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).