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.

Subpart Subpart Section of CGMPs Qualification and control documentation
A General provisions
B Organization and personnel Responsibilities of the quality control unit
C Buildings and facilities Plant and facility installation and qualification

Maintenance and sanitation

Microbial and pest control

D Equipment  Installation and qualification of equipment and cleaning methods
E Control of components, containers and closures  Incoming component testing procedures
F Production and process controls Process control systems, reprocessing control of microbial contamination
G Packaging and labeling controls Dehydrogenation, sterile packaging, filling and closing, expire dating
H Holding and distribution Warehousing and distribution procedures
I Laboratory controls Analytical methods, testing for release

component testing and stability testing

J Records and reports Computer systems and information systems
K Return and salvaged drug products Batch reprocessing


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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 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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