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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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...
This paper discusses the nuances of lifecycle validation implementation at contract manufacturing organizations (CMOs). Much has already been written on the general implementation of best practices for lifecycle validation, including the elements of quality by design (QbD).
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...
This concept paper provides an overview of these programs, the regulatory environment governing them and best practices for design and implementation.
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.
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.
The need to validate computerized systems used in the context of a clinical trial has increasingly become the focus of regulatory oversight as industry has changed from mainly paper-based processes to electronically supported processes, particularly in the last decade.
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...
The objective of this concept paper is to reflect on a study site survey performed, to draw conclusions from an assessment on comparison of Booklet Labels versus Single Panel Labels performed, to discuss benefits of a Good Practice Guide, and to define the need for training on the proper use of booklet labels. The Good Practice Guide for Booklet Labels will be based on the conclusions and...
