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.
- 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)
- 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
Concept & Discussion Papers
Communities of Practice
As an ISPE Member, join an ISPE community of practice to participate in discussions on specific topics with your peers. Learn more about Communities of Practice.