GMP regulation of BCG vaccine

Mycobacterium bovis, Bacille Calmette-Guérin (BCG) represents the most widely used viable vaccine for tuberculosis, with over 3 billion doses administered. General agreement exists that BCG can protect against severe forms of systemic tuberculosis in children. GMP covers all aspects of the manufacturing process: defined manufacturing process, validated critical manufacturing steps, suitable premises, storage, transport; qualified and trained production and quality control personnel, adequate laboratory facilities, approved written procedures and instructions, records to show all steps of defined procedures have been taken. The guiding principle of GMP of BCG vaccine is that quality is built in to a product and not just tested in to a product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled – validation is that part of GMP that ensures that facility systems, equipment, processes and tests procedures are in control and therefore consistently produce quality product.

Author(s): Shushank Dixit, P. K. Sharma, Nitin Kumar, Rupesh Dudhe

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