Regulatory Information

Laboratory & Quality Control

Guideline for the Submission of Analytical Procedure and Analytical Method Validation for Pharmaceutical Products

 

Document Updated

Checklist for Analytical Method Validation (Identification, Assay, Dissolution & Related Substances)

1 July 2018
Checklist for Analytical Procedure 1 July 2018
Checklist for Bacteria Endotoxin Test (BET) 4 November 2022
Checklist for Sterility Test 29 June 2018
Checklist for Microbial Contamination Test (MCT) 29 June 2018

Guideline for Application as NPRA Recognized Laboratories for Quality Control Testing in Natural Products

 

Document Updated

Checklist for Adulteration Screening Test in Natural Products

1 February 2022
Checklist for Determination of Lovastatin in Natural Products 1 February 2022
Checklist for Disintegration Test in Natural Products 1 February 2022
Checklist for Uniformity of Weight in Natural Products 1 February 2022
Checklist for Heavy Metal Testing (As,Cd,Hg,Pb) In Natural Products 1 February 2022
Checklist for Microbial Contamination Test In Natural Products 11 May 2022
Guideline for the Recognition of Laboratories by NPRA for Natural Products Analysis Services 10 May 2023
Application form for Private Laboratory Recognition by NPRA for Natural Products Testing 14 October 2022

Guideline for Application as NPRA Recognized Laboratories for Quality Control Testing on Raw Materials Used in Natural Products

 

Document Updated

Garis Panduan Pengiktirafan Makmal Tempatan Analisis Bahan Mentah dalam Produk Semula Jadi

15 September 2023
Checklist for Quality Control Testing on Raw Materials Used in Natural Products 15 September 2023
Borang Permohonan Pengiktirafan Makmal Tempatan Analisis Bahan Mentah dalam Produk Semula Jadi 15 September 2023

List of Private Laboratories Complying to NPRA Requirement for Natural Product Testing

 

List of private laboratories that complied to NPCB’s requirement for Traditional Product Testing - a guide to traditional product manufacturers.

Please refer to FAQ for List of Private Laboratories Complying to NPCB’s Requirements for Traditional Products Testing

 

Note: The implementation date on sample testing by listed laboratories for the purpose of registration will be announced in advanced.

Recent Updates

  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Laboratory & Quality Control
All publications