This guide describes the requirements for carrying out validation of drug substance and drug product manufacture including packaging processes. Prospective, concurrent and retrospective validation are included together with sampling, testing, inspection, minimum batches, key intermediate / critical process step concept, yield changes and preparation of validation master plans, protocols and reports.

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	Process validation The Guide was build of following references FDA Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation FDA Guideline on Sterile Drug Products Produced by Aseptic Processing FDA Guide for Submitting Documentation for Sterilisation Process Validation in Applications for Human and Veterinary Drug Products FDA Guide to Inspection of Lyophilisation of Parenterals FDA Guide to Inspection of Bulk Pharmaceutical Chemicals FDA Guideline on General Principles of Process Validation FDA Biotechnology Inspection Guide, FDA PIC Document PH 1/96: Principles of Qualification and Validation in Pharmaceutical Manufacture Introduction of new processes into manufacturing or those intended to be changed must undergo prospective or concurrent validation whilst well established processes can be validated retrospectively through review of historic data and information. The Quality Assurance departments of the operational units are responsible as recipients for local implementation. Production or Development depending upon the area of operation are responsible for preparing the validation protocols / reports and for ensuring that manufacturing processes are validated, and maintained in a validated state, in accordance with this module. A Validation Master Plan must be prepared, and authorised, showing the elements and extent of the qualification and validation programme. Introduction of new processes into manufacturing or those intended to be changed must undergo prospective or concurrent validation whilst well established processes can be validated retrospectively through review of historic data and information. Premises, facilities and equipment used in the processes must be suitably qualified and instruments calibrated. Sampling plans must be based on sound scientific rationales. Testing and inspection methods used for assessing materials and products must be validated. An authorised validation protocol must be available prior to conducting the validation exercise and must include the criteria by which acceptance of the validation study will be measured. In the case of retrospective validation a validate protocol must be prepared which specifies the critical steps of the process. The validation report provides the rationale and justification, based upon historic data and information, as to why the process is considered to be validated. Manufacturing procedures used in the validation studies must be authorised and must be identical to those filed and intended to be used in the routine operations. For prospective or concurrent validation a minimum of three consecutive batches must be successfully manufactured in compliance with specifications and the requirements of the protocol in order to demonstrate that the process is valid. Critical processing parameters must be identified and the process validated within a specified range of operation. A validation report which includes a summary of the data, a reference to the raw data, a statement on the equivalency with the bio batches and the outcome of the validation study must be written, for review and approval by the validation team and by the QA department. Factors affecting processing such as changes in equipment, facilities, materials and procedures must be subjected to change control which may involve revalidation. A data review must be carried out at least annually to assess the need for revalidation.