Department ofContinuing Education
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Validation is an essential part of Good Manufacturing Practice (GMP) that provides a high degree of assurance that the equipment and or process will consistently perform as intended and stated in the pre-determined specifications. Validation work is mandatory and is regulated by the international organization such as FDA, EU and WHO guidelines. The course includes three main areas namely: Area (1) General Regulatory Guidance on Process Validation comprises: Validation terminology defined: key to communication - Effective Process validation based on the “Quality by Design” concept will lead to more in-process controls/continuous quality verification and the reduction of post-release testing - Cost of non-compliant process validation - Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. Area (2) Overview of new pharmaceutical facility qualification/validation covers: How to validate the following parameters as a pre-request for product validation raw materials - facility – equipment – environment. Area (3) Validation process includes: critical importance of corporate commitment to validation - Process Validation PV Policy/Program - The Validation Master Plan (VMP) Pre-Requisites: Facility/Utilities/Equipment Qualification: DQ/IQ/OQ/PQ.