Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2034495 | Biologicals | 2009 | 4 Pages |
Abstract
Stability testing is an integral part of the vaccine manufacturing process and is crucial for the success of immunization programs. WHO (World Health Organization) has recently published guidelines on the stability testing of vaccines. These guidelines enlist scientific basis and principles for stability testing at various stages like development, pre-clinical, clinical, licensing, lot release and post-licensure monitoring. DCVMN (Developing Countries Vaccine Manufacturers' Network) is an international body of developing countries vaccine manufacturers and has viewpoints on technical and administrative issues in stability testing of vaccines. We here highlight viewpoints, possible roles and global expectations of DCVMN in the area of stability testing of vaccines.
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Authors
Suresh S. Jadhav, Vikas Dogar, Manish Gautam, Sunil Gairola,