【正文】 rt shelf life. When batch production is employed, batch size is managed to meet anticipated shortterm demand and hence avoid the need for longterm storage. Batch products with a prolonged expiry, raw materials and repacked products will be stored in a quarantine area before release for use, which will be a designated site in the cold room or storage area that is inaccessible.Products will be stored within a dedicated storage area. Where necessary, products will be stored in refrigerators or a cold room.There is a paper system for Inventory control.Products are delivered by a variety of routes dependant upon product and intended use. Generally they will be delivered in small lots, carried by hand, trolley, etc. to the end user. Returnable cold boxes will be used when a cold chain delivery is required.13 / 32 PROJECT DESCRIPTIONNote: All drawings referenced in this section are located in Appendix C. Site LocationThe new pharmacy is located on the site of the __________________. Its position with respect to other facilities on the same site is shown on layout drawing no. _____________. Facility Design and Layout.The facility consists of a _________________. Please refer to drawing no. _____________.The facility contains the production area. This is divided into 2 discrete clean room production suites termed zones 1, 2 and 3 according to the HVAC zoning.? Zone 1 _____________.Please refer to drawing no. _____________.There is a walkon ceiling level above the clean rooms within which piped services, HVAC ducting and electrical services are located.The plant room within which equipment such as Air Handling Units (AHUs), Water for Injections (WFI) generation, storage and circulation equipment, clean steam generator and control panels is situated in _____________. Please refer to drawing no. _____________. Production Suites Zone 1, NonSterile ManufacturingAll rooms classified GMP grade D. Please refer to schedule of room data sheets located in Appendix C. Served by HVAC zone 1. Please refer to drawing no. _____________.Processes undertaken in this area include:? Nonsterile manufacture of creams, ointments, suppositories, oral suspensions, oral liquids and capsules.? Extemporaneous preparation of creams, ointments and oral suspensionsPlease refer to process flow diagrams located in Appendix A.The zone is divided into 3 discrete areas and accessed by dedicated personnel change airlock number _______.:? Hazardous nonsterile product manufacture, including Dithranol/Coal Tar, flammables and cytotoxics. ? Prep 1, 2 and 3. Nonsterile product manufacture (nonhazardous). ? Equipment and bottle wash area. Pass boxes provide access for materials to local storage areas within preparation areas. Please refer to typical personnel, material, product and waste flow diagrams located in Appendix A. Zone 2, Preparation of Cytotoxic and Parental Nutrition ProductsRooms classified EU grades B, C and D served by HVAC zone 2. Additionally there is a small equipment store. Please refer to schedule of room data sheets located in Appendix C, and to drawing no. _____________.Processes undertaken in this area include:? Aseptic dispensing of parenteral nutrition products and aseptic dispensing of other parenteral items.14 / 32? Aseptic dispensing of cytotoxic chemotherapy? Aseptic manufacture of cytotoxic chemotherapyPlease refer to process flow diagrams located in Appendix A.The zone is divided into 4 discrete areas:? Grade D cytotoxic pounding area. Accessed by dedicated personnel change airlock number _______. Compounding of Cytotoxic products in grade A isolator.? Grade D cytotoxic materials disinfection and final check area, access……etc..? Grade D check and disinfection area, serving grade B pounding room. Personnel access via …….. Materials access via corridor and trolley transfer airlock.? Grade B area for pounding of Total Parenteral Nutrition (TPN) products in grade A laminar flow cabi. Personnel access via cascading grade B change. Materials access via hatch.Please refer to typical personnel, material, product and waste flow diagrams located in Appendix A.15 / 32 EQUIPMENT AND SERVICES TO BE VALIDATED Impact AssessmentIn order to simplify the validation and minimise unnecessary qualification activities, an Impact Assessment (IA) exercise will be carried out, following an approved procedure. This will enpass all equipment and services installed within the facility. It will define the validation requirements for equipment and services that are found to be critical to product quality and risk to patient.It is expected that equipment and services that are deemed noncritical will be installed, operated and maintained subject to Good Engineering Practice (GEP).Data from the IA should be used to provide information for use in the qualification protocols, such as critical instrument listings and acceptance criteria. IA will be considered for any change to established equipment and/or services in order to help define validation or revalidation requirements.Validation activities appropriate to the equipment and services may be considered at IA.The location of the IA results will be recorded and the data entered in a validation matrix attached to this VMP in appendix B. Risk AssessmentAppropriate Risk Assessments (RAs) will be carried out to identify and challenge all installation, operation, cleaning and maintenance processes.Processes that are identified as critical to product quality and risk to patient will be subject to Process Validation.Some processes may be identified as hazardous with respect to Health, Safety and Environmental (HSamp。E activities will be carried out. Generally this activity is outside the scope of this document. It is recognised, however, that some hazardous processes will involve validata