GAMP 5 released

GAMP 5 was released in February, 2008. With a focus on Science Based Quality Risk Management and an alignment of thought with ASTM E2500 there has been a change in emphasis, without negating any of GAMP’s previous requirements.  Some general points of note are:

• An increased focus on Risk assessment, continuing a trend that started in GAMP4, recognizing the iterative nature of risk assessment and management and the differing levels at which it can occur. 
• An increased acceptance of using existing documentation to reduce validation effort later in the exercise e.g. use of GOOD commissioning documentation to reduce later OQ effort.
• A move away from the traditional IQ/OQ/PQ terminology to a more inclusive and flexible terminology without reducing any of the need for quality in the products and systems developed or installed.

For those familiar with GAMP4, some specific changes are:

• Software Category 2 for firmware has been removed, Category 1 & 3 revised
• Key supporting processes for projects are identified…
• Additional special interest appendices (e.g. End User Applications such as spreadsheets, Patch Management, Outsourced IS/IT environments).
• New topics in the Management (System Retirement), Operational (e.g. Handover, CAPA) and Development (e.g. Data Migration) appendices
• An Index.

Our CSV training courses are now based on the GAMP 5 approach. Contact our training department to learn how we can assist you – customized courses can be arranged.