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(4)Validation and Qualification

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allelipraise's version from 2018-06-06 15:16

Section 1

Question Answer
Validationa documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre- determined acceptance criteria
Process Validation (PV)a documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or API meeting its predetermined specifications and quality attributes
Prospective Validation should be completed before the commercial distribution of the final drug product manufactured from that API; preferred approach
Concurrent Validationcan be conducted when data from replicate production runs are unavailable.
Retrospective Validationcan be conducted for well- established processes that have been used without significant changes to API quality due to changes in raw materials, equipment, systems, facilities, or the production process
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Section 2

Question Answer
Qualificationaction of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results
Design Qualification (DQ)documented verification that the proposed design of the facilities, equipment or systems is suitable for the intended purpose
Installation Qualification (IQ)documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements
Operational Qualification (OQ)documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges
Performance Qualification (PQ)documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications
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