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The activities relating to validation studies may be classified into three phases:
Phase 1: Pre-Validation Phase or the Qualification Phase, which covers all activities relating to product research and development, formulation, pilot batch studies, scale-up studies, transfer of technology to commercial scale batches, establishing stability conditions, storage and handling of in-process and finished dosage forms, Equipment Qualification, Installation Qualification, master production documents, Operational Qualification, Process Capability.
Phase 2: Process Validation Phase (Process Qualification phase) designed to verify that all established limits of the Critical Process Parameters are valid and that satisfactory products can be produced even under the “worst case” conditions.
Phase 3: Validation Maintenance Phase requiring frequent review of all process related documents, including validation audit reports to assure that there have been no changes, deviations, failures, modifications to the production process, and that all SOP’s have been followed, including Change Control procedures and qualifying systems ,equipments are required to qualify for following Qualifications:
1.Design qualification (DQ)
2.Component qualification (CQ)
3.Installation qualification (IQ)
4.Operational qualification (OQ)
5.Process qualification (PQ)
Design Qualification (DQ)– It consists process of gathering documentary evidence of a particular instruments or machine’s fundamental operational and functional specification of an instrument , and its inherent program , or equipment and details about and its detailed design and its qualifications , why this instrument and is supplier chosen.
Installation Qualification (IQ) – It consists process of gathering documentary evidence and process of Demonstration that the process or equipment being installed complies with all of its qualifications of successful installation in a particular aria , so as to comply with intended requirements of process , with respect to its specifications, is it installed correctly, are all necessary accessories and components installed correctly and its documentation required for continued utilization are installed properly.
Operational Qualification (OQ) – It consists process of gathering documentary evidence and of Demonstration of all aspects of a equipment , process are functioning properly and accurately so as to yield intended ,measurements, results quality of a pharmaceutical being manufactured.
Performance Qualification (PQ) – It consists process of gathering documentary evidence and process of Demonstration of all aspects of a equipment , process are functioning properly and accurately so as to produce intended ,measurements, results , intended quality of a pharmaceutical manufactured over a period of time. in a consistent manner.
