Equipment Verification New approach now approved:
ASTM Standard E2500-07 Standard Guide for Specification,
Design, and Verification of Pharmaceutical and Biopharmaceutical
Manufacturing Systems and Equipment
1. What is ASTM; What influence has it on the GMP-regulated pharmaceutical
industry?
ASTM is the American Society for Testing and Materials. It is a long-established
consensus standard setting body. This means that standards are drafted by experts on
ASTM Committees and members vote to accept or reject the drafts until consensus is
reached. It is an open process following a defined procedure and any member of
ASTM may vote.
Consensus standards have the advantage of involving the real experts (where the
regulators sometimes have difficulty) and the process of standard setting is less labour
intensive and faster than when the regulatory bodies create standards.
2. What is the content of this Standard? What is the regulatory impact? Is it
accepted by the regulators in US and Europe?
ASTM Standard E 2500 was approved in the second quarter of 2007 and can be
bought from ASTM at on www.astm.org.
It describes a risk-based and science-based approach to the specification, design, and
verification of manufacturing systems and equipment (Quality by Design) that have the
potential to affect product quality and public health. The standard seeks to ensure such
manufacturing systems and equipment:
are fit for purpose
support continuous process capability improvements
enable innovation
consistently meet defined quality requirements
the verification process is efficient and effective
The key concepts are described along with the process itself and other supporting
processes.
In a significant change of approach to traditional qualification, the standard encourages
the adoption of Good Engineering Practices by equipment suppliers who have an
acceptable quality system This then allows customers to adopt the vendors
documentation which substantially meets the requirements for verification (replacing
traditional IQ and OQ) and so verification may be carried out in large part by an
appropriate assessment of the suppliers execution, construction, installation and
verification activities.
The FDAs legal framework allows it to use consensus standards if they meet its needs.
ASTM standards relevant to the pharmaceutical industry have the same status as
regulatory guidelines, i.e. they are for guidance only, companys do not have to follow
them and may choose not to use them.
The FDA has publicly endorsed the ASTM standard setting process but so far there
has been no public comment from the EU regulators.
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3. What is the definition of verification?
The standard defines verification as Confirmation through the provision of objective
evidence that specified requirements have been fulfilled.
It therefore recommends that verification activities should focus on those aspects or
characteristics of manufacturing systems that are necessary to control the
manufacturing process to ensure consistent product quality. These in turn are derived
from a scientifically sound understanding of the process.
4. Does the standard have influence on the relationship between the customer and the
supplier?
The net effect of the approach described in the standard is to bring closer together the
supplier of the equipment and/or system and the customer.
The suppliers will be expected to have a defined quality system and have adopted
Good Engineering Practices (to be defined in a forthcoming Guide form ISPE) and the
customers (after satisfactory supplier assessment) will then rely on these to be able to
adopt the verification documentation from the supplier instead of producing it all
themselves.
It is necessary to point out however, that not all verification activities can be completed
by the supplier. Some tests may necessarily still be carried out by the customer at his
premises and the customer still needs to complete the acceptance activities.
The standard recommends that the Acceptance Criteria are defined by Subject Matter
Experts and approved by the Quality Unit. After the verification documentation is
completed, it should be reviewed by independent Subject Matter Experts and if
satisfactory, the system may be accepted and released for use.
5. How can you use it in the field of CV?
The standard is directly applicable to computer and control systems used in a GxP-
regulated environment.
6. Does it have any influence on GAMP 5?
GAMP 5 when it is published will have been developed following adoption of the
principles of this new standard.
7. Does the new approach reduce the costs of qualification/validation?
This new approach when adopted in full should significantly reduce the cost of
traditional qualification/validation activities. By relying for verification of a suppliers
quality system and documentation, much testing, traditionally duplicated, should be
eliminated leading to significant cost savings.
In those cases where this approach has been adopted, very significant reductions in
the costs over the traditional qualification approaches, and to project timescales have
been achieved (over 50% has been claimed in some cases).
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