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Ministry of National Health Services, Regulations and Coordination Drug Regulatory Authority of Pakistan National Control Laboratory for Biologicals
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. 2021 is 21st year of service of NCLB
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National Control Laboratory for Biologicals (NCLB), Islamabad
New: Lot Release Request Form in MS Word Format 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,
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 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.
Federal Government Analyst for Biological Drugs Contact Information
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