GMP (Good Manufacturing Practice) audits

GMP (Good Manufacturing Practice) audits are among the most important quality-assurance processes across all manufacturing industries, including pharmaceuticals, food, cosmetics, medical devices, vaccines, and biological products.
Their primary objective is to ensure that manufacturing processes are safe, compliant, and aligned with international standards.

What makes GMP audits particularly challenging is the wide scope of inspection and the need for factories to continuously update their systems in line with the latest global requirements. GMP principles are regularly revised to keep pace with evolving technologies, production methods, and international safety regulations.


Types of GMP and Core Reference Standards
GMP audits cover a broad range of industries. Facilities must stay current with international standards in order to pass inspections by regulatory authorities.

1. Pharmaceuticals (Pharmaceutical GMP)
Key References: PIC/S Guide to GMP, WHO GMP Guidelines
Regulator: Thai FDA (Drug Division)

2. Food (Food GMP)
Key References: Codex Alimentarius, GMP Ministerial Regulations (Thai FDA)
Regulator: Thai FDA (Food Division)

3. Cosmetics (Cosmetic GMP)
Key References: ISO 22716, Thai FDA Cosmetic GMP Guidelines
Regulator: Thai FDA (Cosmetics & Hazardous Substances Division)

4. Medical Devices (Medical Device GMP)
Key References: ISO 13485, Thai FDA Medical Device GMP Guidelines
Regulator: Thai FDA (Medical Device Division)

5. Herbal Products (Herbal GMP)
Key References: WHO Guidelines on GMP for Herbal Medicines, Herbal GMP Regulations (Thailand)
Regulator: Thai FDA (Herbal Division)

6. Animal Feed (Feed GMP)
Key References: GMP+ International Feed Safety Assurance, National Bureau of Agricultural Commodity and Food Standards (ACFS)
Regulator: Department of Livestock Development

7. Biological Products / Vaccines (Biologicals & Vaccines GMP)
Key References: PIC/S Annex 2, WHO Technical Report Series (TRS)
Regulator: Thai FDA and Department of Livestock Development (for veterinary vaccines)


What Our Company Has Learned from Supporting GMP Audits
Over the years, our company has had the opportunity to serve as interpreters in various types of GMP audit assignments, including:

Medical devices
Pharmaceuticals and vaccines
Food manufacturing and quality-control laboratories
Biological and biotechnology products
We have worked alongside the Korean Ministry of Food and Drug Safety (MFDS) and Thai regulatory bodies. Throughout this experience, we learned that GMP audits go far beyond document review. They require aligning real-world manufacturing practices, quality-control processes, and international standards so that they support one another at every stage.


Key Considerations When Preparing for a GMP Audit
Study the latest standards Ensure the most recent versions of PIC/S, ISO, WHO, and other relevant guidelines are updated and available.
Prepare documentation precisely Be able to clearly explain how every production step aligns with GMP requirements.
Ensure staff readiness Personnel must understand their processes and be capable of answering auditors questions confidently.
Conduct internal mock audits Practice audits help identify gaps and allow issues to be corrected beforehand.
Use clear and accurate communication Especially for international audits, having interpreters with strong technical understanding is crucial.

Conclusion
GMP audits act as a mirror reflecting the true quality of a manufacturing facilityshowing whether it consistently meets legal and international production standards. At the same time, they represent an opportunity for organizations to elevate their operations and enhance their global competitiveness.