Checklist of Qualification and Control Documentation

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 personnelResponsibilities 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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