Critical Parameters Affecting Process Validation
Critical Parameters Affecting Process Validation
Critical Parameters Affecting Process Validation
Validation is an integral part of quality assurance; it involves systematic study of systems, facilities and
processes aimed at determining whether they perform their intended functions adequately and
consistently as specified. Validation in itself does not improve processes but confirms that the
processes have been properly developed and are under control. Adequate validation is beneficial to the
manufacturer in many ways It deepens the understanding of processes; decreases the risk of
preventing problems, defect costs, regulatory non compliances and thus assures the smooth running of
the process.
developed. The completion of a successful Operational Qualification should include the finalization of
operating procedures and operator instructions documentation for the equipment.
Performance Qualification combines the actual facility, utilities, equipment, trained personnel, control
procedures and components to produce commercial batches. Performance qualification will have a
higher level of sampling, additional testing and greater scrutiny of process performance. The level of
monitoring and testing should be sufficient to confirm uniform product quality throughout the batch
during process.
5. Conclusion
Process validation is a mean of ensuring and documenting that the processes are capable of producing a
finished product of the required quality consistently and should cover all the critical elements of the
manufacturing process. The process design stage and the process qualification stage should have as a
focus the measurement system and control loop establishing scientific evidence that the process is
reproducible and will consistently deliver quality products.
Good process design and development should anticipate significant sources of variability and establish
appropriate detection, control, appropriate alert and action limits. Process variability should be
periodically assessed. It is the responsibility of the manufacturer to judge and provide evidence of a
high degree of assurance in its manufacturing process.
6. References
Guidance for Industry Process Validation: General Principles and Practices US Dept. of
Health and Human Services, Food and Drug Administration. Nov. 2008 Current Good
Manufacturing Practices.
ANNEX 15. Validation Master Plan, Design Qualification, Installation and Operational
Qualification, Non Sterile Process Validation, Cleaning Validation. 17th Sep. 1999.
7. Author
Rajkumar P. Patil
Sr. Production Officer
Mobile No. +919945642935
Mail ID. [email protected]