White Papers

White Papers establish or clarify a concept (or framework); they often describe a potential solution or approach to an existing problem or area of discussion. These papers may interpret or clarify a regulatory position, and may seek to influence.

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White Paper

Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production efficiency by making better use of time and resources. This is in addition to addressing the unique challenges faced by pharmaceutical manufacturers such as a strictly regulated environment, heterogeneous equipment suppliers, and long adaptation times....

White Paper

This Concept Paper presents a solution for standardizing one aspect of Plug & Produce, namely the transactional interaction between ISA95 Level 2 (L2) and Level 3 (L3). This solution introduces an OPC UA meta model that allows for the construction and implementation of a service-based transactional interaction. The authors believe that this approach has the potential to reduce project...

White Paper

The ISPE Discussion Paper “Overview of Packaging Validation for Drug Products” explores the different ways to implement packaging validation; however, it does not provide specific guidance on OSD forms packaging. This paper aims to address this gap using concepts based on the 2011 FDA Guidance, Process Validation: General Principles and Practices. Covering Stages 2.2 and 3, this paper...