Publisher's Synopsis
This paperback book provides an introduction to Cleaning Verification and Validation for pharmaceutical and biological equipment and facilities. It provides a practical framework for the design and execution of cleaning validation. Cleaning Validation is a regulatory requirement as per GMP. There are many organisations and bodies which provide guidance of implementing a Cleaning Program such as PIC/s ICH, PDA reports, EU GMP V4 to name a few. The key elements to achieving a successful cleaning validation include (1) understanding the sources of residues (soils, excipients, actives, microbes etc) (2) developing a cleaning procedure (3) developing a test method (4) validating the cleaning procedure in respect of the products and equipment to be used in manufacturing.Summary of title indexIntroduction, What is Cleaning, Why Clean, Verification and ValidationDefinitions, Regulatory RequirementsFDA, EU GMP. ICH Q7, Validation Standards Stages of Validation, Stage 1 Process DesignStage 2 Process Qualification, Stage 3 Continued Process Verification, Validation General Principles and PracticesCleaning Validation Prerequisites to Cleaning Validation ExecutionValidation ReportClean In Place (CIP)Visibly CleanSoils and their behaviour DetergentsValidation StrategiesSummaryHow are Acceptance levels defined?Historical Context of LimitsUses of the term limitPDA Technical Report No. 29Calculation of MACO MACO for each piece of equipmentCleaning Validation ProtocolPIC/S Guidance on LimitsTest Methods ICH Q7 Validation of Analytical Methods DefinitionsCleaning Process DesignEquipment Considerations Cleaning Agent Approval Critical Cleaning Parameters Cleaning Pipes Dead LegsConnections and Tie-ins Valves Materials of Construction Pressure Testing SamplingDirect SamplingRinse Sampling Sources of Contaminants Utilities IntroductionKey Definitions Compressed AirWater Systems Clean SteamUseful References Appendix Precision Cleaning (Medical Devices)
