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 sure that a facility —and the equipment in it— will function as required and be approved by the regulatory agencies that have jurisdiction over that facility.1
Produced by pharmaceutical manufacturing industry professionals, ISPE offers a variety of resources to help narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions.
Commissioning and Qualification Training Options
Learn from and connect with subject matter experts and peers in your field. Gain 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.
On Demand
- Demystifying Your Questions on Revised Commissioning & Qualification ISPE Baseline Guide Vol. 5
- Facilities and Equipment: Commissioning and Qualifications as a Risk Management Strategy
- FDA Process Validation Guidance: A Review with Implications for Commissioning & Qualification
- Implementing ASTM Standard for Verification Commissioning and Qualification
- Polishing an Old Gem: Commissioning & Qualification Baseline Guide Update Webinar
- Science and Risk Based Commissioning and Qualification Approach (Recorded)
Online Live
- Commissioning & Qualification Pharma Training Course
- Commissioning and Qualification Training Course
- Facilities Management Training Course
ISPE Baseline® Guide: Commissioning and Qualification (Second Edition)
This revision of the Guide simplifies and improves the Commissioning and Qualification process by bringing the “best of the best” together into one document—combining concepts from global regulatory agencies, such as EMA, FDA, and ISO.
Pharmaceutical Engineering® Magazine Articles
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iSpeak BlogThis 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 BlogThis 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...
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iSpeak BlogThis blog is the second 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...
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iSpeak BlogThis blog is the first 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...
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TechnicalOver the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification (C&Q) activities have evolved. Now more than ever, commissioning and qualification approaches based on quality risk management (QRM) principles rely heavily on...
Concept & Discussion Papers
Communities of Practice
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