The purpose of this Guide is to provide a detailed description of a science and risk-based approach for the Commissioning and Qualification of Facilities and Equipment, providing an update to the Baseline® Guide on C&Q that is adequate to allow the development and implementation of an efficient effective program.
The Guide will address a number of the areas that traditionally cause concern if engineering documents are to be used to support Qualification – e.g. Good Documentation Practice, Definition of test record document format and signature requirements, and effective use of vendor assessments.
The goal of the Team is to produce a document that describes a lean effective program that may be used to provide confirmation that facilities and equipment are fit for purpose.
This Good Practice Guide is intended to be a reference on the selection, specification, testing and operation of filters in pharmaceutical applications. It explains the principles and objectives of filter testing during manufacturing and on site.