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Available Guidelines
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This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: the Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation by PIC/S.
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This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II.
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