CoP GAMP D-A-CH
About
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.
Aim and purpose
GAMP D-A-CH is a neutral platform for the exchange of information in the life science industry, suppliers and authorities in the German-speaking countries of Germany (D), Austria (A) and Switzerland (CH).
The goal is to strengthen the acceptance, awareness and application of the current GAMP Guide and to contribute to further developments and the success of the GAMP Guide.
GAMP D-A-CH activities (forums, working groups, conferences)
GAMP D-A-CH organizes two one-day forums per year for the exchange of experiences and for the presentation of current new topics in the field of computer system validation. The meeting location changes, the member companies (sponsors) provide premises.
In special working groups (so-called Special Interest Groups – SIGs), which meet more often per year, topics are developed which are published in GAMP publications, VDI/VDE guidelines and journal articles.
In cooperation with 4 organizations (ISPE D/A/CH, VDI/VDE-GMA, APV and Concept Heidelberg), GAMP D-A-CH organizes an annual conference on computer system validation, usually in early December.
Active SIGs or working groups
– Supplier auditing
– Application of GAMP principles to the manufacture of medical devices and products.
– Audit Trail Review
– Data protection/IT security in the GxP environment
– Blockchain in the GxP environment
– AI in the GxP environment
Organization
GAMP D-A-CH is a local CoP (Community of Practice) of ISPE D/A/CH and a technical committee of the VDI/VDE-Gesellschaft Mess- und Automatisierungstechnik (GMA).
It will be led by a steering committee of ten members, at least four of whom should be from life science companies, one from government agencies, and the rest from supplier companies, consultancies, or universities.
The Steering Committee is led by a Head and a Deputy Head, who ensure the integration into the international GAMP organization (GAMP-CoP of ISPE) and cooperate with the offices of ISPE-D/A/CH and VDI/VDE-GMA.
The secretarial tasks are covered by the VDI/VDE-GMA.
Membership in GAMP D-A-CH
Those interested in participating in GAMP D-A-CH should come from the technical environment of IT/Automation/Life Science.
To become a member, please register on the page www.vdi.de, or directly in the registration form, or send an email to the head or deputy head of GAMP D-A-CH. Please provide your full name, company name and address, including phone number and email address.
Please indicate whether your company is a life sciences company, a systems manufacturer, a consulting company, a government agency, or a university.
After your registration you will receive the corresponding invitation about four weeks before the next meeting.
Access to the forum pages for members
GAMP D-A-CH operates a protected area for GAMP D-A-CH members with a lot of detailed information and download options, including the presentations from the forums.
The link to the members page is at the top right. For access you need a password.
Dates of the forums
The forums are held at six-month intervals on a Wednesday in the first half of March and the first half of September.
More details can be found on the forum pages for members (see above).
GAMP and GAMP-D-A-CH publications
– GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (also in German)
– A Risk-Based Approach to Operation of GxP Computerized Systems (also in German)
– Records and Data Integrity (also in German)
– A Risk-Based Approach to Testing of GxP Systems (Second Edition) (also in German)
– A Risk-Based Approach to Calibration Management (Second Edition)
– A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
– A Risk-Based Approach to GxP Process Control Systems (Second Edition)
– A Risk-Based Approach to Regulated Mobile Applications
– Global Information Systems Control and Compliance (Second Edition)
– IT Infrastructure Control and Compliance (Second Edition)
– Manufacturing Execution Systems – A Strategic and Program Management Approach
– Validation and Compliance of Computerized GCP Systems & Data [Good eClinical Practice]
– Data Integrity – Key Concepts
– Data Integrity – Manufacturing Records
– Data Integrity – Data Integrity by Design
VDI/VDE guidelines (in German and English)
– VDI/VDE 3516, Validation in the GxP environment
– Sheet 1: Open Source Software (09/2013)
– Sheet 2: Small production and test equipment (11/2013)
– Sheet 3: Alternative software development models and methods (07/2016)
– Sheet 4: Automated testing (04/2016)
– Sheet 5: Types of raw data (03/2019)
– Sheet 6: Validation of interfaces (01/2020)
Manager
Oliver Hermann
QFINITY Quality Management
Stellvert. Manager
Frank Behnisch
CSL Behring GmbH
Stellvert. Manager
Prof. Hartmut Hensel
i.R. (formerly Harz University of Applied Sciences)