Hot microbiology discussions at Irish event

Pharmig Irish Conference: review The Pharmig (Pharmaceutical Microbiology Interest Group) Irish Conference took place at the Fota Island Hotel, near Cork, this week (June 14). The event was an opportunity for microbiologists and quality personnel from across Ireland and the UK to meet, listen to and discuss the important topics of interest to the pharmaceutical and healthcare sectors. The event opened with a presentation from Paul Moody of the Irish Medicines Board. In the presentation Mr Moody presented findings relating to the application of Annex 1 principles to biological drug substances and provided an overview of the Board's view of rapid microbiological methods, the latter part was of interest for those tasked with constructing validation protocols and who are seeking to offer alternatives to established pharmacopeia methods. Paul Moody concluded his presentation with a run through the main findings from IMB GMP inspections which had been conducted across Ireland during 2011. The common deficiencies included inadequate testing of culture media (failure to test each shipment) and poorly conducted sterility test investigations. The second speaker was Tim Eaton, of Astra Zeneca, who provided a useful case study relating to contamination control of cleanroom operations. The risk centric approach was based on a sound consideration of the sources of contamination found in cleanrooms, particularly the possibility of contamination transfer, and how this can be quantified. The third presentation was delivered by Scott Smith of Sanofi-Aventis. Mr Smith's presentation looked at how a QC microbiology laboratory can be run more efficiently and how the laboratory can and should relate to what actually happens in the areas where product is produced. The wide ranging and information presentation included the importance of relating contamination events to individual personnel - to create a sense of ownership - and the importance of understanding staff and what motivates them. Jane Wyatt, of Finefocus, continued with the risk theme by directing risk management towards the microbiology laboratory. Jane provided an invaluable schema for conducting gap analysis within the laboratory. For this, Jane explained, a detailed understanding of common non-compliances relating to microbiology was required. The conference held four open discussion sessions, which allowed the delegates to discuss and to share ideas. These were facilitated by five experienced practitioners. The sessions were on disinfectant efficacy, which was run by Kim Morwood of MGS Laboratories and Rachel Blount of Tristel; hot topics and themes coming out of various forums, facilitated by Edel Fitzmaurice of E. Fitzmaurice Associates; Developing a meaningful environmental monitoring programme, chaired by Karen Breen of Amgen; and various regulatory updates, relating to cleanrooms and sterility testing, co-ordinated by Dr Tim Sandle, representing Pharmig. Following the completion of the open discussions, the main conference resumed with the concluding two lectures. The first of these was by Tim Eaton, who discussed rapid microbiological methods. This was a useful lecture, debunking some of the myths that rapid methods are always better and reminding delegates that the application and validation of the method must be considered well in advance. The final presentation was from Dr. Tim Sandle. This presentation was on the revised USP chapter (1116) for the environmental monitoring of aseptic cleanrooms. In outlining the main changes, Dr. Sandle focused on the USP recommendation to move away from numerical action levels and towards an incident rate approach. It was noted that this could potentially result in a clash with EU GMP. The Pharmig Irish conference was a great success and the feedback from the delegates was excellent. The conference was professionally chaired by Edel Fitzmaurice and organized superbly by Pharmig's Maxine Moorey. For further details on Pharmig events, go Pharma Micro.