On November 20–21, I had the honour of being Chairman at the Sterile Manufacturing Dialogue in Old Windsor, England. Despite a very foggy Sunday night and concern that European speakers and delegates would be delayed (many were forced to land at Gatwick airport rather than Heathrow), a healthy turn out early on Monday morning proved the worries to be unfounded.
After I kick-started the conference with a few choice words, notably the idea that many of those present would be unlikely to let me into their kitchens, let alone their sterile manufacturing facilities, the main event began.
Nick Maishman, senior director of parenterals at Pfizer took to the stage first and delivered a very imaginative presentation on the application of operational excellence (OE) within aseptic fill-finish. Using the analogy of Jonny Wilkinson’s kicking ability on the rugby field, Maishman described various states of process capability and process stability in terms of common or special cause variations. Maishman then went into some detail about Pfizer’s root cause analysis (RCA) strategy, which utilises the six sigma DMAIC approach and lean manufacturing principles, a combination that seems to define OE at Pfizer.
A panel discussion on the “regulatory minefield” followed. I was surprised by the openness of the panel but also of the delegates that contributed. Instead of placing regulatory authorities fully in the firing line, as can often be the case, here there was admission that industry too needs to take responsibility for moving forward with quality to address patient safety issues. I would like to thank all of those who contributed to an interesting and perhaps too short discussion.
Alexander Huber, director of sterile and topical plants at Novartis, and, coincidentally, editorial advisory board member of Pharmaceutical Technology Europe, was second to present and focused on operators, in particular “playing it safe” by using risk and people management successfully. Huber outlined some “pillars to success” an analogy that appeared in a number of presentations. The main concept here was ensuring that everybody in the organisation has some level of responsibility for quality and knowledge of risks, and that training and coaching are key to achieving this state.
Tim Simo, director projects, global technical services at Janssen-Cilag offered excellent insight into outsourcing strategies, in particular the idea of “big pharm to big pharma” in a time of overcapacity in some areas of the industry. What followed was a detailed description of a 12-month assessment process that saw 80 potential partners reduced to three over several distinct selection steps.
Philippe Juvin, quality operations director at Genzyme, managed to captivate and entertain the audience with a double-length talk on a bioburden reduction strategy that saw quality and production personnel working more closely together and get on “the shop floor” to fully-understand operator behaviour and the (sometimes unavoidable) errors made. It was a standout presentation that contained some surprises, such as gowning design changes that produced “wow” level reductions in microbial excursions, and a very frank acknowledgment that the “human” in “human error” is only one part of a chain of events.
And all that was just day one. To get the full story next year, perhaps you’ll have to consider attending yourself… For more information about the Sterile Manufacturing CxO Dialogue and other events, click here.
Be sure to check out our special feature on cleanrooms, which will be available soon in the December issue of Pharmaceutical Technology Europe.