As the countdown to the New Year begins, we love to look back at what we have written over the past 12 months, and more importantly, which were the most read. Check out the top 5 most read articles from 2020.
- Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit
- Top 10 Pharma Inspection Findings from FDA, MHRA, and the Russian Drug Regulator
- State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector
- Former FDA Official David Doleski on Agency Hot Button Issues and Developing a Positive Relationship
- Part 1: Analysis of FDA FY2019 Drug GMP Warning Letters
1. Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit
Redica’s Senior GMP Quality Expert Jerry Chapman attended the International GMP Conference at the University of Georgia in Athens, Georgia in early March 2020. Here, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented a case study based on her experience.
Read the article here.
2. Top 10 Pharma Inspection Findings from FDA, MHRA, and the Russian Drug Regulator
Representatives from the U.S. FDA, UK MHRA, and the Russian regulator, SID&GP, presented on their agencies’ FY2019 inspection findings.
Read the article here.
3. State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector
2020 saw global regulatory agencies switch to virtual inspections in the face of the COVID-19 pandemic. At the virtual ISPE Biopharmaceutical Manufacturing conference, a representative from Thermo Fisher Scientific showed how new technologies can facilitate this new type of inspection.
Read the article here.
4. Former FDA Official David Doleski on Agency Hot Button Issues and Developing a Positive Relationship
At the ISPE Aseptic Conference held in North Bethesda, Maryland in early March 2020, David Doleski, formerly of the FDA, discussed how manufacturers can build better relationships with the agency.
Read the article here.
5. Part 1: Analysis of FDA FY2019 Drug GMP Warning Letters
Early in 2020, Barbara Unger, our Quality Expert, provided her analysis of the drug-related FDA Warning Letters issued in FY2019.
Read the article here.
As we roll into 2021, we are certain that these themes will only continue to grow in importance.
Which article did you find the most interesting? Let us know on LinkedIn!
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