Current good manufacturing practices: what cGMP asks of a small manufacturer

Current good manufacturing practices are the rules governing how medicines, medical devices, food and similar regulated products are made, tested and documented. The word current is the part people miss: the standard is not a fixed checklist from the year the plant was built but what is accepted practice now, which means equipment, methods and records that were compliant a decade ago may not be today.

What current good manufacturing practices cover

• Premises and equipment suitable for the purpose, cleaned and maintained on a documented schedule.
• Qualification and validation: evidence that equipment and processes do what they are supposed to, repeatably.
• Written procedures for every operation, followed as written rather than as remembered.
• Trained personnel, with the training recorded and refreshed.
• Materials control — identity, supplier qualification, quarantine and release.
• Production records contemporaneous with the work, signed by whoever did it.
• Testing and release by a function independent of production.
• Deviation, investigation and change control, with corrective action tracked to closure.
• Traceability and recall capability, demonstrable in a drill rather than in theory.

Documentation is the deliverable

An inspector cannot watch you manufacture last month's batch, so the record is the product as far as they are concerned. Two failures dominate findings: records completed after the fact, which is visible in the handwriting and the timing, and procedures that describe something nobody does any more. Both come from the same root — documents treated as an obligation to satisfy rather than as the instructions people actually work from. Where the written procedure and the real practice differ, fix the one that is wrong, deliberately, rather than letting the gap persist.

Data integrity is now the most common area of serious findings. Shared logins, spreadsheets without audit trails and instrument data that can be overwritten are treated as seriously as a contamination problem, because they make every other record unverifiable.

Where a small manufacturer should start

1. Write the procedures for the operations you actually perform, in the words your operators use.
2. Put a numbered record against each procedure, completed at the time and signed.
3. Qualify suppliers of anything that touches the product, and keep the evidence with expiry dates.
4. Log every deviation, however minor, and investigate proportionately.
5. Control changes to process, equipment and suppliers through one route with an approval step.
6. Run a mock recall annually and record what it exposed.

Ettex Records holds the register side: procedures with versions and review dates, training records per person and operation, supplier qualification with expiry, and a deviation log with investigations and actions. It feeds the same discipline as a batch record without replacing validated production systems where a regulator requires them.