Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

Home DBER About Us Contents FAQs WHO LINKS

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.

2021 is 21st year of service of NCLB

Http://www.dra.gov.pk

inside nclb left wing nclb enterance inside nclb right wing

Home

WHO TRS: https://www.who.int/biologicals/technical_report_series/en/

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

 

 

List of Products presently under going Lot Release Performance of NCLB Lot Release system from 2007 onwards  
     
     

Home ]

Send mail to webmaster@nclbmoh.gov.pk with questions or comments about this web site.
Copyright © 2011 National Control Laboratory for Biologicals
Last modified: 13-Jul-2021