Guidance Document For Preparation of Good Manufacturing Practice (GMP) Inspections On Traditional Medicines, Health Supplements and Cosmetics Manufacturers, Fourth Edition, June 2024

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Effective 1st June 2024, the following documents need to be uploaded into the QUEST system during the application of initial / pre-licensing/ pre-approval GMP inspection:

1. Latest Site Master File

2. Layout Approval Letter

3. Pre-inspection Checklist (NPRA/431/16)*

*must be completed and uploaded together with the Layout Approval Letter for traditional medicines, health supplements and cosmetics manufacturers. 

 

Objectives:

1. To facilitate the process of initial/ pre-licensing/ pre-approval application through the QUEST system.

2. To update Guidance Document For Preparation Of Good Manufacturing Practice (GMP) Inspections On Traditional Medicines, Health Supplements And Cosmetics Manufacturers.

Click below to download the Guidance Document and Pre-inspection Checklist (NPRA/431/16). 

 

Document Name Updated
Guidance Document For Preparation of Good Manufacturing Practice (GMP) Inspections On Traditional Medicines, Health Supplements and Cosmetics Manufacturers, Fourth Edition, June 2024 31/5/2024
NPRA.431.16.3 Pre-inspection Checklist 31/5/2024
Garis Panduan Persediaan Pemeriksaan Amalan Perkilangan Baik (APB) Bagi Pengilang Tradisional, Suplemen Kesihatan dan Kosmetik, Edisi Keempat, Jun 2024 31/5/2024
NPRA.431.16.3 Senarai Semak Pra-pemeriksaan 31/5/2024

 

 

 

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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