We frequently travel to our clients in other parts of the world but never before in our history we had to visit Indian companies three times a quarter. One of these trips was about auditing two manufacturing facilities of a client which are bound to launch their products on the European market. Both a solid dosage form facility as well as a parenteral facility were involved. The other two visits regarded manufacturing facilities supplying anti-tuberculosis medicinal products which find their way from India to WHO-sponsored support programs in Africa. Understandably, the WHO requires such facilities to operate according to the WHO-GMP regulations and our job was aimed at improving their compliance with these requirements.
Incidently we get involved in hospital care projects and such a project indeed passed by during this summer. We had to perform a quality audit of a private healthcare clinic but were asked to use a manufacturing operations quality checklist which, of course, mainly showed non-applicable items. So, we had to merge this checklist with another checklist specifically designed for healthcare clinics which we gratefully borrowed from the ZKN-organization. This organization (Zelfstandige Klinieken Nederland = Independent Clinics The Netherlands) promotes the establishment and growth of such clinics, including the development of quality programs.
Impurities, originating from badly designed or failing manufacturing processes, were another kind of atypical projects during this period. Once of these cases included printed labels ending up in dissolutions tanks, leading to trace amounts of ink and glue in the solutions. No matter how “tracey” these amounts may be, somebody has to calculate the toxicological risks associated with it. The other project was not about the toxicological impact of the impurities but merely needed corrective actions in the manufacturing area to prevent recurrence of particulate contamination in another parenteral product. However, the significant investment costs associated with such corrections, led to intense discussions about at what particular places a Grade A environment would be needed and what then would be the impact on the level of particulate contamination in this medicinal product. Throughout the course of this project a 1978 Queen song kept haunting my mind in paraphrase: particle, particle particle……..