Commissioning and Qualification

Technical
Global commissioning, qualification, and validation (CQV) project delivery has in recent years been required to push the boundaries on delivery methodologies and techniques to ensure sufficient production capacity is available to meet ever-expanding patient needs. This article focuses on lessons...
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
Features
Across every industry today, digitalization is driving the use and value of data to disrupt traditional business models and ways of working. In pharmaceuticals, the promises of Industry 4.0 are expected, and needed, to finally modernize the legacy approaches that have evolved since the 1970s....
Video
Why is commissioning & qualification important? Is qualification the same as verification? What is a key factor when implementing a risk management approach to commissioning and qualification? What is a common...
None
Commissioning and Qualification (C&Q) are terms and processes related to the manufacturing of pharmaceutical or biotechnology products. Each term represents a scope of work that is part of a larger framework for making...
Video
Learning Level: Intermediate - This webinar session is a follow-up to last summer’s popular webinar, “Polishing an Old Gem: Commissioning & Qualification Baseline Guide Update” which gave participants an overview of the...
iSpeak Blog
This blog is the last of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...
iSpeak Blog
This blog is the third of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...