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.
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.
Related Guidance Documents
Commissioning & Qualification (6)
- Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition
- Good Practice Guide: Decommissioning Pharma Equipment & Facilities
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- ISPE Baseline Guide: C&Q (2nd Ed) Download - USD
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Computerized GCP Systems & Data
Critical Utilities (1)
Data Integrity (1)
GAMP® (2)
Quality by Design (1)
Regulatory (1)
Sustainable Facilities, HVAC, & Controlled Environments (1)
Validation (1)
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Webinars Related to Commissioning and Qualification
iSpeak Blog Posts Related to Commissioning and Qualification
Pharmaceutical Engineering Magazine Articles
Communities of Practice Focuses on the Future of Commissioning and Qualification
The Commissioning and Qualification (C&Q) CoP was one of the first Communities of Practices to be…
Remote Acceptance Testing of Automation Projects
Before the COVID-19 pandemic, it was unthinkable for a system integrator to suggest remotely…
Enabling More Efficient and Effective C&Q Through GEP
When the ISPE Baseline Guide Vol. 5, Commissioning & Qualification, 2 ed . was published in 2019…
Accelerating Biopharmaceutical Virtual FATs in a Pandemic
Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has…
Lessons Learned in Global CQV
Global commissioning, qualification, and validation (CQV) project delivery has in recent years been…
ISPE Briefs: Revision to GEP Guide: A Link to QRM-Based C&Q
Since the first edition of the ISPE Good Practice Guide: Good Engineering Practice (GEP) was…
Today’s Pharma and Biotech Projects: A Phased Approach
This article revisits the concept of phased engineering, procurement, and construction (EPC) and…
Master Soil Selection for Cleaning Validation of Parts Washers
One of the goals of the cleaning validation design phase is to define critical process parameters…
Good Engineering Practice in Risk-Based Commissioning & Qualification
Over the years, the roles and responsibilities of engineering and quality/validation personnel for…
Videos Related to Commissioning and Qualification
Training Courses Related To Commissioning and Qualification
Commissioning and Qualification Training Course
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
Facilities Management Training Course
This interactive course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.
Pharma Facilities Project Management Training Course
Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment.
Concept and Discussion Papers
Stage 2 Process Validation: Process Performance Qualification Batches
Authors: Mette Bryder (Lundbeck), Harold Etling (Eli Lilly), Jeff Fleming (Pfizer), Yanhui Hu…
Controlled Temperature Chamber Mapping
1 Introduction This document provides guidance on good practices for the mapping of controlled…
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