Process Control System Basic Guidelines for Process Control System Validation

Author / Editor: Deepak Makhijani / Dominik Stephan

Due to the ever-expanding functionality of modern process control systems, their implementation no longer remains simple. To leverage the benefits of productivity enhancement tools available in the latest process control packages, a clear and complete software functional requirement specification document must be developed before configuring any process control system. Read on to know more…

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The GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacturing provides a detailed systematic approach on automation system validation
The GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacturing provides a detailed systematic approach on automation system validation
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In the real business world, it has often been seen that validation professionals from pharmaceutical companies lack practical experience in relation to the development and use of Programmable Logic Controller (PLC) application software. Understanding and configuring today’s software packages are easier than ever before; however validation of automation systems is indeed an arduous task.

Typically, control system integrators or system suppliers are not trained in current good manufacturing practices (cGMP) or good X practices (GxP) relating to Food and Drug Administration (FDA) compliance where ‘x’ can mean clinical, laboratory, manufacturing, pharmaceutical and others. They also do not possess the solid validation operational experience required for FDA compliance. The know-how gap between supplier and users in the pharmaceutical industry is obvious, and problems caused by this gap can be numerous. As a result, good automation manufacturing practice (GAMP) has come into being to address these issues as it considers the overall automation system validation methodology. Yet, even GAMP serves to provide a guideline only rather than dealing with practical development of the PLC cycle.

Therefore, the emphasis is on good engineering practice (GEP) which ensures that engineering or software development methodology generates deliverables that support the requirement for qualification or validation in the pharmaceutical industry. The control system integrator or system supplier must plan a software development strategy that holds the key to a successful compliant system.

Good Manufacturing Practices (GMP) in Process Plants

Today’s control software packages use a variety of programming languages such as function blocks, ladder logic, sequential function charts, etc. These programs must be clearly documented and easy to update in order to improve the plant’s productivity over its expected life. A simple, universal system of matrix-based documentation can be easily developed jointly by the process control system engineers and production engineers.

Such a methodology of documentation has been created and applied to several batch control plants, the most recent of which are several multi-recipe, multi-product specialty chemical plants. This concept of software documentation, which involves mainly the sequence control and safety interlock logic functions, has proven to be an effective way to transfer process technology and operational know-how of an existing pilot scale operation to a new, fully automated, large-scale production plant.