As of March 4 2020, 16 of the last 50 recalls by the FDA for pharmaceutical products were due to microbial contamination or a lack of sterility assurance. Another 27 were due to impurities with 5 more due to mislabeling. Looking at TGA recalls for 2019, around half of the medicine recalls due to contamination were the result of microbial contamination. Continue reading
Tag Archives: FDA
What is Data Trending and How To Identify, Action and Report Trends
The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series.
Paul Yeatman is a microbiologist with over 15 years’ experience in documentation, validation and running investigations in TGA and FDA regulated environments. He has a strong interest in process improvement, documentation, training and developing others. From 9-5 Paul investigates and solves software problems. By night he works on his science chops. He has an arty streak, runs several blogs and enjoys communicating his experiences and knowledge in arenas such as this. Continue reading
Question regarding sterile filter hold time validation
The Question posed on LinkedIn:
“How to validate maximum hold time for product sterile filter after autoclave sterilization? Any link to regulatory guidelines is much appreciated.“
Life in the Lab – Microbiology Team Leader
Part of my Life in the Lab Series.
Here I summarise what each of my scientific roles have entailed.
As a Microbiology Team Leader (non sterile laboratory), what does the day entail?
08:30 hrs – Start shift Continue reading
Life in the Lab – Quality Assurance Microbiologist
Part of my Life in the Lab Series.
Here I summarise what each of my scientific roles have entailed.
As a Quality Assurance Microbiologist, what does the day entail? Continue reading
Life in the Lab – Senior Microbiologist aka “Microbiology Officer”
Part of my Life in the Lab Series.
Here I summarise what each of my scientific roles have entailed.
As a Microbiology Officer, what does the day entail?
08:30 hrs – Start shift Continue reading
Life in the Lab – Microbiology Analyst
Part of my Life in the Lab Series.
Here I summarise what each of my scientific roles have entailed.
As a Microbiology Analyst, what does the day entail? Continue reading
Life in the Lab – Microbiology Technician
Part of my Life in the Lab Series.
Here I summarise what each of my scientific roles have entailed.
As a Microbiology Technician, what does the day entail? Continue reading
Notes on the FDA’s Draft Data Integrity and Compliance With CGMP Guidance for Industry
Having worked in the pharmaceutical industry where I’ve dealt with electronic systems, paper based systems, programmed my own access databases and Excel spreadsheet and been on projects such as LIMS system validation, I figured I’d make notes on the FDA’s 2016 guidance for industry document regarding Data Integrity and Compliance With CGMP. This draft is for currently open for comment and the guidance addresses data integrity in:
- drug manufacture
- finished pharmaceuticals
- positron emission tomography drugs
FDA Guide To Inspections
A great reference for ensuring you are audit ready are the FDA’s Guide to Inspections documents and Guidance for Industry documents.
The FDA Inspection guides are freely available from here.
For my own reference and review, I’ve saved some of the Guidance for Industry documents below. However, you can get them all from this link.
- guidance for industry – investigating OOS test results for pharmaceutical production
- Guidance for Industry – general validation principles
- guidance for industry – q7a GMP for APII
- FDA-270-Guidance for Industry Sterile Drug Products Produced by Aseptic Processing
- FDA Guide to Inspections of HPW 4-27-07
- FDA guidance for industry – sterile drug products produced by aseptic processing
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