International Society
Pharmaceutical Engineering

The Society for Pharmaceutical Technology Professionals

* About the ISPE 1995 ISPE Educational Programmes

The educational programmes of the ISPE are targeted at professionals working in, or associated with, the pharmaceutical manufacturing industry. The programmes are designed to gives delegates practical solutions to everyday job situations. This uncommon approach has earned ISPE the reputation as one of the leading providers of continuing pharmaceutical education. These programmes fulfill the not-for-profit Society's mission to educate and provide opportunities for the exchange of information for technical professionals in the pharmaceutical manufacturing industry worldwide.

A schedule of pan-European and American seminars has been planned by ISPE for 1995, covering subjects as diverse as Validation, FDA Foreign Inspections (a course that's actually led by the FDA!), Cost-effective Manufacturing, Plant Automation, and cGMP Engineering of Pilot Plants. See below for more details.

* About the GAMP Guide: Validation of Automated Systems

A Supplier Guide on the validation of automated systems in pharmaceutical manufacture is now available from ISPE. Developed by the Pharmaceutical Industry Computer Systems Validation Forum (PICSVF), with assistance from the UK Department of Health's Medicines Control Agency, this Guide has been endorsed by both the Association of the British Pharmaceutical Industry (ABPI) and the Institute of Quality Assurance's Pharmaceutical Quality Group (PQG). It has become known as the GAMP Guide (Good Automated Manufacturing Practice Guide), for short.

Pharmaceutical manufacturers - who are obliged by international regulations to validate computer systems - say that the role played by their system suppliers in validation is of the utmost importance. The Supplier Guide is intended to clarify customers' requirements, so that new computer systems can be more easily and cost-effectively validated. Sample procedures and forms are provided in the Guide, which enable suppliers to implement a suitable quality management system within their organisation to meet the needs of the pharmaceutical manufacturing industry.

The GAMP Supplier Guide was issued as a draft for comment last year. It was susequently revised, based on the feedback received from industry, and is now being published by ISPE in PC-diskette (3.5inch) format to run on standard IBM-compatible personal computers (Model 386 and above, with VGA screen, 4MB RAM, and MS-Windows 3.1).

This PC-diskette version of the Guide has been specially designed for ease of use. It includes `hot' areas on the screen, which open to reveal background information and definitions of terms. Built-in hypertext links allow the user to navigate intuitively around the document quickly and simply. You can choose to purchase a single-user copy, or 10-user version that provides a site-licence.

* About Membership of ISPE

Membership of ISPE is open to anyone with an interest in pharmaceutical technology, and confers a number of benefits such as discounts for attendance at the Society's educational programme events. There are Local Branches of ISPE in many parts of the world, and the Society - founded in 1980 - is growing fast. Why not find out more about ISPE? Or ask your employer to consider Corporate membership.

* For more information ...

For more details about any of the following:

call ISPE Europe in The Hague:

Telephone: +31 70 3645678
Fax: +31 70 3456675

or ISPE's world headquarters in Tampa, Florida, USA:

Tel: +1 813 960 2105
Fax: +1 813 264 2816)

and talk to one of our staff directly.
Copyrightę1994 ISPE


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