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.
PE Articles
Volunteer Profile: Combination Products Community of Practice Chair - James P. Wabby, MHMS
For more than 22 years, James P. Wabby has dedicated his career to quality operations, regulatory…
Video
Medical Device Sterilization with FDA
Medical Device Sterilization with FDA Complimentary Learning Level: Intermediate/Advanced Session…
PE Articles
Communities of Practice Profiles: Shaping the Future of the Combination Products Industry
Combination Products is one of ISPE’s newest Communities of Practice (CoPs). It started as a Special…
iSpeak Blog
China’s Regulatory Framework for Combination Products: Ongoing Challenges and Potential Opportunities
As the world’s second largest market for pharmaceuticals and accounting for 20% of global medical…
Video
Regulatory Responses to 503B Compounding Pharmacies
Complimentary Learning Level: Intermediate Session Length: 1 hour Most 503B compounding facilities…
iSpeak Blog
What is the Impact of Article 117 on the Pharma Industry?
Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly…
Guidance Documents
Commissioning & Qualification (6)
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- 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
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
Critical Utilities (1)
Data Integrity (1)
Quality by Design (1)
Regulatory (2)
Sustainable Facilities, HVAC, & Controlled Environments (2)
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Dec 11, 2024
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Dec 04, 2024
Good Manufacturing Practice
Dec 04, 2024
GAMP®
Lifecycle Management
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
Embracing the Unknown: QRM Strategies for Cell and Gene Therapies Facilities
The pharmaceutical landscape is rapidly evolving, and cell and gene therapies (C>) are at the…
Experts Create Examples of C&Q Deliverables
In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and…
Key Findings from the 2023 C&Q Baseline® Guide Survey
The ISPE Baseline ® Guide Volume 5: Commissioning and Qualification (Second Edition) framework has…
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
Professional Development Training
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.
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