Homework 6 – Process Controls and Documentation / Control of microbiological con
ID: 55881 • Letter: H
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Homework 6 – Process Controls and Documentation / Control of microbiological contamination Warning Letter to Apotex, Inc. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344476.htm Whole class: Summarize all cGMP violations by Apotex emphasizing specific violations. What test is done to demonstrate unidirectional air flow that is required of an aseptic manufacturing facility? Be sure to describe violations that are related to product defects and deviation/ discrepancy investigations that were covered in the last lecture. Homework 6 – Process Controls and Documentation / Control of microbiological contamination Warning Letter to Apotex, Inc. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344476.htm Whole class: Summarize all cGMP violations by Apotex emphasizing specific violations. What test is done to demonstrate unidirectional air flow that is required of an aseptic manufacturing facility? Be sure to describe violations that are related to product defects and deviation/ discrepancy investigations that were covered in the last lecture. Homework 6 – Process Controls and Documentation / Control of microbiological contamination Warning Letter to Apotex, Inc. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344476.htm Whole class: Summarize all cGMP violations by Apotex emphasizing specific violations. What test is done to demonstrate unidirectional air flow that is required of an aseptic manufacturing facility? Be sure to describe violations that are related to product defects and deviation/ discrepancy investigations that were covered in the last lecture.Explanation / Answer
violations by Apotex emphasizing specific violations
1). Failure to thoroughly investigate the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed
2).Failure to submit NDA/ANDA field alert reports (FARs) in the required timeframe, within 3 working days of becoming aware of information concerning any significant chemical, physical, or other change or deterioration in the distributed drug product
3).Failure to include a specimen or copy of each approved label and all other labeling in the master production and control record
An in situ air pattern analysis should be conducted in all critical areas under dynamic conditions, to demonstrate unidirectional airflow and sweeping action at critical work areas.
These studies should evaluate the impact of aseptic manipulations (e.g., interventions) and equipment design, document the activities performed, and include written conclusions.
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