美国FDA验证高级培训.pptx

;目录Table Of Contents;;What is Validation?;Validation;Validation Is.....;To Consistently Produce A Desired Known Product;;First three steps to CGMP compliance;Boundaries of Validation;Validation Life Cycle Approach;Validation Life Cycle Approach;Benefits of Validation;Elements Of Contemporary Validation In The US;cGMP and ISO-9000 - Similarities;cGMP and ISO-9000 - Differences;Benefits of the Systems Approach to Validation;The Validation Program;Part Two: GMP Requirements;GMP requirements;cGMP in the Pharmaceutical Industry;Regulatory Requirements for Validation.....;GMP Regulatory Requirements for Cleaning Validation;GMP Regulatory Requirements for Test Method Validation;GMP Regulatory Requirements for Test Method Validation;GMP Regulatory Requirements for Test Method Validation;PROCESS VALIDATION;Part Three: History and Expectations;History and expectations;Validation Targets;History of Validation;validation vs. VALIDATION;Elements of Contemporary Validation in the US;Expectations;Part Four: Validation;Who Validates?;Validation;Validation;Validation;Write Protocols;Example Data Sheets;Conduct Testing;Installation Qualification (IQ);Operational Qualification (OQ);Process Qualification (PQ);Definition of Process Validation;Definition of Process Validation;Stages of the Life-Cycle;Benefits of Validation;Documentation of Validation;Validation Protocols;Validation Protocol Essential Elements;Validation Reports – Functions;Validation Report - Contents;Installation Qualification (IQ);Design Documentation;Construction Documentation;The PID;Operational Qualification (OQ);Process Qualification (PQ);Review and Approvals;Part Five: Validation Master Planning;Planning;Existing Plants;Master Plan;Facilities, Processes or Products;Master Plan - General;Master Plan - Why;Master Plan - What;Master Plan - Getting Started;Master Plan – Facility Description;Master Plan - Process Description;Master Plan - Process Control;Master Plan - Validated Systems;Master Plan - Procedure