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
Share this Article/ Like It LinkedIn
Featured Article from: www.gmpviolations.com |
GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news.
If above Post not related to you please forward to your friends..because its CAREER Matter. Refer www.pharmanaukri.in
0 comments:
Post a Comment