Always Follow Your SOPS! Upholding Gowning Requirements When Challenged by Inspectors
Regulatory inspections can be a stressful time for all involved. You may encounter some situations in which you are challenged by an investigator that goes…
Begin with the End in Mind for Technology Transfer for Cell Therapy Processes
In this interview, Dr. James Blackwell, Founder and Principal Consultant of The Windshire Group discusses cell therapy technology transfer "Communication and taking the time to develop…
Troubleshooting Bacterial Contamination in Bioreactors
One of the most dreaded problems in large scale biomanufacturing is contamination events. These events negatively impact an organization in many ways: lost batches and…
7 Ways to Reduce Chemistry Manufacturing Controls (CMC) Risk
Expedited Approval Pathways Increase Risk and Burden on CMC and Manufacturing: risk reduction strategies include earned value analysis and partnering. As discussed in a recent…
How to Implement Continued Process Verification (CPV) for Process Monitoring
ICH Q10 Guidance and Process Validation Guidance published by FDA in 2011 emphasizes both routine process monitoring and Continued Process Verification (CPV) as a key…
Establishing the Proper Stability Shelf-Life Claim: A Case Study
The client was a small, virtual company. They had one person responsible for CMC activities. Their initial request was, "can you just take a look…
Stability Data Analysis Product Case Study
The client knew that they needed to conduct statistical-based stability analysis for their product. They had stability data for 25 lots of drug product…
8 Biggest Mistakes in Conducting Deviation Nonconformance Investigations-Part II
This post, The 8 Biggest Mistakes In Conducting Deviation Nonconformance Investigations-Part II, discusses an additional 6 mistakes industry professionals need to avoid. 3. Not getting…
Pitfalls to Avoid For Determining a Product’s Shelf Life Q&A
In Pitfalls to Avoid For Determining a Product’s Shelf Life Q&A, The Windshire Group’s Chief Stability Scientist discusses Excel trending and the amount of time…
8 Biggest Mistakes in Conducting Deviation Nonconformance Investigations-Part I
This post, the 8 Biggest Mistakes in Conducting Deviation Nonconformance Investigations-Part I discusses the first two mistakes industry professionals need to avoid. Deviation investigations are…