Pharmaceutical Industry Performance Metrics
Dr. Ajay Babu Pazhayattil
Vice President | Pharmaceutical Management Consultant | Validation, Quality, Technical Operations Leader | Author | 24K+
1. US FDA 483’s: 2017 > 2018 > 2019
The monthly mean of FDA 483 observations are trending downwards year over year: 241 > 204 > 173. But that does not mean it’s all great, read below to get a feel for the real root of current quality problems!
2. The top 10 21 CFR Part 211 (cGMP) sections that yielded the greatest number of 483 observations:
> 50% of the top 10 observations were related to the Quality Unit's (QA, QC) direct job functions!
3. Total # of site 483 observations where CFR Title 21, 211.22 (Quality Unit responsibility) was also cited:
The site’s overall audit performance was found to be adversely impacted where the site's Quality Unit (CFR Title 21, 211.22 ) was cited!
Are you putting technically competent people in front of auditors? Is your Quality Unit your Quality problem? Is it time for a Quality Culture shift starting with the introspection of your Quality Unit? Do you ever challenge your Quality Unit capability?
https://www.biopharminternational.com/view/solving-pharma-s-quality-unit-identity-crisis
Manager Process Validation
11 个月Thanks for sharing!
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3 年Ajay, thanks for sharing!
Regulatory Lead | Collaborative Business Partner | Board Member
4 年#quality
sales manager hardcore Pharma professional having 28 years' experience pharmaceutical Products
4 年thanks for enlightening
Consultant
4 年Thanks for posting