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

This Discussion Paper examines some of the topics and challenges related to the implementation of current Good Manufacturing Practice (“cGMP”) Process Validation (PV) lifecycle concepts in the management of Quality Systems for existing (“legacy”) commercial products. The paper aims to identify common issues related to the application of lifecycle principles in a legacy product context, and to...

White Paper

This is the second discussion paper written by the ISPE Process Validation (PV) Team on the topic of determining and justifying the number of initial process qualification batches (e.g., FDA Stage 2, EudraLex Annex 15 process validation, EMA Guideline on process validation, etc.) needed to demonstrate a high degree of assurance in the product manufacturing process and control strategy, and...

White Paper

This discussion paper uses segments of typical validation case studies (validation of key attributes such as: content uniformity, packaging key attributes and packaging critical defects) to apply various statistical tools and compare the outcomes of applying each tool pointing out the pros and cons of each application. General comment is also made on the statistical tools applied with some...

White Paper

To address the trial specific setups, eClinical solutions have to be built from various integrated technologies and tools designed to be utilized in clinical trials, working together sharing data, eliminating duplication of activities, and streamlining the use of multiple technologies for the end user.

White Paper

The purpose of this paper is to stimulate further discussion and suggest potential practical application. Approaches to providing an answer are proposed, but more experience in implementation of the lifecycle approach to PV is needed to reach a consensus position.

White Paper

This document provides guidance on good practices for the mapping of controlled temperature chambers, warehouses, and refrigerated storage areas used to store raw material, work in progress, or finished product. It is intended to be used when specifying commissioning and qualification activities. The principles described in this document may be considered for controlled temperature chambers...