Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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4.Licensing

NCLB implements Lot release and Lab testing of Biological Drugs as per Schedule I of DRAP Act, 2012 (Act No. XXI of 2012)

and is part of DRAP Authority under Section 3 of this Act.

DRAP Act, 2012 scanned pdf file. 

Http://www.dra.gov.pk

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Licensing and GMP Inspection of Manufacturing Units (LIMU)

Development History of WHO GMP Guidlelines

Pharmaceutical

The first WHO draft on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently submitted to to the Twenty-first World Health Assembly under the title Draft requirements for good manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialities and was accepted. Subsequently these recommendations have been updated

WHO Good manufacturing practices list (GMP): http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/

Biological

Good Manufacturing practices (GMP) for biological products were first published by WHO in 1992. The current version WHO TRS No. 999 Annex 2 reflects subsequent developments that have taken place in science and technology, and in the application of risk-based approach to GMP.

The contents of this document should be considered complementary to the general recommendations set out in the current WHO good manufacturing practices products main principles and in other WHO documents related specifically to the production and control of biological products.

Good Manufacturing Practices TRS 999 Annex 2 has now Replaced of Annex 1 of WHO Technical Report Series, No. 822.

Pakistan

All local vaccine manufacturers need to have a valid drug manufacturing license and dedicated biotech or vaccine sections along with animal house test facility before being approved.

For cGMP inspection the guiding document is available. This document was developed with the assistance of W.H.O.

 

Right Click on the image and download.

 

 

This guideline inspection tool is to be used in addition to the basic pharmaceutical level DRAP Inspection Check List as per Schedule-BII designed as per Drugs Act, 1976.

Environment monitoring of clean room in vaccine manufacturing facilities is a critical requirement to be considered by the manufacturers of vaccines, for this purpose a guiding document by WHO for environment monitoring may be considered

 

 

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