C&Q COP E-Letters

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E-Letters were topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (CoPs). The content for E-Letters was submitted by professionals working in the pharmaceutical industry and was a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems. E-Letters were discontinued in 2013.

*CoPs are an ISPE Member-only benefit; therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing past E-Letter content and other valuable resources that will assist you in being more effective at your job.

July 2011

ISPE Releases New Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
The new Guide provides direction to industry on the implementation of an ICH Q9/ASTM E2500 science- and risk-based approach for demonstrating that pharmaceutical and biopharmaceutical facilities, systems, equipment, and associated automation are fit for intended use and comply with regulatory requirements. The aim of the Guide is to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment. More.

FDA’s Grace McNally Discusses Process Validation Guide with Pharmaceutical Engineering
In an exclusive interview with Pharmaceutical Engineering magazine (July/August issue), FDA’s Grace McNally – a visible player in the development of FDA’s 2011 Final Guidance on Process Validation – shares her experience on the effort it takes to shape such policy and her perspective on the Guide’s key recommendations. More.

ISPE Brussels Conference Seminar 21-22 September Focuses on Science- and Risk-Based Approaches to C&Q
Optimizing operation and maintenance of existing technical systems is a challenge for all involved with design, specification, verification, acceptance, operation, and maintenance of new or existing facilities, systems, and equipment supporting pharmaceutical or biopharmaceutical operations. This two-day seminar, “Commissioning and Qualification: Science- and Risk-Based Approaches – Current Industry Experiences and New Guidances,” includes guidance, real-life case studies, and workshops for strategies you can immediately apply. Hear views from the FDA and subject matter experts from industry. More.

What the C&Q Community is Discussing Right Now
Temperature measurement for small diameter lines, the FDA Process Validation Guide, and change controls for CMOs continue to be hot topics on the C&Q COP Community Discussions page. Use the discussions to share current industry information, best practices, and to ask and answer questions related to the discipline of the COP. (If you are not an ISPE Member, you can read postings, but will not be able to post questions or respond to postings). More.

April 2010

Science- and Risk-Based C&Q: Transitioning and Transforming
The ISPE Washington Conference will feature an intensive C&Q-focused two-day seminar, 7-8 June 2010, Washington, D.C., USA. Outlining risk-based methodologies for planning and implementing a project through the entire lifecycle, this seminar includes case studies and workshops to help you gain a working knowledge of the ISPE Baseline® Guide, Vol. 12: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment. Read more.

ASME BPE Publishes BPE-2009 Standard
Over the last several years, the ISPE C&Q COP has been collaborating with the ASME Bioprocess Equipment Committee in the development of a standard definition for data and document requirements associated with new assets. The initial deliverable produced through this joint effort is the “Vendor Documentation Requirements for New Instruments,” which was published as an appendix in the latest edition of the ASME BPE Standard. This effort will be expanded in the future to include documentation requirements for additional bioprocessing equipment.
The 5th edition of the group’s standard, BPE-2009, was published in the fall of 2009. The October 2009 edition of Mechanical Engineering, The Magazine of ASME, includes a brief history of the journey taken by the ASME Bioprocess Equipment Committee in developing their standards, and a detailed description of the highlights contained in the BPE-2009 edition. The ASME BPE-2009 Standard is available for purchase.

What the C&Q Community is Discussing Right Now
Validation of freezers and incubators, documenting impact and criticality assessments, and autoclave validation continue to be hot topics of discussion on the C&Q COP site. Read more.

January 2010

Applied Risk Management in Commissioning and Qualification
A new Knowledge Brief discusses the sea-change toward science- and risk-based Commissioning and Qualification (C&Q) and how an ISPE Good Practice Guide in development will help firms bridge the gap between traditional C&Q and the risk-based ASTM verification practices. Read more.

Pharmaceutical Engineering Issue Dedicated to Integrated C&Q
The November/December 2009 issue of Pharmaceutical Engineering magazine focuses on integrated Commissioning and Qualification. Topics include science- and risk-based verification, quality risk management principles, pharmaceutical manufacturing and product quality, risk-based qualification, and construction quality management. Read more.

Implementing the ASTM Standard for Verification (C&Q)
Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: “fit for use,” perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. An ISPE recorded Webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle. Read more.

Pfizer Case Study: Implementation of an ASTM E 2500-Based Verification Approach
An ISPE Webinar, recorded at the 2009 ISPE Strasbourg Conference, provides a case study of Pfizer’s Method 4 (M4) project (Define, Measure, Analyze, Recommend and Act) developing a leaner approach to C&Q based on ASTM E 2500.

Lean C&Q: Strategy, Schedule, and Success
Taking the foundation principles of lean thinking and years of streamlined C&Q execution experience, this ISPE recorded Webinar presents a practical approach to lean C&Q. This approach is broadly based on ASTM E 2500-07 principles and key perspectives from ICH Q8R, Q9, and Q10. It focuses on what is important up front at project kick-off for a better chance of getting it right the first time. Read more.

Baseline Guide 12 Overview
This ISPE recorded Webinar provides an overview and introduction to the completed draft of the new ISPE Baseline® Guide 12: Science and Risk Based Approach for the Delivery of Facilities, Systems, and Equipment. The Guide provides the “how to” for implementation of the verification approach described in the ASTM E 2500-07 Standard. Read more.

What the C&Q Community is Discussing Right Now
Pure steam generator and autoclave qualification, load cell display calibration, SIP – steam quality, supplier qualification for a new facility, and validation of freezers and incubators continue to be hot topics of discussion on the C&Q COP site. Read more.