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1、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 q
2、ualification 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 no
3、rmally constitutes the Design Qualification or DQ and in eludes con firmati on that the premises, support ing utilities and equipme nt have bee n built and installed in compliance with their design specifications (this constitutes Installation Qualification or IQ) and that they operate in accordance
4、 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
5、 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 organisational
6、 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-st
7、erile 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, suchas SOPs, validation protocols, validation reports, and design pla
8、ns. A rationale for the inclusion or exclusion of validations, from the approach adopted should be included.VMP DocumentThe VMP template is attached for completion as appropriate the document should be crossreferenced with design specifications, design plans and other relevant documentation. Appendi
9、ces should contain all the relevant documentation referenced or stated in the VMP.NEW ZEALAND HEALTHCARE PHARMACISTS ASSOCIATIONCompounding Nutrition & Oncology SIGCompany LogoCompany NameVALIDATION MASTER PLANDocument Reference:Reference NumberRevision:Draft Number or Revision NumberDate of Issue:/
10、 /Page:2 ofApproved by:Name:Signature:Date:Production Team LeaderQuality Control OfficerSenior EngineerCompiled byTitle:Name:Signature:Date:Validation EngineerNEW ZEALAND HEALTHCARE PHARMACISTS ASSOCIATIONCompounding Nutrition & Oncology SIGCONTENTS1.0 LIST OF ABBREVIATIONS2.0DOCUMENT REVISION HISTO
11、RY 63.0VALIDATION STEERING COMMITTEE 73.1 MEMBERSHIP OF VALIDATION STEERING COMMITTEE73.2 RESPONSIBILITIES83.2.1 Pharmacy Production Team Leader 83.2.2 Pharmacy Senior Production Technician 83.2.3 Trust Senior Engineer 83.2.4 Pharmacy Quality Control Officer 83.2.5 Validation Engineer 84.0 INTRODUCT
12、ION 94.1 PURPOSES OF VMP94.2 OVERVIEW OF PROJECT 94.3 VALIDATION PHILOSOPHY95.0 REGULATORY STANDARDS AND GUIDELINES 106.0 DESCRIPTION OF PRODUCTS AND PROCESSES 116.1 INTRODUCTION 116.2 PRODUCT GROUPS 116.3 PROCESSES 116.4 PRODUCT STORAGE AND DISTRIBUTION117.0 PROJECT DESCRIPTION 127.1 SITE LOCATION1
13、27.2 FACILITY DESIGN AND LAYOUT127.3 PRODUCTION SUITES 127.3.1 Zone 1, Non-Sterile Manufacturing 127.3.2 Zone 2, Preparation of Cytotoxic Products and Parental Nutrition Products 128.0 EQUIPMENT AND SERVICES TO BE VALIDATED 148.1 IMPACT ASSESSMENT148.2 RISK ASSESSMENT 148.3 VALIDATION MATRIX149.0 VA
14、LIDATION ACTIVITIES 159.1 VALIDATION ACTIVITIES 159.1.1 User Requirement Specification (URS) 159.1.2 Technical Specification 159.1.3 Impact Assessment 159.1.4 Design Review/Qualification 159.1.5 Factory Acceptance Tests 159.1.6 Commissioning 169.1.7 Installation Qualification 169.1.8 Calibration 169
15、.1.9 Operational Qualification 179.1.10 Standard Operating Procedures 179.1.11 Performance Qualification 189.1.12 Combined Qualifications (I/OQ & O/PQ) 189.1.13 Process Validation (PV) 189.1.14 Cleaning Validation 189.1.15 Analytical Method and Laboratory Equipment Validation 199.1.16 Product Storage and Distribution Validation 199.1.17 Relocated Equipment 199.1.18 Computer Validation Testing 209.1.19 Computer Operational Qualification 错误！未定义书签。9.2 VALIDATION REPORTS209.3
