GMP Audit Checklist For Packaging Manufacturers

No matter if you are preparing for an inspection or conducting regular self-audits, understanding and possessing all relevant documentation will facilitate an easier auditing process while simultaneously helping maintain GMP compliance proactively.

An effective GMP audit checklist can assist food manufacturers in assuring food safety, quality, traceability and accountability.

1. Documentation

Documentation is key in upholding GMP standards. When conducting a GMP inspection (‘GMP compliance audit’), an inspector will review documents related to facilities and equipment, manufacturing procedures from product development through manufacturing operations, supplier qualification procedures, batch tracing records, laboratory testing reports, deviation handling systems, complaints monitoring systems and employee training programs.

As soon as any noncompliance issues are identified in a GMP inspection, they must be promptly addressed by means of follow-up visits or communication between the inspector and manufacturer’s Quality Department to discuss investigation findings, CAPA system reviews or change control processes. Documenting of such issues is key so they can be addressed effectively to avoid future issues while keeping a facility GMP compliant; documentation can either be done through written reports or digital applications like 1st Reporting.

2. Work Areas

GMP audits provide regular checks that ensure your manufacturing facilities adhere to regulatory guidelines. They include annual evaluations and on-the-job inspections conducted by Quality teams embedded within production.

GMP food audits comprise of checks on cleanliness, pest activity, operational methods & practices, PPE use in buildings/ground areas/HACCP records as well as allergen controls (food allergies/foreign matter/HACCP records) as well as training procedures, employee responsibilities (both full-time and part-time employees), complaint handling procedures as well as training procedures and employee responsibilities (both full time/part time employees) for both full and part-time staff).

Your GMP audit checklist must include a section for work areas that meets these criteria: Ensure that your facility layout provides adequate separation between packing/labeling operations; keep rejected or on hold materials away from products in progress; ensure storage areas are free from debris;

3. Personnel

GMP audits provide valuable insight into your facility. Their purpose is to assess whether the food production processes adhere to FDA and USDA regulations and produce products which are safe for human consumption.

GMP audits often place emphasis on personnel requirements. An audit may look into your company’s procedures for reporting employee illnesses, worker dress codes, training methods or sanitation skills among other things. In addition, the audit could assess policies on lone worker safety and supervision policies as part of this evaluation.

Conducting audits can be time-consuming, particularly if there are multiple departments to inspect and monitor. Lumiform makes this task simpler by digitizing checklists and giving an instantaneous snapshot of progress.

4. Process Controls

Manufacturing areas must be equipped with appropriate facilities, equipment and a cleaning schedule that ensures sanitary conditions. Furthermore, procedures should be in place for controlling receipt, storage, handling, examination and reconciliation of packaging components as well as line clearance when different manufacturing operations are simultaneously taking place.

Last but not least, all production steps and equipment must be validated for optimal production, such as reports, protocols, and master formula.

An FDA GMP audit checklist helps food producers ensure safety standards remain high and maintain traceability across operations. With this digital inspection checklist, companies can assess compliance with GDP guidelines regarding buildings & facilities, equipment & personnel, raw materials production lab controls complaints & recalls complaints & recalls with ease – take notes upload photo evidence automatically calculate your score to easily create full reports without leaving your office!

5. Complaint Handling

Quality audit checklists provide manufacturers with a powerful way to conduct visual inspections. They cover every major aspect of manufacturing facilities and ensure all requirements are fulfilled.

Inspections conducted under GMP regulations often uncover noncompliance issues that must be promptly addressed – this includes conducting investigations, reviewing CAPA systems, and making changes to procedures as soon as possible.

As part of its oversight duties, the competent authority should have in place a process for notifying any regulated parties of any violations noted. This may include listing the site involved in a register or database as well as outlining how GMP certificates and manufacturing authorisations/establishment licenses will be suspended/withdrawn accordingly.