NEW ZEALAND HEALTHCARE PHARMACISTS' ASSOCIATION ...

1 NEW ZEALAND HEALTHCARE PHARMACISTS' ASSOCIATION Compounding Nutrition & Oncology SIG PHARMACY MANUFACTURING UNIT VALIDATION MASTER PLAN (VPM). Aims of Qualification and Validation General Notes 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.

2 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).

3 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.

4 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. VMP Document The VMP template is attached for completion as appropriate the document should be cross-referenced with design specifications, design plans and other relevant documentation. Appendices should contain all the relevant documentation referenced or stated in the VMP. NEW ZEALAND HEALTHCARE PHARMACISTS' ASSOCIATION Compounding Nutrition & Oncology SIG Hospital Logo Hospital Name VALIDATION MASTER PLAN Document Reference: Reference Number Revision: Draft Number or Revision Number Date of Issue: ____/____/____ Page: 2 of ___ Approved by: Name: Signature: Date: Production Team Leader Quality Control Officer Senior Engineer Compiled by Title: Name: Signature: Date: Validation Engineer Doc.

5 Ref.: NZHPA CNO-SIG Page: 3 of ____ Author: VALIDATION MASTER PLAN Date: Revision 01 CONTENTS LIST OF 5 DOCUMENT REVISION HISTORY .. 6 VALIDATION STEERING 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.

6 11 INTRODUCTION .. 11 PRODUCT GROUPS .. 11 PROCESSES .. 11 PRODUCT STORAGE AND DISTRIBUTION .. 11 PROJECT 12 SITE LOCATION .. 12 FACILITY DESIGN AND LAYOUT.. 12 PRODUCTION SUITES .. 12 Zone 1, Non-Sterile Manufacturing .. 12 Zone 2, Preparation of Cytotoxic Products and Parental Nutrition Products .. 12 EQUIPMENT AND SERVICES TO BE VALIDATED .. 14 IMPACT 14 RISK ASSESSMENT .. 14 VALIDATION MATRIX .. 14 VALIDATION ACTIVITIES .. 15 VALIDATION ACTIVITIES .. 15 User Requirement Specification (URS) .. 15 Technical Specification .. 15 Impact Assessment.

7 15 Design Review/Qualification .. 15 Factory Acceptance Tests .. 15 Commissioning .. 16 Installation Qualification .. 16 Calibration .. 16 Operational Qualification .. 17 Standard Operating Procedures .. 17 Performance Qualification .. 18 Combined Qualifications (I/OQ & O/PQ) .. 18 Process Validation (PV) .. 18 Cleaning Validation .. 18 Analytical Method and Laboratory Equipment 19 Doc. Ref.: NZHPA CNO-SIG Page: 4 of ____ Author: VALIDATION MASTER PLAN Date: Revision 01 Product Storage and Distribution Validation .. 19 Relocated Equipment .. 19 Computer Validation 20 Computer Operational Qualification.

8 Error! Bookmark not defined. VALIDATION REPORTS .. 20 VALIDATION HISTORY FILE .. 20 CHANGE 21 VMP REVISIONS .. 21 CHANGE CONTROL INITIATION .. 21 DEFINITION OF CHANGE .. 21 CHANGE CONTROL PROCEDURE .. 21 QUALITY MANAGEMENT .. 22 SCHEDULE OF STANDARD OPERATING PROCEDURES .. 23 PREVENTATIVE MAINTENANCE .. 24 SCHEDULE OF WORK PACKAGES .. 25 TRAINING .. 26 RESPONSIBILITIES AND APPROVAL OF PROTOCOLS AND DOCUMENTATION .. 27 PROTOCOL 27 APPROVAL OF PROTOCOLS AND REPORTS .. 27 APPROVAL OF VALIDATION 27 APPENDICES ANNEX 1 CLEANING VALIDATION MASTER PLAN ANNEX 2 ANALYTICAL METHOD VALIDATION MASTER PLAN Doc.

9 Ref.: NZHPA CNO-SIG Page: 5 of ____ Author: VALIDATION MASTER PLAN Date: Revision 01 LIST OF ABBREVIATIONS AHU Air Handling Unit NHS National Health Service BP British Pharmacopoeia O & M Operation and Maintenance BS British Standard OQ Operational Qualification CFR Code of Federal Regulations P&ID Piping and Instrumentation Diagram cGMP Current Good Manufacturing Practice PCA Patient Controlled Analgesia CIP Clean In Place PFD Process Flow Diagram CIVA Centralised Intravenous Additives PID Proportional Integral and Derivative Comm. Commissioning plc Programmable logic controller CPU Central Processing Unit PQ Performance Qualification DC Direct Current PV Process Validation DCC Design Change Control QA Quality Assurance DQ Design Qualification QC Quality Control DR Design Review QMS Quality Management System EDR Enhanced Design Review RA Risk Assessment EP European Pharmacopoeia Rev.

10 Revision EU European Union SAT Site Acceptance Test FAT Factory Acceptance Test SIP Sterilise/Sanitise In Place FDA Food and Drug Administration SOP Standard Operating Procedure FDS Functional; Design Statement SVA Small Volume Ampoules GA General Arrangement TPN Total Parenteral Nutrition GAMP Good Automated Manufacturing Practice URS User Requirement Statement GCP Good Cleaning Practice VCC Validation Change Control GEP Good Engineering Practice VMP Validation Master Plan GLP Good Laboratory Practice VSC Validation Steering Committee HACCP Hazard And Critical Control Point VTF Validation Technical File HS&E Health Safety And Environment WFI Water For Injection HTM Health Technical Memorandum HVAC Heating.