Commissioning and Qualification

News & Press Releases
01 July 2019
ISPE announced the release of their latest guide, ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) . This Guide provides practical guidance on the implementation of a science and risk-based approach for the commissioning and...
Guidance Docs
The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.
Technical
As the global population demands faster and more affordable drugs, biopharmaceutical companies are continually trying to find ways to produce their drug products more economically and efficiently. Today, the competition and need for drugs are greater than ever before. Companies have been...
Concept Papers
1 Introduction This document provides guidance on good practices for the mapping of controlled temperature chambers, warehouses, and refrigerated...
Guidance Docs
Published: July 2014 Pages: 120 Table of Contents Special Pricing for Emerging Economies Water and steam may be used in the manufacture of products, cleaning operations, and laboratory activities within pharmaceutical or biopharmaceutical operations.
Basic page
This online course provides an overview of success factors for Commissioning and Qualification projects . It examines key planning steps at the program level and important system level activities that occur prior to...
Training
Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and....
Training
This interactive classroom course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program,....
Training
This classroom course is designed to improve the way in which the industry delivers regulated manufacturing capacity: improving the ability to meet....