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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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....
This Concept Paper proves that a standard model within OPC UA Alarms and Conditions (OPC UA Part 9) can be leveraged to realize Plug & Produce for exchanging pharmaceutical alarms and audit trails between OT manufacturing equipment and Orchestration Platforms or IT Services like EBR or Historian.
This Concept Paper proves a laboratory device integration utilizing the Asset Administration Shell (AAS) metamodel (agnostic to the underlying technology and data structure).
The adoption of Environmental Monitoring (EM) through modern technologies, such as BFPCs, has proven to be a long process and requires a solid data set and validation strategy to be accepted by the authorities. This paper provides key points to consider during the implementation of BFPCs as a routine EM tool in modern isolators.
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...
The purpose of this document is to obtain feedback from practitioners on the issues and challenges that may be faced if and when uniquely identified primary containers for parenteral products are implemented within their manufacturing operations.
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...
This Concept Paper is designed to give a better understanding of the challenges and requirements linked to IITs and to offer guidance to pharmaceutical companies/manufacturers providing medication to a sponsor, as well as to noncommercial sponsors sourcing medication independently.
This Discussion Paper discusses considerations for process validation (PV) activities with a specific focus on elements unique to continuous manufacturing processes. The intent is to acknowledge differences or additional considerations for continuous manufacturing processes without creating new definitions.
