Prepare the pharmacy for the future

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The new Pharmacy Operating Regulations (§35 ApBetrO) present pharmacies with new challenges. According to the guidelines of the Federal Ministry of Health, pharmacies should in the future adhere to GMP (Good Manufacturing Practice) rules. The production of cytostatics and other sterile medicines, as well as re-blistering, will therefore take place in cleanrooms in the future. According to the Regional Administrative Authority, there is a transitional period of two years for pharmacies. After that, every pharmacy involved in sterile manufacturing must comply with the new regulations. What are the consequences for pharmacies, and how should the requirements be implemented properly and efficiently? Experts from authorities, pharmacies, and industry will provide answers through lectures and workshops at the 14th basan Cleanroom Forum in Kelsterbach.

The new Pharmacy Operating Regulations have been received largely positively in practice. The expanded regulations for the production of cytostatics and other parenteral medicines serve to ensure quality in one of the pharmacy's core areas. They are a further step towards even higher medication therapy safety for patients. At the same time, they do not overburden pharmacists; the new regulations are feasible to implement.

Provided one knows how! Pharmacies producing cytostatics must quickly address questions regarding compliant spatial and technical equipment of cleanrooms. Decisions about disposable or reusable clothing, consumables, cleaning and disinfectant agents must be made, processes for validated contamination control must be implemented, and structured workflows in a sterile production environment must be trained with staff — all economically and within deadlines.

The 14th basan Cleanroom Forum provides pharmacies with support here: with expert knowledge, practical training, and implementation strategies for cost-optimized and qualified execution.

The key data of the 14th basan Cleanroom Forum:
Target audience: The event is aimed at pharmacists and technical staff who want to meet the requirements of the current regulations — competently, efficiently, and economically.

The topics: In four expert lectures by representatives from authorities, pharmacy practice, and application-oriented industry, the foundation of the new regulations will be conveyed, as well as practical and efficient implementation strategies provided to participants. Two workshops will focus on two important topics regarding behavior in the pharmacy's cleanroom: the correct dressing procedure and GMP-compliant cleaning.