Replacement Batch Control System for a Multipurpose Contract Manufacturing Plant

WBF - 2000

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Successful Contract Pharmaceutical Manufacturing in a GMP regulated environment is heavily dependent on the flexibility and utilisation of the available processing plant and its guaranteed performance. However, changing plant configuration and revalidation is time consuming and therefore costly.

This paper presents a case study of the implementation of an S88.01 based control system, as part of a strategy to change an existing process building with single product manufacturing capability, to a multi-purpose plant and contrasts it with an earlier retrofit implementation to a similar plant for multi-product use.

The paper reviews some important considerations in the equipment model design including the design approach for the control system architecture and methodologies employed for software coding of generic phases, which have been found to yield real economic benefits and ensure the achievement of the required plant flexibility. It also reviews the benefits to the design and validation process from following a structured 'GAMP3' approach.

Some of the measurable economic benefits achieved will be shown to include reduced project implementation time, life cycle cost savings through reduced manpower effort during the engineering and validation stages and production capacity increase.

Electronic Batch Records and Flexible Batch Reporting

WBF - 2002

S88.01 defines batch history as ' a collection of data relating to one batch'. This is expanded by S88.02 to show that a batch history is an aggregation of both common and batch specific elements. A batch history may be made up of data collected by several systems and held in multiple locations. From this collection of data it may be required to produce for different purposes several batch reports.

This paper reviews with the aid of case studies some methods of implementing flexible batch historian and batch reporting systems and discusses some of the issues faced such as 21CFR part 11 compliance and the integration of time series data and batch event data.