Checklist of Qualification and Control Documentation

Checklist of Qualification and Control Documentation

The FDA, as per existing cGMP regulations 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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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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