蒸汽灭菌和冻干工艺的验证及风险分析.pptxVIP

VALIDATION and RISK ANALYSISSteam Sterilization and Lyophilizzation ;CONTENT;GMP VALIDATION;Extracted from the ROSENHEIM Report The AIR was not properly removed from the chamber The drain of the chamber was blocked by pieces of glasses The lower section of the load did not reach the sterilization temperature The temperature recorder showed this anomaly but people thought it was not working properly Sterility tests were carried out only on the upper layers of the load;Validation;Terminal Moist-Heat Sterilization;Validation;CONTENT;What is being Sterilized?;Defining the sterilization process;BIOBURDEN Thermic resistance of the product;Balance must be Maintained;Defining the sterilization process;CONTENT OF THE PRESENTATION;Validation;?Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics? (FDA Guideline on General Principles of Validation, 1987) ?Validation is a defined strategy of inter-related practices and procedures which in combination with routine production methods and quality control techniques provides documented assurance that a system is performing repetitively as intended and/or that a product conforms to its pre-determined specifications (PDA TM#1 revised, Draft 13, Glossary);Common items: - Specify - Document - Verify the effectiveness - Verify the reproducibility The scope of validation is the process or the product The new PDA definition considers validation as a “ongoing process” (maintaining the validated status);Process;Stages of the qualification of a piece of equipment should include DQ, IQ, OQ and PQ.;DESIGN QUALIFICATION ;DESIGN QUALIFICATION ;“Installation Qualification is an essential step preceding the Process Validation exercise. It is normally executed by the Engineering group. The installation of equipment, piping, services and instrumentation is