Review of FDA Warning Letters to Pharmaceuticals: Cause and Effect Analysis

[...]CGMP rules in essence ensure the safety of a product3. Pareto analysis of poor quality system (Fig 7) revealed that cause of 80% of this category of the observation is due to Inadequate investigation, Role of Quality unit is not defined as required by CFR part 210, SOP not available / Inadequat...

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Bibliographic Details
Published in:Research journal of pharmacy and technology 2018-07, Vol.11 (7), p.3219-3226
Main Authors: Jain, Sanjay Kumar, Jain, Rajesh Kumar
Format: Article
Language:English
Subjects:
Good Manufacturing Practice
Investigations
Manufacturing
Patient safety
Quality standards
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Summary:[...]CGMP rules in essence ensure the safety of a product3. Pareto analysis of poor quality system (Fig 7) revealed that cause of 80% of this category of the observation is due to Inadequate investigation, Role of Quality unit is not defined as required by CFR part 210, SOP not available / Inadequate SOP, Inadequate stability program testing of finished product not performed and Poor documentation practice. 4.2 DATA INTEGRITY BREACH: Following steps shall be taken to build quality culture in the organization, suggested by senior industry person during the interview - * Emphasis on quality by senior leaders * Increasing employee oversight and empowerment * Reward and recognise quality excellence * Establish environment of Trust and collaboration * Science based decision making His message to other industry friends to ensure compliance and avoid such notices (Warning letter and import alert) were as below - * Do automations to the extent positive to avoid human errors and ensure reproducibility (less variation) of the process * Recruitment of right people, their training and engagement to retain. * Focus about data integrity issues in all the functions like laboratory, production, engineering, warehouse etc. * Facilitate continual improvement * Science based decisions FDA warning letters are available on FDA website as electronic data and can be accessed by anyone. Guidance for Industry, Data Integrity and Compliance With CGM, Draft Guidance, U.S. Department of Health and Human Services Food and Drug Administration, April 2016, Pharmaceutical Quality/Manufacturing Standards (CGMP)
ISSN:0974-3618
0974-360X
0974-306X
DOI:10.5958/0974-360X.2018.00592.9