【正文】 provide aseptically dispensed intravenous products and manufactured sterile and nonsterile products to ______________ Hospital patients. Validation Philosophy The VMP is intended to be a ‘live’ document that initially supports the design and construction of the facility and subsequently the operation, maintenance and change of the facility for its entire life. It will provide the basis for validation and quality system activities required for cGMP pliance. This will enable the validated production, processing, storage and distribution of a range of sterile and nonsterile medicinal products under the control of an appropriate quality system. The VMP may be revised as appropriate to incorporate changes and/or additions to the facility and/or products.Using current pharmaceutical industry guidelines, the validation steps and activities will be designed to address all critical product attributes and process steps whilst minimising unnecessary work. This will be achieved by employing techniques such as Impact Assessment and risk assessment, in order to focus validation activity onto those systems critical to product quality.The validation process will follow these basic group headings:? Quality Plan? Design Reviews? FAT/Commissioning? Installation Qualification? SAT/Operational/Performance Qualification? Process Validation? Cleaning Validation? Analytical Method ValidationThe validation activities will be incorporated into project design, construction programs and production schedules. The objective of this is to integrate similar activities, . SAT with OQ, and thus reduce duplication of tests and checks to a minimum. Appendix D illustrates the relationship between project and validation stages.11 / 32 REGULATORY STANDARDS AND GUIDELINESThe following is a list of standards and guidelines deemed to be appropriate for this project. This list is not exhaustive and further regulations and guidelines will be used where appropriate. The list will be reviewed and revised as necessary whenever a new revision of the VMP is issued.1. New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Good, Part 1 – Manufacture of Pharmaceutical Products, 1993.2. New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Good, Part 3 – Compounding and Dispensing, 1993.3. New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Good, Part 3, Annex 1 – Compounding of Sterile Pharmaceutical Products, 1995.4. PIC/S Guide to Good Manufacturing Practice for Medicinal Products, 15th Jan 025. MCA Rules and Guidance for Pharmaceutical Manufacturers and Distributors, 2022.6. AS/NZS :2022 : Cleanrooms and associated controlled environments – Part 1: Classification and air cleanliness7. AS/NZS :2022 : Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued pliance with ISO 8. AS/NZS ISO :2022 : Cleanrooms and associated controlled environments – Part 4: Cleanrooms and associated controlled environments Design, construction and startup9. ISO EN :2022, Cleanrooms and Associated Controlled Environments – Part 5: Cleanroom Operations.10. ISO 146447:2022 : Cleanrooms and associated controlled environments Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)11. AS/NZS 4273(INT):1995A1 : Guidelines for the design, installation and use of pharmaceutical isolators.12. Pharmaceutical Isolators, 1st edition, 2022.13. ISPE Baseline Guide Volume 3, Sterile Manufacturing Facilities14. ISPE Baseline Guide Volume 4, Water and Steam Systems15. ISPE Baseline Guide Volume 5, Commissioning and Qualification16. BS 5295 Environmental Cleanliness in Enclosed Spaces17. European Pharmacopeia18. British Pharmacopeia19. The Quality Assurance of Aseptic Preparation Services, 3rd edition, 2022.20. Good Automated Manufacturing Practice.21. Good Laboratory Practice.12 / 32 DESCRIPTION OF PRODUCTS AND PROCESSES IntroductionThe pharmacy produces and issues a large number of products to inpatients, outpatients and other group hospitals/clinics.This VMP applies to all production processes in the pharmacy. Product GroupsProducts with similar characteristics and/or manufacturing processes have been placed into seven groups. A general process flow diagram (PFD) has been generated for each group (found in Annex A). Where significant differences occur within a group, these are identified in subsections within the PFD for the group.The seven product groups are:? Cytotoxics (dispensed, unlicensed manufacture)? TPN (dispensed, unlicensed)? CIVA (dispensed, unlicensed)? Terminally sterilised products (licensed manufacture)? NonSterile Products (unlicensed manufacture)? Repacking (dispensed)? Other (unlicensed manufacture)Please refer to schedule of products, product group descriptions and associated process flow charts located in appendix A.Whenever new products are to be processed by the pharmacy, then each will be assessed for inclusion into an existing group. Where this is inappropriate, . a significant new process is introduced, then a new group will be added, with supporting PFD and process descriptions. ProcessesFor each product group, the manufacturing processes and the specific equipment utilised will be described in detail. Specifically, these will include all processes critical to product quality. Processes that involve ‘standard’ operation of equipment, . weighing of product materials, may be simply listed and referenced to appropriate equipment SOPs. Product Storage and DistributionGenerally for pounded products, product storage time is relatively short, as most products are manufactured to meet prescription orders and in some cases have a sho