Articles
RSSPQLI Engineering Controls And Automation Strategy
April 30, 2009
•White Paper: PQLI Engineering Controls And Automation Strategy
By Ray Bolton and Stephen Tyler, ISPE
This paper covers the development of engineering controls and automation strategy and how they can be applied in the context of the proposed ISPE PQLI Control StrategyModel as described in PQLI Control Strategy Model and Concepts [6] in this volume of the Journal of Pharmaceutical Innovation and should be read in conjunction with that paper. The Control Strategy Model aims to facilitate communication and understanding of the concept and provide a framework for a structured approach to the development and implementation of a Control Strategy.
The model seeks to link the attributes of the product that are important to the patient, to the controls in the manufacturing process that are needed to deliver those attributes, and also to show in parallel the business requirements. The model shows three levels showing links from the finished product CQAs and other objectives through the manufacturing operations to the controls by which these are achieved.
Click Here To Download:•White Paper: PQLI Engineering Controls And Automation Strategy
