Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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WHO LINKS

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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BIOLOGICALS : http://www.who.int/biologicals/en/

Vaccine Standardization: http://www.who.int/biologicals/vaccines/en/

Standardization of Biotherapeutic Products: http://www.who.int/biologicals/biotherapeutics/en/

List of Pre qualified vaccine:  http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/

Priority setting for WHO vaccine prequalification: http://www.who.int/immunization_standards/vaccine_quality/pq_priorities/en/

Vaccine regulation: http://www.who.int/immunization_standards/vaccine_regulation/en/

Medicines regulatory support: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/en/

Assessing national medicines regulatory systems: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/assesment/en/

Regulatory information and practical manuals: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/reginfo/en/

WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems: http://www.who.int/medicines/regulation/benchmarking_tool/en/

Vaccine PQ: http://www.who.int/immunization_standards/vaccine_quality/vq_index/en/

Vaccine manufacturers' corner: http://www.who.int/immunization_standards/vaccine_quality/vmc/en/

WHOPIRs for manufacturing sites inspected by WHO-PQT: http://www.who.int/immunization_standards/vaccine_quality/WHOPIRs_Listing/en/

WHO-National Control Laboratory Network for Biologicals (WHO-NNB): http://www.who.int/immunization_standards/vaccine_quality/who_nnb/en/

Vaccine Prequalification Dossier: http://www.who.int/immunization_standards/vaccine_quality/vaccine_PQ_dossier_122017/en/

WHO prequalification: information and guidance documents for vaccine manufacturers: http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_manufacturers_guidance/en/

Revised procedure for expedited review of imported prequalified vaccines for use in national immunization programmes: http://www.who.int/immunization_standards/vaccine_quality/expedited_review/en/

Environmental monitoring of clean rooms in vaccine manufacturing facilities: http://www.who.int/immunization_standards/vaccine_quality/env_monitoring/en/

Good Manufacturing Practices; TRS 999 Annex 2 Replacement of Annex 1 of WHO Technical Report Series, No. 822: http://www.who.int/biologicals/vaccines/good_manufacturing_practice/en/

Pharmaceutical Production main principles: http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/

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

WHO guideline for quality Risk Management: Annex 2, WHO Technical Report Series 981, 2013

 

 

 

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Last modified: 01-Sep-2018