pharmaDavos as a week-long convention held annually in February is intended for pharmacists, offering them an attractive platform for professional development and networking in cooperation with numerous trade and industry convention partners. This year the event was held from February 9th to 14th at the Davos Congress Centre.
Alexander Trautmann, pharmacist and Principal Consultant at gempex, along with Magnus Willers of Jobst Willers Engineering AG presented key insights regarding the GMP requirements for producing pharmacies in an expert presentation during the event. Work was also performed on various content jointly with the nearly 40 participants to share user knowledge in the planning and realisation of a producing pharmacy.
The expert presentation in the nature of a workshop focused on the following learning goals:
- Basic knowledge of the GMP regulations that need to be considered in case of changes to structural measures in the pharmaceuticals field
- Relevant basic knowledge for construction projects in pharmaceutical production and food supplement or vitamin preparation production
- Description and comparison of different layout versions for the flow of personnel and materials as well as cleanliness and pressure stage plans
- Sharing planning preparation methods such as gap analysis for construction projects and reviewing the as-built documentation
- Preparation of a performance specification and user requirement specification (URS) to take essential regulations into account
- Methods and tools for the development and description of SOPs (standard operating procedures)
- Interface handling between GMP, engineering, construction management and the commissioning of a producing pharmacy
In addition to sharing the GMP knowledge described above, the presentation was also aimed at a general understanding of GMP. For example, why only qualified personnel with proven GMP knowledge may be employed in a pharmaceutical environment. The insight that GMP regulations are always affected by a wide variety of changes in or to the pharmacy plays just as important a role as the knowledge of which protective measures are required during conversion measures to maintain the pharmacy’s business operations.
With this mix of fundamental GMP information and explicit GMP expert knowledge, the participants not only gained confidence in their future actions but also learned how to avoid the costly and time-consuming rework of neglected measures ahead of time.
Find out further information about GMP in the pharmacy environment.