Commissioning and Qualification

Article
Technical
Lessons Learned in Global CQV
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 captured in the execution and resource management of large-scale global CQV projects in an...
Guidance Documents
Guidance Docs

Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition

Good Practice Guides
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
The History & Future of Validation
Features
The History & Future of Validation
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. Validation is an obvious target for digital disruption because of the inefficient, document-heavy...
Video

Commissioning and Qualification FAQs

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...
Commissioning and Qualification Resources Banner
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Commissioning & Qualification Resources

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

Demystifying Your Questions on Revised Commissioning & Qualification ISPE Baseline Guide Vol. 5 Webinar

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...