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Drug Regulatory Authority of Pakistan

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Tetanus Toxoid

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

inside nclb left wing nclb enterance inside nclb right wing

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Manufactured by NIH Islamabad, and AVP Islamabad WHO TRS
Both manufacturers use concentrate from same manufacturer; the imported concentrate is diluted adsorbed on aluminium base adjuvant and filled in either multidose vials or single dose ampoules. Recommendations for Diphtheria, Tetanus, Pertussis and Combined Vaccines, Amendments 2003
WHO Technical Report Series, No. 927, Annex 5
Both manufacturers work in GMP compliant facilities and test the vaccine according to WHO recommendations. Requirements for Diphtheria, Tetanus, Pertussis and Combined Vaccines
WHO Technical Report Series 800, 1990

 

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