Quality Management System for Active pharmaceutical

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Quality Management System - integrating GMP into ISOB.1.9Equipment surfaces in contact with materials used in API manufacture should benon-reactive.B.1.10Equipment should be clearly and uniquely identifiable, as should be its status.B.1.11Disposal of solid, liquid or gaseous by-products should comply with localenvironmental protection requirements.B.1.12Plant security should be sufficient to prevent unauthorised persons from gainingaccess to API manufacturing facilities.B.2 Computerised systemsB.2.1Quality critical configurable and specific computer software should be validated.This validation should include a full description of the programme and a chartrelating the various main and sub-programmes. Well tried operating systems andsoftware with demonstrated market performance require a different level ofvalidation.B.2.2The validation should concentrate on those aspects of the programme that affect orcould affect product quality.B.2.3Computer systems should be designed and operated to prevent unauthorised entriesor changes to the programme.B.2.4In the case of manual entry of quality critical data there should be a secondindependent check to verify accuracy of the initial entry.B.2.5A back-up system should be provided of all quality critical data.B.2.6There should be written operating procedures describing:- the operation of the system- the action to be taken in case of malfunction- the means of detecting, recording and correcting errors- the process for re-starting, and recovery of data- change control- the use of electronic signaturesB.2.7Incidents that could affect the quality of API or the reliability of records or testresults should be recorded and investigated.55
Quality Management System - integrating GMP into ISOB.3 CleaningB.3.1Buildings should be maintained in a clean condition and cleaning procedures shouldbe documented and readily available.B.3.2Equipment should have product contact surfaces that are easily cleanable.Connections between various pieces of equipment should also be easily cleanable.Items that are difficult to clean in situ should be dismantled whenever there is apotential for contamination.B.3.3There should be written procedures describing the cleaning of equipment includingrelated equipment such as heat exchangers or connections. There should be a recordthat the cleaning activity has been completed and the cleanliness status of theequipment should be identifiable. Where appropriate, the cleaning procedures shouldbe validated (see Annex C).B.3.4Cleaned equipment should be protected from re-contamination. It should bechecked for cleanliness before use and the result of this check should be recorded.B.3.5Whilst clean-up between successive batches of the same API is not mandatory,equipment should be cleaned at appropriate intervals when the risk of contaminationfrom microbiological growth or non-acceptable material build-up becomes too great.B.3.6Sampling tools and containers should be maintained in a clean condition so as toprevent contamination of both the sample taken and the material being sampled.B.4 UtilitiesB.4.1Quality critical utilities (e.g. water, steam, air, nitrogen) should be validated andfrequently monitored. Action should be taken when defined warning levels arereached.B.4.2Chemical and microbiological specifications should be established to control waterquality (e.g. potable water; heated water; endotoxin-free water; steam). Waterquality should be monitored during quality critical manufacturing steps.B.4.3Pipework and valves should be designed to minimise the risk of contamination.Permanent pipework should be labelled with the name of the material therein and thedirection of flow, and should be located so that rusting, surface condensation, orleakage will not lead to contamination.56
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Quality Management System for Active pharmaceutical

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