Improving Microbiological Control Of Non-Sterile Pharmaceuticals: Unlocking The FDA Guidance

 

The document is the first time that the FDA has pieced together a compliance framework for non-sterile medicines, and, in some ways, the document stands as a companion piece to the Aseptic Processing Guidance (issued in 2004, although in clear need of an update). The trigger for the non-sterile document was based on the pattern of non-sterile product recalls involving microbial contamination, based on the period 2014 to 2017 when 197 bacterial and fungal contamination events, associated with either the manufacture, packaging, shipping, or storage of the drug, were recorded.

 

 

This paper critically assesses the regulatory text.

 

For details, see:

 

Sandle, T. (2021) Improving Microbiological Control Of Non-Sterile Pharmaceuticals: Unlocking The FDA Guidance, Journal of GxP Compliance, 25 (6). DOI: https://www.ivtnetwork.com/article/improving-microbiological-control-non-sterile-pharmaceuticals-unlocking-fda-guidance

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Alternative method for sterilisation: X-rays

Compared with gamma, X-rays used for sterilisation have the highest potential penetration depth in a product. This advantage is off-set by the few number of X-ray generators available and less product validation or compatibility data being available. While the decontamination of products and materials with high-energy X-rays was developed during the 1970s, the first application of the technology for sterilisation (medical devices) did not begin until the early-2000s. 

 

 

The lower take-up may be about to change since interest in X-rays for sterilisation has increased in the 2020s following advances with higher beam power ratings of industrial electron accelerators. Along with e-beam and gamma radiation, three related-yet-different technologies are available.

 

Reference:

 

Sandle, T. (2021) Alternative method for sterilisation: X-rays, Staxs article, https://hubs.li/H0_LGcf0

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Microbiology meets AI: Pushing the boundaries of pharmaceutical science

 

Artificial intelligence is increasingly becoming an important component of microbiology within the pharmaceutical field. Researchers, microbiologists, laboratorians, and diagnosticians are interested in artificial intelligence based testing and analysis. 

 

This is for a variety of reasons, connected to drug analysis, pinpointing microbial weaknesses, improving the turnaround time, quality, and costs of testing, and so on. In addition, artificial intelligence has aided the prediction of drug targets, diagnosing microorganisms causing infectious diseases, classifying drug resistance against antimicrobial medicines, predicting disease outbreaks and exploring microbial interactions. 

 

Perhaps of greatest significance is where researchers are using machine learning algorithms for optimization of the best treatment indications for developing new medicines and as information sources to monitor and document the quality and impact of pharmaceuticals interventions.

 

 

This review article looks at some recent applications of artificial intelligence, taking place in 2021, within microbiology and as applied to pharmaceuticals.

 

Sandle, T. (2021) Microbiology meets AI: Pushing the boundaries of pharmaceutical science, Pharma Machines & Technology, 16 (5): 24 -23 at: https://pharmamachines.com/microbiology-meets-ai-pushing-the-boundaries-of-pharmaceutical-science/

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)