Quality Management System for Active pharmaceutical

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Quality Management System - integrating GMP into ISOC.3 Qualification of equipmentC.3.1Design qualification should confirm and document the proposed design of facilities,equipment, systems etc., as suitable for the intended purpose.C.3.2Installation qualification should confirm and document that facilities, equipment,systems, etc., once installed or modified, comply with the approved design and themanufacturer’s recommendations.C.3.3Operational qualification should confirm and document that facilities, equipment,systems etc., as installed or modified, perform as intended throughout the anticipatedoperating ranges.C.3.4Performance qualification should confirm and document that performance is asintended when manufacturing the API.C.4 Validation documentationC.4.1There should be a written validation policy clarifying the circumstances under whichvalidation needs are to be identified; who is responsible for managing the validationprogramme; and outlining how validation should be conducted and documented.C.4.2Before commencing work, a validation plan should be drawn up defining validationobjectives; the process to be validated; the facilities, equipment, utilities, andsystems to be used; acceptance criteria; the persons responsible for conducting thework; those responsible for reviewing and approving the plan and reviewing theresults. The validation plan should be approved by managers with appropriateauthority in production and Quality Functions respectively.C.4.3Upon completion of the validation work, a validation report should be preparedsummarising findings, commenting on any relevant deviations, and drawingjustifiable conclusions. This report should be approved by assigned responsible staff.If the report concludes that validation has not been achieved, then it should proposechanges in order to achieve the validation purposes.C.4.4Validation records should be archived for a prescribed period of time, and beavailable if required.59
Quality Management System - integrating GMP into ISOC.5 Validation of computerised systemsC.5.1A computerised system should offer at least the same level of security as a manualsystem.C.5.2The extent of validation required will depend largely upon the use of thecomputerised system, but will also be influenced by the type of the requiredvalidation (prospective or retrospective) and whether or not novel features areincorporated.C.5.3Prospective validation should be undertaken for all new computerised systems andfor systems experiencing major upgrades. Existing computerised systems whichwere not validated at the time of installation may be more appropriate forretrospective validation.C.5.4Only configurable or specific application software should be considered as needingvalidation. Software with demonstrated market performance (operating andexecutive software) is normally not subject to validation.C.5.5Documentation supporting the validation of computerised systems should include:- user requirements- technical specifications- functional specifications- risk assessment on functionality- validation plan, protocol and report- change controlC.5.6Although general validation principles still hold good, validation of computerisedsystems is considered something of a specialist activity. Suppliers of computerisedsystems should be required to follow the principles laid down in- Quality Management and Quality Assurance Standards; Part 3: Guidelines for theapplication of ISO 9001 to the Development, Supply and Maintenance of Software(ISO 9000-3)- Good Automated Manufacturing Practice (GAMP) - Supplier Guide for Validationof Automated Systems in Pharmaceutical Manufacture.C.6 Cleaning validationC.6.1A guideline is presently being developed by CEFIC.60
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Quality Management System for Active pharmaceutical

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