Remote I/O in the Pharmaceutical Industry Using GAMP4

PROFIBUS has emerged as a leading bus technology in process instrumentation. Its fast data rates and excellent accuracy have led to new installations and plant retrofits being predominantly fitted with PROFIBUS Remote I/O. It also lends itself to GAMP (Good Automated Manufacturing Practice) procedures.

Instrumentation practices in the pharmaceutical industry usually include GAMP procedures. The principles are based on internationally accepted guidelines published by the ISPE (International Society of Pharmaceutical Engineering). Validation is a mandatory requirement. National controlling authorities such as the FDA (Food and Drug Administration) ensure that it is being carried out to the appropriate level. Validation may be defined as establishing documentary evidence that a specific process will consistently produce a product that meets its predetermined specifications and quality attributes (FDA Guidelines – May 1987.)

The Validation Plan (VP) defines, organizational guidelines, life cycle plans, basic procedures of the validation process, tasks and responsibilities of the parties involved, scope of supply and acceptance criteria.

It ensures the following:

• The project is planned.
• The functional requirements are thought through and agreed by both parties.
• The degree of testing is ascertained and agreed by both parties.
• Ambiguities and misinterpretations of requirements and tests are removed.
• The product does what was agreed and proven to do so with a sufficient level of documentary evidence.

PROFIBUS Remote I/O offers a very cost effective way to handle a large amount of input and output data on a single bus line.

The GAMP4 FATs have ensured that by the time of its arrival on site, the Remote I/O has already been configured and tested. Valuable commissioning time is saved and the RIO system is fully validated with the necessary documentary evidence to prove it.

A specialist article, which appeared in the December 2007 issue of the P&A Magazine – the dedicated journal for process technology and automation – provides a substantial insight into automation and instrumentation practice in the pharmaceutical industry. It shows how modern, fieldbus-based instrumentation, can be used in order to obtain the requisite validation, whilst helping the user to save costs. The principle is based on internationally recognized guidelines and the components discussed are fully in compliance with ATEX. The corresponding regulations are set out in the EU directives and standards, such as 94/9/EG [1] and 99/92/EG [2]. Further information on the validation methods is contained in the GAMP4 handbook, which is published by the ISPE [3].

You are welcome to download the contribution from our web page, or ask us to send you a free copy!