Applying ASTM E2500

On October 23rd, ISPE LA held a program about Applying ASTM E2500.

Phil Bowles, Director of Engineering at Amgen Inc., talked about the journey towards a fully mature risk-based approach for commissioning and qualification of equipment and facilities.

Mr. Bowles spoke about the industry’s risk-based approach based on the ASTM E2500 Guide. He explained that ASTM E2500 is a Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. It provides a science (ICH Q8) and risk (ICH Q9) based approach to assure that GMP equipment & systems are fit for use, perform satisfactorily, and may be used in the manufacturing, processing, packaging, and storage of a drug. It applies the concept of critical quality attributes and calls for the use of subject matter experts (SMEs) to make critical determinations, and redefines roles for Quality and Technical SMEs. It allows flexibility so that the company determines the methodology.

He provided an overview of different large biopharmaceutical capital projects, in which the level of implementation differed based on site and project constraints. He found that in order for projects to be successful, people must learn and accept change in order to execute, the process must be agreed-to, compliant, capable of execution and robust, and the organization must be structured to accommodate. He focused on successful projects “E” and “F”, and compared their approaches and results. When risks and mitigation plans are assessed first, and more testing is done during FAT and less on site, then redundancy in testing and documentation is reduced. The impact is that thousands of pages and related work is avoided. Management in projects “E” and “F” saw the value and opportunity in the approach and made the decision to remove constraints at existing facilities. Implementing a risk-based approach to commissioning and qualification based on ASTM E2500 offers significant advantages to manufacturing companies.


Rick Kramer, President of CPFS, spoke about the Project Information Supply Chain’s key role in the path to ASTM E2500 implementation. The term “The Last Planner” suggests that those who do the actual construction usually know best as to how to cost effectively and time efficiently perform the work. ASTM E2500 promotes a similar approach.

Mr. Kramer explained that a SME understands industry best practices and user needs, which means they can meld design to improve user performance. SME goals are to work efficiently to reduce costs. He the pointed out that corporate procurement vendor audits rarely dive down to the project-specific needs, GEP critical needs or overall quality manuals and SOPs.

Qualifying the OEM vendor supply base to participate as SME’s enhances overall GEP and realizes cost benefits and project execution efficiency. A front loaded approach to aligning the Risk Based C&Q strategy with the Project Information Supply Chain allows the intelligent harvest & dissemination of critical Qualification Information, and key Life Cycle Data in support of owner Compliance and OpEx.


Robert Chew, President of Commissioning Agents Inc. and member of the team that wrote ASTM E2500, discussed best practices for implementing an ASTM E2500-based approach to commissioning and qualification.

He began with an overview of ASTM implementation theory and then explained the common approaches and pitfalls. He provided examples of successful projects that have gone well, and more difficult projects that had unforeseen obstacles. Mr. Chew identified the factors that indicate whether or not a project will be good. Firstly, corporate and site leadership support is essential, along with a well-defined program with guidelines, SOPs and templates. A risk-based approach must be adopted from the onset, and the key people and the C&Q partner should be on board early. Another way to ensure a project’s success is to train the entire team at the beginning of the project, as well as additional training when new members are added.

A project may be bad if there is an existing site or a new aseptic fill/ finish facility and if the commissioning lacked good engineering practice. He illustrated this with an example of a bad and ineffective project. In this case, the sites were not aligned with the corporate approach, E2500 was not adopted from the onset, the process was disrupted, vendor quality systems were not adequate for leveraging, and the process and automation design were not fully defined or understood. Mr. Chew concluded with a discussion on some of the tools that have proven to be useful on a variety of projects.

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