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Introduction
1. Installation qualification
=>> Facilities
=>> Utilities
=>> Equipment
2. Operation qualification
=>> Testing Protocols for Utilities and Equipment
3. Validation
=>> Testing protocols for products and Cleaning systems
4. Documentation
5. Validation of the QA testing laboratory
6. SOPs
7. Training of personnel
8. Organization charts
9. Schedule of events
When an organization follows the precepts of total quality management (TQM), the concept of continuous improvement would routinely be used.
When process validation is used as a quality assurance tool instead of a final examination, an organization’s operations will improve or stay at the highest quality level possible. The effort will be properly documented, and the overall attitudes of all the affected personnel will be positive. Finally, a more logicalapproach to pre approval inspections and other FDA technical interactions will be affected.
When the validation activity becomes the focal point of an organizational unit’s effort to carry out its own technical responsibilities, quality standards will be maintained for the product and manufacturing process from the design and development stages and throughout the commercial life of the product.
The concept of validation had to be redefined and re-evaluated to accommodate the technical changes. Traditional validation concepts and procedures that were acceptable years ago may no longer be applicable to today’s operations and equipment.
A practical understanding of the validation concepts and when and how to apply them is of greater importance to ensure a meaningful, efficient, effective, and economical validation program. Because practicality and compliance are both important aspects of validation. Finally, as with any project, the validation is not complete without the necessary documentation. Special attention should be afforded to the physical appearance of the report, as well as its technical contents.
