Assessing pharmaceutical quality control in Ireland

BY TIM SANDLE

Dublin – Assessing risks and removing contamination from the processing environment, even in lower classified areas to avoid product contamination, were the key messages at the annual meeting for pharmaceutical microbiologists in Ireland.
The gathering of pharmaceutical microbiologists, organized by the Pharmaceutical Microbiology Interest Group (Pharmig), a not-for-profit professional body, has been taking place in Ireland for over fifteen years. This year’s event took place at Portmarnock, a few miles outside of Dublin.
A view from Portmarnock May 2018.
A view from Portmarnock, May 2018.
Tim Sandle
Billed as a review of ‘hot topics’, the focus of the conference was on new regulations, removing environmental contamination, and with new approaches and technologies for solving contamination problems. The meeting was hosted by David Keeen, who is the current chair of Pharmig.
The opening address was delivered by Paul Moody, who is an inspector at the Irish regulatory agency – the HPRA. Moody presented on the latest update to the regulations that impact upon sterile pharmaceutical products. These requirements are contained within Annex 1 of the European Union Good Manufacturing Regulations. The main themes of the update were for each facility to have a contamination control strategy, embracing both chemical and microbiological risks, and for the international principles of Quality Risk Management to be adopted by healthcare and pharmaceutical organizations. Moody also explained that the door was open in terms of the adoption of rapid microbiological methods, most of which use digital technologies for data capture and which embrace an element of automation.
Conference delegates at the Pharmig Ireland annual meeting.
Conference delegates at the Pharmig Ireland annual meeting.
Tim Sandle
The second presentation was from Patrick Niewenhuizen, who is the Sterility Assurance Lead, Sanofi. This concerned the risk that fungal spores play to processing environments (and here some case studies were presented of the risk that fungi play in terms of potential product contamination). Niewenhuizen also presented some strategies for removing fungal contamination from processing areas.
A selection of microbiological culture media for the cultivation of bacteria and fungi.
A selection of microbiological culture media for the cultivation of bacteria and fungi.
Tim Sandle
The third presentation came from Tim Sandle, and this was an overview of culture media practices (with the media used to capture and grow microorganisms either in the environment or laboratory setting). The practices presented were drawn from a survey of Pharmig’s membership. This was followed by a presentation delivered by Paul Newby, who is a manager at GlaxoSmithKline focusing on Future Analytical and Control Technologies. Newby discussed the subject of water activity, which is about ‘available water’ in medicines. Newby outlined a process that could reduce direct microbiological testing if technologies are used to assess the available water in pharmaceutical preparations and by risk assessing which microorganisms, identified as being at risk, may or may not grow in particular products.
A real-time particle counter an example of one of the rapid microbiological methods on show.
A real-time particle counter, an example of one of the rapid microbiological methods on show.
Tim Sandle
Newby also deivered the next presentation which was on rapid and alternative microbiological methods which could replace a conventional method for assessing product sterility. The complexities of validation and the key requirements for presenting the information to regulators were set-out. This was followed by a presentation of an alternative rapid microbiological method by Susan McDonagh. This looked at a device for incubating plates, counting them through a digital camera, analyzing and then storing data. A key advantage of the device was to address data integrity and security concerns.
Jim Polarine addressing the Pharmig conference.
Jim Polarine addressing the Pharmig conference.
Tim Sandle
David Keen, who is a Global Microbiology Consultant at Ecolba, delivered the penultimate presentation, looking at strategies for microbial identification and the different technologies that are available. Getting the balance just right in terms of when to identify, how often, and to which level, were put to together as the essential for the strategy. The final presentation of the day came from Jim Polarine, who works for Steris. This talk covered disinfectant efficacy assessments and presented a path to follow to help make sense of the different global, and at times, competing standards. A useful overview of current regulatory concerns was also included.
Conference delegates relaxing after the event within the Portmarnock Hotel.
Conference delegates relaxing after the event, within the Portmarnock Hotel.
Tim Sandle
In terms of overall themes, a more detailed approach to risk assessment was evident, together with discussions centered on the tools and mindsets to achieve these objectives, and consideration as to how emerging technologies can assist in meeting these objectives.

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