【正文】 PHARMACY MANUFACTURING UNIT VALIDATION MASTER PLAN (VPM).General NotesAims of Qualification and ValidationAny 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 pliance 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).PurposeThe 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 anisational 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 anisation with the basis for validation and quality system activities required for cGMP pliance. This will enable any sterile or nonsterile 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 crossreference 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.VMP DocumentThe VMP template is attached for pletion as appropriate the document should be crossreferenced with design specifications, design plans and other relevant documentation. Appendices should contain all the relevant documentation referenced or stated in the VMP.3 / 32Company LogoCompany NameVALIDATION MASTER PLANDocument Reference: Reference NumberRevision: Draft Number or Revision NumberDate of Issue: ____/____/____Page: 3 of ___Approved by: Name: Signature: Date:Production Team LeaderQuality Control OfficerSenior EngineerCompiled byTitle: Name: Signature: Date:Validation Engineer4 / 32CONTENTS LIST OF ABBREVIATIONS....................................................................................................5 DOCUMENT REVISION HISTORY ........................................................................................6 VALIDATION STEERING COMMITTEE ................................................................................7 MEMBERSHIP OF VALIDATION STEERING COMMITTEE .................................................................................7 RESPONSIBILITIES ....................................................................................................................................8 Pharmacy Production Team Leader ..............................................................................................................8 Pharmacy Senior Production Technician ......................................................................................................8 Trust Senior Engineer.....................................................................................................................................8 Pharmacy Quality Control Officer.................................................................................................................8 Validation Engineer........................................................................................................................................8 INTRODUCTION.....................................................................................................................9 PURPOSES OF VMP .................................................................................................................................9 OVERVIEW OF PROJECT ...........................................................................................................................9 VALIDATION PHILOSOPHY .........................................................................................................................9 REGULATORY STANDARDS AND GUIDELINES..............................................................10 DESCRIPTION OF PRODUCTS AND PROCESSES ..........................................................11 INTRODUCTION.......................................................................................................................................11 PRODUCT GROUPS ................................................................................................................................11 PROCESSES...........................................................................................................................................11 PRODUCT STORAGE AND DISTRIBUTION ..................................................................................................11 PROJECT DESCRIPTION....................................................................................................12 SITE LOCATION ......................................................................................................................................12 FACILITY DESIGN AND LAYOUT.......................