Prequalification program of Regulatory agency WHO

Posted by Kunal Sutar on March 27th, 2020

World Health Organization is a specialised agency of United Nations, working with 194 Member States with a commitment to achieve better health for everyone, everywhere.

The manufacturers of API, Formulation and quality control testing laboratories can participate in the program called Prequalification. Itdetermines capacity of manufacturer to produce product of consistent quality in accordance with international standards & WHO specifications.

WHO Prequalification program benefits populations requiring treatment for priority diseases like diarrhoeal disease, hepatitis B and C, HIV/AIDS, influenza, malaria, neglected tropical diseases, reproductive health, tuberculosis.

We will discuss API prequalification procedure in this article:

It is an independent procedure that identifies APIs that are of good quality & manufactured in compliance with WHO GMP. If prequalified API is used in manufacture of FPP- for which prequalification is sought, time is saved. Fees forNew application Full assessment: ,000

Components of API prequalification

a. Assessment of APIMF to verify compliance with WHO norms and standards

APIMF comprises of Open part (OP) & Restricted part (RP) of DMF. Additionally, applicants must submit Site Master File for each manufacturing site of each API and intermediate involved in preparation of API for which prequalification is sought.

API prequalification- Steps

  • Invitation to Manufacturers to submit Expression of Interest [EOI] for product evaluation
  • Application to WHO
  • Evaluation of information submitted using a screening checklist
  • Once all issues are resolved, the applicant will be asked to submit an updated APIMF that incorporates any changes made during assessment

b. Verification of GMP compliance

  • Manufacturers should request for inspection by WHO of relevant manufacturing sites, to assess WHO GMP compliance
  • Inspection can be waived off, if site is inspected by Pharmaceutical Inspection Co-operation Scheme (PICs) team member
  • If the site is found to be WHO GMP-compliant, the API will be recommended for pre-qualification.

Final step:

The prequalified API is listed on the WHO list of prequalified APIs with applicant’s name & API & manufacturing site details. Successful applicant will also be issued a certificate: WHO Confirmation of Active Pharmaceutical Ingredient Prequalification

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Kunal Sutar

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Kunal Sutar
Joined: August 17th, 2018
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