Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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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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National Control Laboratory for Biologicals (NCLB), Islamabad

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Mandate of National Control Laboratory for Biologicals

No human biological drug is allowed sale and use until a Lot Release Certificate from the Federal Government Analyst of the National Control Laboratory for Biologicals, Islamabad has been obtained.

NCLB initiated WHO recommendations for Lot Release from year 2000 onwards

Lot release of vaccines by, as a minimum, review of a summary protocol and access to a laboratory are two of the essential functions of a national regulatory authority for assuring the quality of vaccines used in the immunization program as defined by WHO.

Lot release is the process of evaluating each individual lot of a licensed product before giving approval for its release onto the market. This process is carried out for vaccines and other biologicals in most countries.

General practices of release involves the review of manufacturer's production data and quality control test results (product summary protocol) by the national control laboratory (NCL)s. This may or may not be supplemented by laboratory testing by the national control laboratory.

 

Important Information for Public (FAQs)

Vaccines, Sera and other Biological Drugs release data is placed year wise for confirmation by the users. Please ask from the Medical Store copy of Lot Release Certificate issued by NCLB and check lot or batch number of the Biological Drug from the list: Check Lot/Batch number here. If a lot or batch number is not in this list then it was not released by NCLB.

Please either email (dir@nclbmoh.gov.pk) or call by phone during office hours 9am to 5pm (051 9255838)  or send Whatsup or sms on 0300 5192196  for further confirmation or any complaint or query.

*IMPORTANT CLARIFICATIONS:

1.      What are "Biological Drugs"?

Biological drugs are produced by biological systems and require standardization by biological assays according to the relevant and updated recommendations of the World Health Organization published in Technical Report Series and Biological Standardization Report

2.      How is Lot Release applicable to imported batches?

This is clarified that Lot Release is applicable to each lot in every shipment. If the same lot is imported once gain but at a different time and shipment the Lot Release shall still apply. 

3.      A question has arises whether field samples of a lot released by NCLB may be retested by NCLB?

This is clarified that Lot Release and testing of field samples are two different procedures and both are the responsibility of the NCLB. Field samples collected from one city may have different results from samples of the same lot collected from another city. Therefore, they are to be tested by the NCLB separately without any doubt and confusion even if they were passed earlier by NCLB.

 

Lot release certificate guarantees the required potency of the vaccines or other temperature sensitive biologicals only when they are stored at proper temperature, otherwise test reports of samples of the same lot stored under two different storage conditions could not be the same. 

 

4.     A question has earlier arisen whether veterinary vaccines are to be included in the definition of "Biological Drugs" or not for the purpose of "Lot release"?

Academically and scientifically veterinary vaccines are "Biological drugs" but for the purpose of "Lot Release" W.H.O. Guidelines are followed that relate to human biological drugs only; veterinary vaccines are covered by World Organization for Animal Health (OIE), these vaccines presently do not require "Lot Release", a few brands of avian influenza vaccines may required quality control by the National Veterinary Laboratory and this is mentioned on the Registration Letter issued by the GOP.

Information for the Importers, and Manufacturers

NCLB Pakistan Guidelines

A quick guide for Lot release
(download in pdf format)  

The Lot Release System is based on:- Summary Protocol Review.

According to Word Health Organization (WHO) the primary responsibility of the quality of a Biological Drug rests with the manufacturer. The national regulatory authorities of each country assures that the manufacturers are performing necessary control measures at each level of production through regular inspection, testing and  batch production record review process that is applied on each lot manufactured in the country...

Guidelines for Licensing / Registration of Biological Drugs

(download new pdf format)

 

Registration and licensing of biological products.

TRS 858, Annex I.

Guidelines for cGMP Inspections of Biological drugs Manufacturers

download new pdf format) 

Licensing and GMP Inspection of Manufacturing Units (LIMU) in Pakistan

 

Biological products, GMP

Title: Good Manufacturing Practices for biological products; Adopted 1991,

WHO TRS 999, Annex 2 Replacement of Annex 1 of WHO TRS No, 822

WHO TRS No 822, Annex 1

 

Federal Government Analyst for Biological Drugs

Contact Information

Telephone
+92 51 9255263
Fax
+92 51 9255732
Postal address
NCLB at NIH premises, NIH Chak Shazad, Islamabad. Pakistan.
Electronic mail
General Information: dir@nclbmoh.gov.pk;
Webmaster:
        webmaster@nclbmoh.gov.pk

 

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Last modified: 02-Sep-2018