Welcome to the GAMP Benelux site
On April 17th 2008 a number of representatives of companies in the pharmaceutical branch founded an ISPE GAMP Community Of Practice for the Dutch market. This meeting took place at the initiative of René van Opstal at the Koning & Hartman premises in Delft. On June 19th the steering committee decided, together with members of the Belgium CSV COP to enlarge the scope of the GAMP COP to the Benelux (Belgium, the Netherlands and Luxemburg).
The COP is linked to the ISPE GAMP forum and the Dutch and Belgium ISPE affiliates. The ISPE GAMP COP Benelux focuses on collecting and providing information and knowledge in the area of GAMP. For this purpose workshops and seminars will be organized supervised by the COP steering committee.
Details about this COP are defined in our Charter.
GAMP® is celebrating 25 years of innovative good practice in 2016!
Starting from an industry initiative in 1991 in response to FDA inspections, today GAMP® is still the leading industry guidance on computer systems compliance, available in several languages.
The GAMP community is an international community, with local groups all around the world (America, UK, Europe, Asia, Japan, ...) promoting the innovative use of automation and computer technology in a risk-based approach for Life Science Industry.
There are a number of emerging hot topics that GAMP has engaged in through sponsorship of Special Interest Groups (SIG) about Cloud, Data Integrity, …. and through publishing GAMP Good Practice Guidances.
As initially the focus was Good Manufacturing Processes (GMP), GAMP is also willingness to tackle technology evolutions in the Life Science Industry related to R&D, Clinical, Medical Devices, etc.
We invite you to celebrate GAMP’s 25th Anniversary at ISPE GAMP Europe Regional Conference, Copenhagen, Denmark on 4th October, or looking forward to see you at one of our next local GAMP COP Benelux events!
ISPE GAMP® COP released a Concept Paper entitled “Considerations for a Corporate Data Integrity Program”
Regulatory agencies, as well as industry, rely on accurate information to ensure drug quality and patient safety. If the information associated with a drug product is not accurate, complete, or reliable, a company cannot ensure the safety and efficacy of their product for the patient. Data Integrity therefore has become one of the hottest regulatory and compliance topics impacting the pharmaceutical industry in years.
To help understand the critical success factors for a corporate data integrity program, the ISPE GAMP® COP released a Concept Paper entitled “Considerations for a Corporate Data Integrity Program”. The paper addresses the topics of executive sponsorship, cross functional ownership, risk-based prioritization, planning for continuous improvement, and focusing on the data integrity lifecycle. It also provides some practical insights into ensuring the sustainability of the program and the data integrity lifecycle.
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