Working Groups - Overview
In ISPE D/A/CH, members are actively involved in regional working groups and the CoP’s (Communities of Practice). Through technical/topic-based workshops, discussions, and communication, best practice working papers and approaches are developed in the sensitive environment of patient safety. They serve as guidelines for the industry and the authorities. Members of ISPE D/A/CH participate in the ISPE Guides.
Many ISPE documents and guides are freely available to members:
The global ISPE network promotes the international exchange of experience by directly and personally addressing regionally and internationally organized members in ISPE. Members have free access to the ISPE member directory for contact search and establishment.
Participate, address the contact points indicated in the working groups directly by mail.
CoP = Regional community (group) of practice
SIG = Special Interest Group
Working Group 1:
Aseptic Processing (CoP)
The goal of the CoP “Aseptic Processing” is to provide operators, planners, manufacturers and interested parties involved in the technology of aseptic production in their daily work with a discussion platform for specialist topics and for the exchange of experiences. This objective is supported by annual technical discussions on topics in the field of “Aseptic Processing”. It is a particular goal to include dialogue with representatives of the authorities in the technical discussions. In addition, there is a regular exchange with the CoP’s of other affiliates.
Working Group 2:
The aim of the CoP “Containment”: to offer operators, planners, manufacturers as well as interested parties who deal with containment systems in their daily work a discussion platform for technical topics and for the exchange of experiences. This objective is supported by annual expert discussions on topics in the field of “containment”, and there is also a regular exchange of experiences with the CoP’s of other Affiliates. The current focus of the group’s work was the creation of a containment manual.
Working Group 3:
Good Automation Manufacturing Practice GAMP (CoP)
The aim and purpose of GAMP D-A-CH is to strengthen the acceptance, awareness and application of the current GAMP Guide in the life science industry, suppliers and authorities in the German-speaking countries of Germany (D), Austria (A) and Switzerland (CH), to create a neutral platform for the exchange of information and to contribute to further developments and the success of the GAMP Guide.
Working Group 4:
HVAC & Sustainable Facilities (CoP)
Our goal: to offer operators, planners, manufacturers and interested parties who are involved in “Facility Design and HVAC” in their daily work a discussion platform for specialist topics and for the exchange of experiences. This objective is supported by annual technical discussions on topics in the field of “HVAC & Sustainable Facilities”. In addition, there is a regular exchange with the CoP’s of other affiliates.
If you are interested in helping out, please get in touch.
Working Group 5:
Pharma 4.0 (SIG)
The initiative of the authorities (in cooperation with industry and ISPE) has given rise to ICH documents Q 8 to 12. They describe the flexible and knowledge-based Quality by Design approach. The “Control Strategy” plays a very decisive role in this. It was created both for drug approval for the first time for the pharmaceutical product with a focus on CQA/CPP/CMA, but also later expanded for technology transfer and for commercial production to include the corresponding GMP-oriented CQA/CPP/CMA.
In practical implementation for commercial production, the “automation strategy” not mentioned in the ICH still needs to be developed in the companies as a “control strategy”. This is an opportunity to develop and present best practices.
But how is all this put into practice? What are the requirements for implementing Pharma 4.0? What practical examples already exist and who can I talk to about them? We want to take up this complex of topics, work on it and answer the questions in the ISPE network.
Working group 6:
Future Robotics (SIG)
The combination of artificial intelligence in the form of robots, combined with human experience and knowledge, will shape the pharmaceutical industry in the coming years.
What options are there for automating manufacturing processes and controlling process sequences reliably and reproducibly?
What will pharmaceutical production and laboratory activities look like in a few years?
– Industrial Robotics
– Future Robotics
The goal is to create a handbook ‘Robotics in Pharma’.
Working group 7:
Project management (CoP)
Engineers work with, in and on projects. The project management of these sometimes very complex projects is of great importance, as the project team is responsible to its client for the deadlines, costs (effort) and results. Together with external suppliers and service providers, the result is a complex structure.
In our workshops, we learn by sharing our experiences.
The group meets with interested parties at least once a year, usually at the beginning of the year, and deals with a main topic.
We also think outside the box and discuss with experts from other industries (automotive, shipbuilding, aviation, food). Join in.
Working group 8:
Water & Steam (CoP)
The aim of the CoP “Water & Steam” is to provide a platform for experts from the pharmaceutical industry to discuss specialist topics and exchange experiences. In addition, this group will actively participate in future revisions of the Baseline Guide Vol. 4 “Water & Steam” participate. These objectives are to be pursued through annual technical discussions on topics from the field of “Water & Steam”, the content of which is determined in each case by the participants. By communicating with CoP’s of other affiliates, experiences can be shared on a regular basis.
current and future-oriented topics
Several workshops throughout the year address current and future-oriented topics, with a high practical content (company visits, best case presentations, discussions and lectures) and high benefit for the participants.
Our workshops are also open to non-members. Join in!