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http://whqlibdoc.who.int/hq/1997/who_vsq_97.02.pdf

It presents a review of the types and extent of validations required by GMP, the preparation of a Master Validation Plan, formats for the equipment and systems qualifications and process and analytical assay validation protocols, and examples of the typical requirements for various validation studies. Document in pdf format; Acrobat Reader required.

Author(s): Chaloner - Larsson, Gillian, Anderson, Roger, Egan, Anik, Costa Filho, M.A.F. collab., Gomez Herrera, J.F. collab. Originator(s): World Health Organization - WHO

Resource added in: 17/05/2001

Available languages: English, Spanish

Objective: To aid vaccine manufacturers in the preparationand performance of the validation studies required by Good Manufacturing Practices (GMP) of the World Health Organization (WHO).

Vaccines, Quality Control, Chemistry, Pharmaceutical/methods, Reference Books, Guia [tipo de publicação], production of of substances, products and materials