制药验证管理.ppt

* There are different types of documents related to validation: Master plans, protocols, reports and SOPs. Each manufacturer should have a validation master plan (VMP). It describes the overall philosophy, intention and approach to establishing performance adequacy (validation policy). It also identifies which items are subject to qualification and validation and the nature and extent of such validation. It defines the applicable validation and qualification protocols and procedures. During the inspection, you should evaluate the VMP to assess whether it covers the overall policy that defines validation and what should be subjected to validation. It should cover the responsible persons, what should be validated, where should the validation be done, when validation should be performed, why and how the validation should be performed. It should include a breakdown of the process, plant or equipment into separate parts. It should also determine which are critical to the quality of the product and therefore require validation, and at which stages. For example, in a project to commission a sterile manufacturing suite, the operation of the sterilizers is critical and will require IQ, OQ and PQ; and the operation of the ventilation system is critical and will require IQ, OQ and PQ. The VMP should be a concise and easy-to-read document which will serve as a guide to the validation committee and personnel who are responsible for performing validation. The VMP is also a source document for use by regulatory inspectors. * The VMP should typically include at least the following sections: Approval page and table of contents. Introduction and objectives. Facility and process description. Personnel, planning and scheduling. Responsibilities of committee members. Process control aspects. Equipment, apparatus, processes and systems to be validated. Acceptance criteria. Documentation e.g. validation protocols and reports. SOPs. Training requirements. * A validation p