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Sunday, February 5, 2017

FDA cGMP violations which teach about cGMP and effective CAPA system

FDA cGMP violations which teach about cGMP from where non GMP  activities went. Learn about effective CAPA system .

With this article we would like to share you about 4 FDA cGMP violations which teach about cGMP from where non GMP activities went. And we would learn about effective CAPA system and GOOD REGULATORY Response to warning letter?

Learn Observation 1: Focused on Cleaning of Equipment where the Product contacted to equipment which influences to probable contamination sources.

Observation: 1.    Failure to have adequate cleaning procedures to prevent contamination or carry-over material that would alter API quality.

Learn Observation 1: Investigator identified rust, insects, damaged interiors, and/or drug residues in pieces of manufacturing equipment

Due to deficient cleaning and maintenance practices present an unacceptable risk of introducing foreign contaminants, or cross-contamination between drugs.

Effective CAPA and GOOD REGULATORY Response to warning letter?

With respective to Observation 1 deficient in Equipment cleaning procedure and the lack of detailed investigations on observation and inadequate CAPA proposed influenced to warning letter..

cGMP, effective investigation and adequate CAPA as follows..!  

ü What are the root causes for rust? [Detailed investigation 5 whys/Fishbone analysis]
ü How insects enter in to clean room/classified area? [Detailed investigation 5 whys/Fishbone analysis]
ü Why/how damaged interiors? Why supervisor not identified? If identified why not taken action?
ü Why drug residues lying in equipment even after cleaning? [Detailed investigation 5 whys/Fishbone analysis]

The investigation can be done by step by step to conclude effective and detailed root causes to get rid off incidents/failures. And needs to be yield for effective correction and followed by Corrective action and preventive action. Before proposed preventive action should assess whether the decision shall meet 100% as expected and not influences again unexpected deviations with this decision. As write step by step detailed response to regulatory authority.  

By our next articles as below.

observation-2 (Failure of your quality unit to exercise its responsibility)
observation-3 (Failure to ensure all production deviations are reported)

observation-4 (Failure to ensure that test procedures are scientifically sound) 

Author: Mahender Nagaraju

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