Definition
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Validation Validation of an activity is the provision of documented evidence that the activity function in accordance with its design and will continuously produce the intended result with in the predefined specification.
Goals of Process Validation. The goals of are to determine the Suitability of the process. Uniformity of the process Reproducibility of the process
Types of Validations Prospective Validation: The documented evidence, prior to a process implementation, that a process does what it purports to do based on a validation master plan. All new facilities or operations must be validated before release of product. Retrospective Validation: The documented evidence that a process does what
it purports to do based on review and analysis of historical information. Existing facilities and operations that have not been prospectively validated must be assessed against an approved Validation Master Plan and appropriate action initiated. Concurrent Validation: The documented evidence that a process does what its purports to do based on information generated during actual implementation of the system.
Out line of Validation Activity 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.
Validation Master Plan Validation Plans Responsibility Validation Protocols Equipment Qualifications Equipment Calibration Documentation Standards Operating Procedures Deviations Change Control Validation Report Documents Retention & Retrieval
Benefits of Validation Most common deficiencies cited during Quality Audit/Inspections are: Laboratory Controls
15%
Equipment Cleaning
14%
Process Controls
13%
Decimation
11% 9%
Water System
9%
Others
25%
Validation helps in reducing the number of batch rejected/recalls. Reduce cost by reducing cycle time. Supports in gaining market reputation and leadership. It gives a higher quality, more uniform and reproducible products. Develops confidence among the patients and health profession. Boosts employee morale and motivation.
Conclusion The concept of Validation is of vital importance in cGMP. Variations due to materials, machines, methods and men should be properly evaluated and controlled so as to produce products of consistent quality.
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Goals of Process Validation. The goals of are to determine the Suitability of the process. Uniformity of the process Reproducibility of the process
Types of Validations Prospective Validation: The documented evidence, prior to a process implementation, that a process does what it purports to do based on a validation master plan. All new facilities or operations must be validated before release of product. Retrospective Validation: The documented evidence that a process does what
it purports to do based on review and analysis of historical information. Existing facilities and operations that have not been prospectively validated must be assessed against an approved Validation Master Plan and appropriate action initiated. Concurrent Validation: The documented evidence that a process does what its purports to do based on information generated during actual implementation of the system.
Out line of Validation Activity 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.
Validation Master Plan Validation Plans Responsibility Validation Protocols Equipment Qualifications Equipment Calibration Documentation Standards Operating Procedures Deviations Change Control Validation Report Documents Retention & Retrieval
Benefits of Validation Most common deficiencies cited during Quality Audit/Inspections are: Laboratory Controls
15%
Equipment Cleaning
14%
Process Controls
13%
Decimation
11% 9%
Water System
9%
Others
25%
Validation helps in reducing the number of batch rejected/recalls. Reduce cost by reducing cycle time. Supports in gaining market reputation and leadership. It gives a higher quality, more uniform and reproducible products. Develops confidence among the patients and health profession. Boosts employee morale and motivation.
Conclusion The concept of Validation is of vital importance in cGMP. Variations due to materials, machines, methods and men should be properly evaluated and controlled so as to produce products of consistent quality.
Select/Jump Other Service
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