Quality Assurance Support in Pursual of WHO Prequalification for Bharat Biotech International Limited (BBIL), India

Bharat Biotech International Limited (BBIL) logo

Following a WHO prequalification audit of Bharat Biotech Limited it was decided that GMP QA support was required by PCS. In coordination with Bharat PCS executed the following activities after conducting a preliminary audit; the provision of a project director for the restructuring of the Quality Management System (QMS), liaison with the WHO on GMP matters, supporting the adherence and compliance to WHO-GMP, provide consultancy on changes to equipment and facilities and additional services on-site as required. Furthermore, PCS supported Bharat with mock-audits, new filling line project support, electronic QMS implementation and risk assessments on the polio process.

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