hygiene records for all manufacturing staff
MAJOR
Gowning training records maintained
MAJOR
Training on SOPs and GMP principles for all staff with records
CRITICAL
How to use this checklist: Tick each item you currently have in place. Items marked CRITICAL are highest-priority audit findings. Items marked MAJOR will result in a major nonconformance if absent. Use the Print button to save a PDF for your records or to share with your quality team.
This checklist is a readiness guide — not a substitute for a formal gap assessment. Engage a NABCB-accredited CB for a pre-assessment before your formal certification audit. Read the full GMP guide ↗