This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by Good Manufacturing Practices (GMP) of the World Health Organization (WHO). The WHO GMP publications, other GMP Regulations/Guidelines and many publications on the concept and process of validation for pharmaceutical manufacture were consulted
during preparation of the Guide. These references are listed in Appendix 3. The emphasis in this guide is on WHO requirements for validation.

The whole 99 pages article is available for download at Downloads section of FarmavitaR+.

The Guide 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. Validation of computerized systems is not covered in this Validation Guide. In addition to these examples, the manufacturers who have collaborated on this Guide have contributed a list of titles of their validation documents and one has provided several actual documents as examples. These lists and examples are presented to aid manufacturers in developing the full range of validation documents and information for performance and recording data. These can be used by manufacturers as reference for preparing or revising their own validation protocols. They may also be used to assess IQ and OQ services offerred by suppliers of new equipment..

This guide for Validation is Part 2 of 2: Part 1 is a guide to Standard Operating
Procedures and Master Formulae.

The whole 99 pages article is available for download at Downloads section of FarmavitaR+.