Checklist of Qualification and Control Documentation
The FDA, as per existing cGMP regulations and considers process validation necessary because it makes good engineering sense.
Organization and personnel – Responsibilities of the quality control unit
Buildings and facilities :
- Plant and facility installation and qualification
- Maintenance and sanitation
- Microbial and pest control
Equipment : Installation and qualification of equipment and cleaning methods
Control of components, containers and closures –Incoming component testing procedures
Production and process controls – Process control systems, reprocessing control of microbial contamination.
Packaging and labeling controls – Dehydrogenation, sterile packaging, filling and closing, expire dating
Holding and distribution : Warehousing and distribution procedures.
Laboratory controls : Analytical methods, testing for release & component testing and stability testing.
Records and reports : Computer systems and information systems.
Return and salvaged drug products :Batch reprocessing
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