A special issue dedicated to the GERPAC 2016 meeting

This special issue is dedicated to the last GERPAC European meeting which took place in Giens, France in October 2016. GERPAC (http://www.gerpac.eu) is the European group for drug production in controlled areas. The purpose of the GERPAC association has been from the beginning to promote the techniques and skills needed for the development of biological and physico-chemical protection in the hospital pharmaceutical environment where hazardous drugs are being prepared. In the last five years, this purpose has further evolved to promote all works related to pharmaceutical technology in hospital pharmacy including sterile and non-sterile production. This is why GERPAC naturally accepted to foster our journal dedicated to pharmaceutical technology in hospitals.

In this special issue you will find two short papers summarizing two of the four workshops of the last meeting. In the first one named “Quality Management Workshop: Feedback on ISO Certification in a Pharmacotechny Unit”, the experience of ISO certification is discussed between the authors (S. Perriat, JM. Canonge, Y. Cretu and F. Puisset) who managed to obtain certification in their unit in Toulouse, France and the public for whom this approach is still not well known and very complex. The Unit is very important as it produces more than 100,000 injectable drugs per year. Thus, in this particular case, the certification is a good strategy to certify the quality of the products in a quality insurance process. The second workshop reported by ML. Brandely-Piat and L. Bouchoud was a discussion about challenges and opportunities of subcontracting. The authors took into account the French and Swiss regulations but the workshop arguments are interesting for a wide range of countries where subcontracting in pharmacy compounding is allowed. The paper highlights the importance of quality indicators and the conditions for auditing the subcontractors. Those are keys to assess the quality of the products.

After those workshop reports, you will find in this issue three original short research papers. The first one from C. Balouzet is a stability study of azacitidine suspensions after freezing directly in the syringes. This study demonstrated the stability of azacitidine (condition 1 month at -20 °C then 3 days at 5 °C), thus allowing the in advance preparation of those ready-to-use syringes. This is important in order to organize the production program as much as possible. In fact, dose banding of azacitidine syringes can thus be envisioned. The second research paper from C. Gerard was aimed at the determination of hydrogen peroxide diffusion in IV bags by spectrophotometry thanks to a colorimetric reaction. The results showed that, under their study conditions (isolator type and cycle), overwrapping was not mandatory to protect infusion bags from H₂O₂ diffusion. This finding allowed the authors to remove overwrapping in order to simplify the production process to implement a lean production process. The third original paper from F. Feutry describes the combination of the use of a pneumatic system with automated storage areas to solve the issue of traceability. This system makes the delivery to the wards much more efficient and secure. It also prevents waste of time. From all three papers above it becomes obvious that pharmacists working in chemotherapy units are running against time and perform a wide range of studies to maintain the quality of the prepared products in a time that gets shorter year after year. This race against time may be dangerous but as long as the quality of the products is assessed, a lean procedure is what should be aimed for.

In this issue you will also find an opinion paper on the quality controls implemented in chemotherapy units. This subject is under large debate, no universal answer can be given as the expertise, scale or type of products varies from one center to another. The opinion presented here belongs to its author (F. Lagarce) and is an attempt to list the pros and cons of every control technique. The key messages here are that no technical solution is a pure winner and each pharmacist has to choose what control he wants to implement in the compounding process. At the end he will be the one to justify his choices. Quality control of the final product or within the process is mandatory but each center may be considered as a particular case. This opinion paper would like to be a help for the reader to look at the key points and make up his mind on what he wants to use, to secure the chemotherapy production process. Costs, expertise, chemical contamination, workload are examples of what to look at.

Finally this special issue ends with the abstracts of three awarded communications of the last GERPAC showing once again how diverse the works in our domain are. We really hope that reading these abstracts will make you want to come next year to participate but also to submit papers in the next month for meeting presentation but also for publication in our journal.