论药品生产验证总计划(英文版)(doc 32页)

论药品生产验证总计划(英文版)内容提要：
Aims of Qualification and Validation
Any significant changes to, premises, equipment or processes, which may affect the quality of the final product, directly or indirectly, should be qualified and validated.
The key elements of a qualification and validation program should be clearly defined and documented in a Validation Master Plan. The process should establish and provide documentary evidence that: premises, supporting utilities, equipment and processes have been designed in accordance with the requirements of GMP. This normally constitutes the Design Qualification or ‘DQ’ and includes confirmation that the premises, supporting utilities and equipment have been built and installed in compliance with their design specifications (this constitutes Installation Qualification or ‘IQ’) and that they operate in accordance with their design specifications (this constitutes Operational Qualification or OQ).
A specific process will consistently produce a product meeting its predetermined specifications and quality attributes (this constitutes Process Validation or PV. The term Performance Qualification or PQ may be used also).
Purpose
The VMP is intended to be a ‘live’ document that supports the design and construction of any production facility, its subsequent operation, maintenance and changes to the facility for its life span. The VMP should present an overview of the entire validation operation, its organisational structure, its content and planning. The core of the VMP is the list/inventory of items to be validated and the planning schedule.
The VMP should provide your organisation with the basis for validation and quality system activities required for cGMP compliance.  This will enable any sterile or non-sterile medicinal product that is produced, processed, stored or distributed, by the manufacturing unit, to be validated under the control of an appropriate quality system.
The VMP should provide a cross-reference to other documents, such as SOP’s, validation protocols, validation reports, and design plans. A rationale for the inclusion or exclusion of validations, from the approach adopted should be included.

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