药品生产验证总计划

宝岛优品—倾心为你打造精品文档宝岛优品—倾心为你打造精品文档 论药品生产验证总计划论药品生产验证总计划 宝岛优品—倾心为你打造精品文档 宝岛优品—倾心为你打造精品文档宝岛优品—倾心为你打造精品文档 Pharmacy Manufacturing Unit Validation Master Plan (VPM). General Notes Aims of Qualification and Validation Any significant changes to, premises, equipment or processes, which m ay affect the quality of the final product, directly or indirectly, should be qu alified and validated. The key elements of a qualification and validation program should be clearly defined and documented in a Validation Master Plan. The process s hould establish and provide documentary evidence that: premises, supporti ng utilities, equipment and processes have been designed in accordance wit h the requirements of GMP. This normally constitutes the Design Qualificati on or ‘DQ’ and includes confirmation that the premises, supporting utili ties and equipment have been built and installed in compliance with their d esign specifications (this constitutes Installation Qualification or‘IQ’) an d that they operate in accordance with their design specifications (this const itutes Operational Qualification or OQ). A specific process will consistently produce a product meeting its prede termined specifications and quality attributes (this constitutes Process Valid ation or PV. The term Perance Qualification or PQ may be used also). Purpose The VMP is intended to be a ‘live’ document that supports the desi gn and construction of any production facility, its subsequent operation, m aintenance and changes to the facility for its life span. The VMP should pres ent an overview of the entire validation operation, its organisational struct ure, its content and planning. The core of the VMP is the list/inventory of it ems to be validated and the planning schedule. The VMP should provide your organisation with the basis for validatio n and quality system activities required for cGMP compliance. This will ena 宝岛优品—倾心为你打造精品文档 宝岛优品—倾心为你打造精品文档宝岛优品—倾心为你打造精品文档 ble 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 ratio nale for the inclusion or exclusion of validations, from the approach adopt ed should be included. VMP Document The VMP template is attached for completion as appropriate the docu ment should be cross-referenced with design specifications, design plans an d other relevant documentation. Appendices should contain all the relevan t documentation referenced or stated in the VMP. 宝岛优品—倾心为你打造精品文档 宝岛优品—倾心为你打造精品文档宝岛优品—倾心为你打造精品文档 Company LogoCompany Logo Company NameCompany Name VALIDATION MASTER PLANVALIDATION MASTER PLAN Document Reference:Document Reference: Revision:Revision: Date of Issue:Date of Issue: Page:Page: Approved by:Approved by: Production Team Leader Quality Control Officer Senior Engineer Compi