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Equipment Qualification, Facility
Qualification,
Utility Qualification
Overview of ASTM Standard E2500-07
In May 2007, ASTM Standard E2500-07, titled “Standard Guide for
Specification, Design, and Verification of Pharmaceutical and
Biopharmaceutical Manufacturing Systems and Equipment,” was issued.
This standard describes a risk-based and science-based approach to the
specification, design, and verification of new and existing
pharmaceutical and biopharmaceutical manufacturing systems (i.e.,
systems including: facility equipment, process equipment, supporting
utilities, associated process monitoring and control systems, and
automation systems).
ASTM Standard E2500-07, which is a consensus standard, and the ISPE
guidelines provide a well-defined structure and framework for building
an engineering-centric quality management system for managing and
implementing business-critical commissioning, qualification, and
validation projects associated with facility, equipment, and utility
systems (including the control systems).
The standard describes an approach for simplifying the current
commissioning, qualification, and validation activities to a more
streamlined and practical value-added set of verification and
performance testing activities. The verification responsibility and
activities will be engineering-centric and the performance testing
will be the responsibility of the site’s operations and quality
management organizations. Quality Assurance’s involvement will be less
formal for verification activities with ‘Engineering Quality
Assurance’ managing and assuring compliance to the engineering quality
management system and process.
This new approach will significantly shift the current qualification
responsibilities and activities associated with facility
qualification, equipment qualification, and utility qualification to
the company’s corporate engineering group (i.e., corporate engineering
management, project engineers, etc.) and support organizations for
major projects, such as, engineering and design firms, equipment
vendors, construction contractors, engineering contractors, and
architects
The ISPE guidelines provide the pharmaceutical industry and FDA
accepted best practices for supporting facility, utility, and process
equipment and control systems commissioning and qualification
activities for a variety of pharmaceutical products (i.e., aseptic
solutions, biopharmaceuticals, API, solid dosage forms, etc.) and
technologies (i.e., CIP, SIP, WFI systems, sterilization systems,
filtration systems, etc.). ISPE’s commissioning and qualification
guideline and GAMP guideline are both currently being revised to
harmonize with the ASTM E2500-07 standard and to also provide more
prescriptive guidance on how to meet the intent of the standard and
current FDA expectations for commissioning, qualification, and
validation.
This more practical approach to facility qualification, equipment
qualification, and utility qualification will more cost-effectively
and efficiently ensure that manufacturing systems and equipment are
fit for intended use, and that risk to product quality, and
consequently to patient safety, are effectively managed.
Using the approach described within the ASTM Standard E2500-07 will
satisfy international regulatory expectations of
regulated-manufacturers to satisfy requirements for design,
installation, operation, and performance of controlled processes to
assure that they can consistently produce product meeting defined
quality requirements.
Compliance Team Capabilities
Compliance Team has a wealth of experience of planning, managing, and
executing commissioning and qualification projects for clients in the
pharmaceutical, biopharmaceutical, and medical device industries. As
regulations, standards and guidance have evolved; we keep our teams
current and adjust our approach to keep our clients compliant. Our
teams deliver the highest quality commissioning, qualification, and
validation documents for facility systems (including HVAC equipment),
equipment systems, and utility systems, including the control system
validation documents. Our support helps ensure the safe and efficient
start-up of new facilities and changes to existing facilities required
for expansion of existing production capacity.
Our teams support each client’s engineering and quality organizations
by developing validation documents, such as, validation plans, user
requirement specifications, functional requirement specifications,
design qualification, commissioning test plans, system impact
assessments, component impact assessments, factory acceptance tests,
installation qualification, operational qualification, performance
qualification, process validation, etc., as needed for compliance with
today’s engineering best practices.
We have a diverse base of experience in developing facility
qualification, equipment qualification, and utility qualification
protocols for our client’s projects associated with many different
types of products (medical devices, pharmaceutical, and
biopharmaceutical) and including all of today’s technologies and
process and utility system equipment and controls. The documents
prepared include:
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Commissioning Plans
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Validation Plans
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HVAC Qualification Protocols
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Environmental Monitoring Performance Qualification Protocols
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Facility Qualification Protocols (i.e., API, Aseptic, Sterile, OSD,
Warehouse, Cleanrooms, Radio-Pharmaceutical, Biopharmaceutical, etc.)
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Utility Qualification Protocols (WFI, RO/DI/Purified Water, Pure/Clean
Steam, Clean Compressed Air, Nitrogen, etc.)
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Equipment Qualification Protocols (Aseptic Systems, OSD,
Sterilizers, Fillers, Lyophilizers, Bioreactors, Autoclaves, Packaging
Lines, CIP, SIP, etc.)
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Compliance Team differentiates the quality and value of our services
by staying current with today’s best practices and international
regulatory expectations for commissioning, qualification, and
validation. Our involvement in the ISPE community provides us with
great perspective and insight into strategies for implementing
practical and compliant solutions pertaining to commissioning and
facility qualification, equipment qualification, and utility
qualification consistent with the evolving harmonized regulatory
framework around risk-based and science-based approaches to regulatory
compliance.
Compliance Team provides practical solutions based on ASTM E2500-07
that improves the engineering process and delivers a more
cost-controlled, efficient project in compliance with current
regulatory requirements and expectations. Our solutions apply the
concepts and principles introduced in the FDA’s document titled
'Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach', and
in the ICH Q8, ICH Q9, and ICH Q10 documents.
We are ready to share our teams’ experience in delivering
cost-effective and practical solutions to your organization. We will
support your commissioning and qualification requirements and the
on-time delivery of your critical projects to help meet your business
objectives.
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