Validation Master Plan

Transcription

1 Master Plan TITLE: SITE VALIDATION MASTER PLAN 2001 Quality Assurance Document No. XXXXX Rev.no. Page 1 of 15 Subject of Latest Revision: - CONTENTS 1. INTRODUCTION 2. OBJECTIVE 3. DEFINITIONS 4. SCOPE 5. SITE DESCRIPTION 5.1 Name of the Manufacturer and the Address 5.2 Brief Description of the Site 5.3 Company Site Plan 5.4 Operational Areas and Ownership 6. PROCEDURES 7. VALIDATION STATUS OF SITE SYSTEMS 7.1 Products Manufactured on Site 7.2 Material Management 7.3 Manufacturing Operations 7.4 Quality Operations 7.5 Site Services 7.6 Quality Control

2 Page 2 of INTRODUCTION This document defines the areas on site that require validation with identified responsibilities for these tasks. It describes the facilities, utilities, systems and manufacturing processes and documents the planned validation status of products, processes, equipment and utilities on the manufacturing site. 2. OBJECTIVE To prove that the site procedures, processes, equipment, materials, activities and systems deliver the expected results in terms of a quality product fit for its intended purpose. 3. DEFINITIONS There are several validation terms / abbreviations that are used generally within the pharmaceutical industry. The meaning of the terms as applied to validation are defined within this section CLEANING QUALIFICATION (CQ): Documented evidence that demonstrates that the cleaning procedures used for cleaning are consistently capable of achieving predetermined levels of cleanliness INSTALLATION QUALIFICATION (IQ): Documented evidence that facilities and equipment are installed as designed and specified for intended use. OPERATION QUALIFICATION (OQ): Documented evidence that utilities, equipment, instruments and systems operate as specified in accordance with design intent. PERFORMANCE QUALIFICATION (PQ): Documented evidence that when equipment and a process are operated within set parameters they consistently produce a product or desired output of the required quality. SITE VALIDATION MASTER PLAN (SVMP):A document that describes the facilities, utilities, equipment, automated and computer systems, and manufacturing processes at a site, as well as an assessment of the validation status of each element. VALIDATION (QUALIFICATION): Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. VALIDATION PLAN (VP): A written plan summarising in general terms the intended approach to validation, identifying protocols and associated documents which shall provide the necessary assurance that a specific process shall consistently produce material meeting predetermined specifications and quality attributes. VALIDATION PROTOCOL: A document which states how specific elements of validation / qualification will be conducted, including: tests to execute and test parameters, equipment, number of repetitions, and acceptance criteria. Protocols are reviewed and approved prior to the execution of the validation. VALIDATION REPORTS: A document relating the results of the validation activities and data with respect to protocol requirements and acceptance criteria, and the conclusions drawn.

3 Page 3 of 15 VALIDATION REVIEW: A periodic review of the validated facility or operation, to ensure continued compliance, which may result in the replication of the validation process or a specific portion of it. VALIDATION SUMMARY REPORTS: A written report, referencing a specific Plan, and summarising in general terms how the validation was conducted, the validation reports generated and the overall conclusions reached. 4. SCOPE All operations relating directly ( filling, packing etc.) or indirectly (services, etc.) to the production of Finished Pharmaceutical Products, that impact the quality, safety, purity or efficacy. 5. SITE DESCRIPTION 5.1 Name and Address of the Manufacturer Manufacturing site to which this Plan refers to 5.2 Brief Description of the Site Where is the company located? When did the construction of the facilities start? When did the business start? Describe the area, facility, building for manufacturing operation, QC, utility, incoming material and final product storge. Building surface areas are as follows :- Production Building : xxxx m² Storage : yyy m² Manufacturing : zzz m² Clean Rooms : ttt m² Basement : ooo m² Quality Control Laboratories : mmm m² Administration Building : nnn m² Utilities Building : ppp m² 5.3 Company Site Plan (plant lay out) 5.4 OPERATIONAL AREAS AND OWNERSHIP SITE - Managing Director MATERIALS MANAGEMENT Logistic Manager WAREHOUSE DISTRIBUTION STOCK CONTROL MANUFACTURING OPERATIONS / Planning - Production Manager STERILE INJECTABLE SOLUTIONS FREEZE-DRIED PRODUCTS QUALITY OPERATIONS / Information Systems Quality Assurance Manager DOCUMENTATION QUALITY SYSTEM VALIDATION

4 Page 4 of 15 SITE SERVICES Engineering Maintenance Manager UTILITIES GROUNDS QUALITY CONTROL Quality Control Manager CHEMISTRY MICROBIOLOGY WAREHOUSE LABORATORY 6. PROCEDURES The validation system is supported by a number of Standard Operating Procedures. This section lists the relevant procedures, which will be used for validation purposes. Title System Practices Document Content Document Management of Automated Systems Cleaning of Analytical Methods Equipment Qualification 7. VALIDATION OF SITE SYSTEMS 7.1 Products to be manufactured on Site It is anticipated that the following products will be manufacturing, inspected, packed, tested and released on site :- 7.2 MATERIALS MANAGEMENT Area Owner : Materials Manager Areas: Warehouse In-Process and Finished Product Cold Storage Elements to be Validated :- Cold Room located in the Warehouse Cold Rooms for : - Finished Product Storage - Quarantine Storage - Work in Progress Packaging for Dispatch s in Progress Area Responsibility Start Completion

5 Page 5 of 15 Planned Area Production Freezers 016 Warehouse Cold Room 022 Pallet changing room 09B Start Completion Responsibility IQ/OQ QA Q1 / 02 Q1 / 02 IQ/OQ QA Q3 / 01 Q3 / 01 IQ/OQ Material Management Q3 / 01 Q3 / MANUFACTURING OPERATIONS Area Owner : Production Manager Areas with a Requirement :- Area Description 019B Solvent Storage 020B Pharmaceutical Corridor 025 Washing Area 025A Washing Cabinet 026 Material Airlock 030 Aseptic Room 032 Preparation Room 036 Vial Washing & Sterilising + Autoclave Room 037 Cold Room 038 Filling Room 057 Visual Inspection Room 062 Capping Room 015A Inspection, labeling, packaging Elements to be Validated :- Room Specification Equipment Utilities Process s in Progress Area Responsibility Start Completion

6 Page 6 of 15 Planned Description Material Airlocks 023 Personnel Airlocks 024A Washing Area 025 Aseptic Room 030 Filling Line 038 Capping machine 062 Fedegari Autoclave Room Specification EMS Room Specification EMS Room Specification EMS Room Specification EMS Start Completion Responsibility IQ/OQ Production / IQ/OQ Production / IQ/OQ 45 Litre Vessels x 6 IQ/OQ Production / QA Q4 / 01 Q4 / 01 Autoclave Autoclave Cleaning of Filling Equipment PQ Solvent Sterilisation cycle PQ Stoppers & Filling Equipment Process Qualification Production Q3 / 01 Q4 / 01 Media Fills x 3 Process Qualification Production / Balance x 2 IQ/OQ Production Q3 / 01 Q4 / QUALITY OPERATIONS Area Owner : Quality Assurance Manager Areas: Offices Elements to be Validated :- DOP Generator DOP Detector Particle Counter Temperature Data-logger Temperature Calibrator Pressure Differential Gauge

7 Page 7 of 15 Relative Humidity Meter Vane Anemometer s in Progress Area Responsibility Start Completion Planned Description Responsibility Start Completion DOP Generator IQ/OQ QA Q4 / 01 Q4 / 01 DOP Detector IQ/OQ QA Q4 / 01 Q4 / 01 Particle Counter IQ/OQ QA Q4 / 01 Q4 / 01 Temperature Datalogger IQ/OQ QA Q4 / 01 Q4 / 01 Temperature Calibrator IQ/OQ QA Q4 / 01 Q4 / 01 Vane Anemometer IQ/OQ QA Q4 / 01 Q4 / SITE SERVICES Area Owner : Engineering Maintenance Manager Areas: Utilities Building Offices Production Basement Elements to be Validated :- Water Purification System Clean steam Compressed Air Nitrogen Supply Air handling unit s in Progress

8 Page 8 of 15 Area Responsibility Start Completion Planned Description Responsibility Start Completion Water Purification IQ/OQ QC Q3 / 01 Q4 / 01 System Water Purification PQ QC Q4 / 01 Q4 / 02 System Clean Steam IQ/OQ QA Q4 / 01 Q4 / 01 Compressed Air IQ/OQ QA Q4 / 01 Q4 / 01 Nitrogen IQ/OQ QA Q4 / 01 Q4 / 01 Air Handling Units QC Production IQ/OQ QA Q4 / 01 Q4 / QUALITY CONTROL Area Owner : Quality Control Manager Areas: QC Laboratories Offices Animal House Elements to be Validated :- Equipment Utility Room specification Analytical Methods (Chemical and Microbiological) s in Progress Area Responsibility Start Completion Planned Description Responsibility Start Completion

9 Page 9 of 15 Description Responsibility Start Completion Virology 1 Room L015 Specification Materials Airlock Room L017 : L021 Specification Personnel Airlock Room L018 L019 L020 Specification Balances IQ/OQ QC Q3 / 01 Q4 / 01 Sensitivity 10mg, 100mg,0.1 mg Autoclave IQ/OQ/PQ L011 L015 ph Meter IQ/OQ QC Q3 / 01 Q4 / 01 Analytical Test Methods Qualification QC Q3 / 01 Q4 / 01 Refrigerator 2-8 C IQ/OQ/PQ Oven 105 C IQ/OQ/PQ Conductivity Meter IQ/OQ QC Q3 / 01 Q4 / 01 Microfil Filtration IQ/OQ QC Q3 / 01 Q4 / 01 System Glassware Washer IQ/OQ QC Q3 / 01 Q4 / 01 Waterbath IQ/OQ QC Q3 / 01 Q4 / 01 LAF Cabinet IQ/OQ QC Q3 / 01 Q4 / 01 Thermometers Calibration QC Q3 / 01 Q4 / 01 Spectrophotometer IQ/OQ QC Q3 / 01 Q4 / 01 Pyrogen test equipment IQ/OQ QC Q3 / 01 Q4 / 01 Inverted microscope IQ/OQ QC Q3 / 01 Q4 / 01 Pipettes Calibration QC Q3 / 01 Q4 / 01 Qualification Sterility Test System Qualification QC Q3 / 01 Q4 / 01