Transcription of CLEANING(VALIDATION:( BASIC(PRINCIPLES(
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CLEANING(VALIDATION:( BASIC(PRINCIPLES(
Pharmaceutical Consultancy Services, All rights validation : BASIC principles Pharmaceutical Consultancy Services, All rights cleaning validation ? Any cross- is considered unacceptable Some cross- are known to be , penicillins, cytotoxics Other cross- may have unpredictable effects, , cross- Cross- could affect the performance of the product, stability THEREFORE .. cleaning is necessary to demonstrate that the methods used to clean manufacturing equipment are adequate to ensure that the risk of cross- is acceptably low. Pharmaceutical Consultancy Services, All rights CONTAMINANTS Product residues cleaning agent residues and breakdown Airborne maJer Lubricants, ancillary material residues Bacteria, mould and pyrogens SOME OR ALL MAY NEED TO BE CONSIDERED, BASED ON RISK ANALYSIS Pharmaceutical Consultancy Services, All rights FOR A cleaning validation STUDY STANDARDISED
requirements(foracleaning(validation(study(standardised cleaning method sop validated quantitative sampling method (i.e. swab) validated analytical method in range to be measured validation study can begin
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