The meeting was organized by the Joint Pharmaceutical Analysis Group (JPAG), a society, founded in the 1960s that sets out to encourage, assist and extend the knowledge and study of pharmaceutical analysis and quality control.
Sterile pharmaceuticals need to be free of contaminating microorganisms, because the presence of such microorganisms could cause patient harm. Moreover, many of the patients in receipt of sterile medicines will have weak or compromised immune systems.
In order to explore how practices, standards and technologies can be brought together to enhance medicinal safety, JPAG brought together opinion leaders and experts from the UK regulator (the Medicines and Healthcare Regulatory Agency), the pharmaceutical industry and the National Health Service, together for a one day event.
The meeting opened with a presentation from the health regulator, looking at Good Manufacturing Practices (GMP) and forthcoming changes to regulations. This was delivered by Andrew Hopkins and it included a look towards forthcoming changes to European Regulations. One take-home message was that risk assessments should be used as part of building-in quality into processes and not simply as a tool to react to problems that have occurred.
The second presentation was from Yan Hunter-Blair (Newcastle-upon-Tyne NHS Foundation trust.) This presentation looked at isolator technology for the aseptic dispensing of medicines. Isolators are barrier systems that build a wall of protection around products and provide a clean-air supply over open vials. The presentation looked at how isolators can be sterilized and the key parameters for assessing this process.
The third presentation was delivered by Dawn Hiles (Newcastle Cellular Therapies Facility), who look at the problems of products that need to be used with patients before they can be satisfactorily tested for sterility. This placed an emphasis on the design and methods used to create clean spaces.
The lectures were inter-spaced with breaks and an opportunity to admire the Royal Society for Chemistry building, which includes several stained glass windows and a bust of Michael Faraday (the father of electromagnetism and electrochemistry.)
The fourth presentation was delivered by Dr. Aileen Hume who outlined models that can be used for assessing microbial contamination risks where medicines are formulated and dispensed. This theme was followed on with the fifth presentation from James Drinkwater, who presented a series of case studies for a sound microbiological testing regime.
The sixth presentation was from Dr. Tim Sandle, who looked at the best practices for investigating sterility test failures. The key message here was to run the investigation by taking into account both laboratory and process issues. With process issues the focus was with aseptic processing technology.
The final presentation of the day was delivered by Dr. Paul Newby, who presented some of the rapid microbiological methods and automated systems available designed to assess microbial contamination. These methods are intended to give more accurate results, in a faster time, through the use of more efficient automation.
