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 Application of Private Laboratories Complying to NPRA Requirements for Natural Products Testing | 14 October 2022 |
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 |
15 October 2022 | |
Checklist for Quality Control Testing on Raw Materials used in Natural Products | 15 October 2022 |
Application Form for NPRA Recognized Laboratories for Quality Control Testing on Raw Materials Used in Natural Products | 15 October 2022 |
Guideline for the Submission of Product Samples for Laboratory Testing
- The submission of sample for laboratory testing is as part of the registration process.This guideline consists of the general and specific requirements for the submission of samples to the Centre for Quality Control for laboratory testing. The general requirements define the condition of the samples to be submitted whereas the specific requirements illustrate the additional details needed according to the category of product.
- The applicant is given a period of 14 working days from the date of confirmed payment to send samples for laboratory testing. If the samples are not submitted within the specified time frame, the product registration application shall be tabled to the Authority for rejection.
- The applicants shall comply with these requirements and failure to meet any of these requirements may cause rejection of the samples.
Recent Updates
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.