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Report

October 13

Stability Challenges Post-Event Report

Thank you to the Royal Society of Chemistry for hosting a successful event by JPAG on Stability Challenges. Here, I will share with you some of the latest topics in industry that were highlights of the event.

The MHRA presented industry data on the following trends:

Stability Deficiencies in eCTDs

The number one deficiency in eCTDs filed with the MHRA was Insufficient stability data provided.  This results in the request for further data, whether it’s additional batches, additional testing or more time-points to support your application.

Other common deficiencies are inappropriate shelf-life specification acceptance limits, stability data not interrogated including extrapolation of data and the omission of photostability data or justification for missing data.

Stability Deficiencies in GMDP

For annual stability, common deficiencies found were inappropriate selection of batches, insufficient testing frequency, stability programmes not followed, stability samples not pulled or tested within the specified windows and temperature/humidity excursions in stability chambers not investigated appropriately.

Overall, the MHRA were extremely supportive in providing this feedback for industry as well as a few tips to take-away:

  • Stability programme and testing data is not just to generate data but to support the shelf life and storage conditions of products.
  • Out of spec results should be investigated and a full assessment should be conducted to identify risks to products currently on the market.
  • Stability studies should be designed to mitigate unknown events and to support extreme excursions that the product may experience.

ASAP Testing

Accelerated Stability Assessment Program (ASAP) enables scientists to determine substance stability and product shelf life. By using multi-dimensional analysis, scientists can accurately and comprehensively estimate stability.  An estimated shelf-life can be calculated through quantitative assessment of probabilities for each storage condition, and there are commercially available software packages that facilitate this for you.

Overall a great event and a useful source of information for any company involved in stability.

 

 

About the Author

Chris Allen started his career within Smith and Nephew Wound Management Division in 1997 after graduating from the University of Hull with a BSc (hons) in Chemistry and completion of a post graduate course in Analytical Science. Chris’ first role within the contract industry began in 1999 with Intertek Melbourn where he gained experience working alongside the world’s major pharmaceutical companies in the field of inhaled medicines. Chris moved to Yorkshire in 2002 to join Sciantec Analytical where he successfully developed the operational services of the Animal Health division, overseeing GMP certification for the laboratory. Chris joined Paul Moran as co-founder of Broughton Laboratories in 2006 and has held the position of Managing Director since 2011.