Makmal & Kawalan Kualiti
Guidelines for Protocol Analysis
| Checklist | 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) | 5 July 2018 |
| Checklist for Sterility Test | 29 June 2018 |
| Checklist for Microbial Contamination Test (MCT) | 29 June 2018 |
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.
- Guideline for Sample Submission
Recent Updates
List of Private Laboratories Complying to NPRA Requirements for Traditional Products 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.