Pharmaceutical Water Systems.ppt

* | Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors, Nanjing, November 2009 Pharmaceutical Water Systems Alain Kupferman Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors, Nanjing, November 2009 FACTORS CONTRIBUTING TO QUALITY PRODUCTS Raw Materials Personnel Procedures Validated processes Equipment Premises Environment Packing Materials Water for Pharmaceutical Use PW HPW WFI CS PREREQUISITES FOR OPERATION AND (RE)QUALIFICATION As usual……Good designGood engineeringGood executionGood operationGood documentationandGood maintenance DEFINING THE NEEDS Regulatory (Pharmacopeia)PWHPWWFI EU ? PICS ? FDA ? User requirements Data on raw water DEFINING THE NEEDS: WHICH TYPE OF WATER WHERE ? Regulatory (Pharmacopeia)PWHPWWFI EU ? PICS ? FDA ? Regulatory (EMEA) DEFINING THE NEEDS: WHICH TYPE OF WATER WHERE ? GMP + GEP Drainability : slopes Flow speed In-process controls, sampling points Valves and accessories Size of generator(s) and storage tanks Critical parameters handling Etc. USER REQUIREMENTS Quantitative data: how much when ? Installation type: IE, RO, double RO, EDI Multi-effect, thermocompression,.. Loop type and storage: hot, cold, mixed, multiple fixed or variable speed pump deadlegs, valve types, … Sanitisation: heat, chemical, ozone Materials: stainless steel ? + treatment Heat exchangers: type Critical parameters handling I C R A I = Indicate C = Control R = Record A = Alarm Base for  instrumentation qualification QUALIFICATION ITEMS QUALIFICATION ITEMS IQ Inspection of mechanical installation and documentation (manuals, data sheets, components certificates) System installed in accordance with PI diagram Check of components (agree with description in components list) Gap between was