The event was held at a hotel in Nottingham (the Belfry) and it was the 24th conference held by the Pharmaceutical Microbiology Interest Group (Pharmig.)
The conference opened with an address by a representative of the U.K.’s pharmaceutical products regulator (the Medicines and Healthcare products Regulatory Agency — MHRA). The presentation was delivered by Andrew Hopkins. The focus was on the forthcoming revision to the guidance for the manufacture of sterile pharmaceutical products. Such products are generally administered to very ill people, who often have weak or compromised immune systems.
The second presentation of the first day was on the subject of data integrity. This largely concerns computer systems, such as systems used for recording the results of laboratory assays (and where the results contribute to the overall assessment of whether a drug product is both safe and efficacious). This was delivered by Julie Roberts, a pharmaceutical consultant. In some regions of the world fraudulent practices have taken place where data has been changed, and this has led to an increased focus from regulatory bodies (such as the U.S. Food and Drug Administration). Unintentional compromises to data can also occur through system data losses.
The next presentation was delivered by U.S.-based microbiologist Dr. Tony Cundell. Dr. Cundell, who sits on the microbiology working group for the United States Pharmacopoeia, looked at the safeguards around pharmaceutical compounding. In recent years, compounding centers have been hit by various quality issues, including the need for product recalls due to microbial contamination issues. The most infamous of these was the New England Compounding Center, where a fungal contamination incident of a sterile injection product intended to treat arthritis led to the deaths of 64 people and caused life-changing injuries to over 700 more. This incident was extensively covered by Digital Journal. Dr. Cundell explained that while progress had been made, greater vigilance was required.
The fourth presentation was on advances in laboratory technology in the form of rapid microbiological methods. This was delivered by Dr. Paul Newby of GlaxoSmithKline. Rapid microbiological method technologies aim to provide more sensitive, accurate, precise and reproducible test results when compared with conventional, growth-based methods. Rapid methods normally involve some form of automation, and the methods often capture data electronically.
The fifth presentation, by Dr. Kevin Wright (Procter & Gamble), considered how methods can be transferred between different laboratories without any technical hitches. The sixth, and final presentation of the first day, was a case study from Public Health England. Here Dr. Bharat Patel gave the background into a series of deaths of newborn babies in Northern Ireland in 2011-2012. The cause was due to a bacterium called Pseudomonas aeruginosa, and the organism had colonized the water systems of several hospitals in Belfast. The case study included some important lessons to be learned.
Inter-spaced between the presentations were workshops. The subjects included data integrity, where Julie Roberts built upon her presentation; improving cleaning and disinfection practices, hosted by Laura Guardi and Rachel Blount; and an expert corner, run by Andy Martin and Andy Brack. An additional session was held by this writer on the quality of culture media. Culture media is of fundamental importance for most microbiological tests: to obtain pure cultures, to grow and count microbial cells, and to cultivate and select microorganisms. Without high-quality media, the possibility of achieving accurate, reproducible, and repeatable microbiological test results is reduced.
The following day of the conference was opened by a second lecture from Dr. Cundell. This concerned the safe testing of non-sterile pharmaceutical products (such as an inhaler or tablet.) Some sound advice for screening for so-called ‘objectionable’ microorganisms was offered.
The second presentation of day two was from Laura Guardi, who works for the global company AstraZeneca. This provided some best practice guidance on the validation of disinfectants. Keeping the environment within which pharmaceutical products are manufactured in control, and with a low level of microorganisms, is critical to product quality and this can be achieved through the use of appropriate disinfectants. To know whether a disinfectant is suitable requires validation.
This was followed by a presentation by Dr. Anna Lovatt on the selection of microbial identification systems and the appropriate strategy for characterizing microbial contamination. Characterizing a microorganism can provide important information as to its origin and potential impact in relation to a product or in relation to the environment in which it was isolated.
The penultimate presentation of the conference was delivered by Edel Fitzmaurice, a consultant microbiologist based in Ireland. This looked at the optimal means for designing risk assessment for the safe production of pharmaceutical products. The conference closed with a lecture by Peter Gough (of the company NSF) on the impact of Brexit on the U.K. pharmaceutical industry. Here the outcome remains uncertain.
The conference succeeded in emphasizing the importance of risk assessment to keep pharmaceutical medicines safe from microbial contamination and the need to embrace the latest techniques and technologies in order to make this happen.
