Engineering Standards Enforcement
ISPE ESB COP
The Engineering Standards Benchmarking (ESB) Community of Practice (COP) Steering
Committee developed a survey to evaluate the methods used by the pharmaceutical industry in
the internal enforcement of their engineering standards. The survey was prepared and executed
by active members of the ESB COP Steering Committee in June/July 2010 and included
representatives from the drug manufacturers and engineering/construction and validation
service providers. The following summarizes the survey questions and the responses provided
by the ESB COP.
Engineering Standards are defined as procedures and/or guidance documents that define
general and specific requirements for the design and construction of equipment, utilities and
facilities used in the manufacture, packaging, testing and storage/distribution of drug products.
Without a doubt, the need to comply with a company’s internal engineering standards is an
expectation of both drug manufacturing companies and engineering service providers, as all
respondents confirmed that their company had methods/tools in-place to ensure compliance. It
was agreed that the most effective process is design review and/or design qualification.
Drug manufacturing companies rely on methods of “encouragement” and enforcement to
comply with the standards, with consensus and the majority of respondents stating, they rely on
the use of periodic design reviews or the design qualification process to confirm compliance with
the engineering standards during the design phase of the project. For most companies, project
gate reviews must be performed prior to advancing to the next stage of design. Although the
engineering service providers participate (and sometimes lead) the design review process for
the project, their internal procedures also rely on the process of auditing to confirm compliance
with the engineering standards prior to issue for construction (IFC) of drawings and
specifications. They have also found significant value added when the customer’s (drug
manufacturer) representatives from Health Safety and Environment (HSE) and Quality are
included in the auditing and design review process. This was noted as “Best Practice”.
The design reviews may focus on a number of different design attributes, including compliance
with regulatory requirements (FDA/EU, USP/EP), standards (ASME/BPE, IEEE, GAMP,
biosafety), industry guidance (ISPE, PDA), process safety and efficiency, but there was general
agreement that the aspects of GMP and process safety compliance were verified more
stringently. The group discussion indicated that the processes and methods for verification of
process safety (Haz Ops, Process Hazard Reviews, etc.) were more firmly entrenched as
recognized and established processes within their companies than the GMP verifications.
On a project by project basis, the User Requirements Specification (URS) and documentation
used to support design qualification defines the applicable engineering standards, regulatory
requirements and industry standards.
It was noted that most engineering standards were applicable to new construction only and
therefore often not applied retrospectively, except in rare cases.
The primary responsibility for ensuring compliance with the standards sits with the Project
Manager with some overlapping responsibility by Engineering, Quality and Validation
departments.
Where design review is the primary method used for confirming compliance with the
engineering standards, the most frequent responses indicated that the Project Design Leader,
Project Manager or C&Q Leader for the project had the responsibility for leading the design
reviews.
Preliminary engineering tends to be the starting point for the formal design review process or
what is defined in the companies design gate process. Some companies perform multiple
design reviews across the project, while others rely on the engineering company to continually
confirm compliance with the standards post the initial review.
It was agreed that sites appear to be “good” at performing “gap assessments” for new
standards, while concern was raised that the internal process for revision of standards was not
as robust. This area may require future exploration by the COP to determine best practice.
The design review process is intended to ensure compliance with the engineering standards,
when deviations are identified they are discussed as part of the review and the design is
modified to meet the standard. Although not a common event, a situation of non-compliance
where the design is not modified to meet the requirements outlined in the engineering
standards, does occur. Most companies rely on the project team to review, process and issue
variances for non-conformance that then require VP level approval of the variance. These
variances may often lead to the revision of engineering standards.
Little experience or few instances were known where companies experienced outside agencies
questioning the standards for compliance with the requirements, much less any regulatory citing
of the standards for compliance with GMP. Very few examples were known.
In summary, while most drug manufacturers and engineering/construction and validation
service providers have varied methods/tools in-place to ensure compliance with Engineering
Standards. The consensus indicates that the Design Review/Design Qualification of the URS is
the most effective method to ensure compliance, especially when this can be done in a crossfunctional environment.
If you are interested in creating/participating or analyzing future surveys such as this contact the
Engineering Standards Benchmarking COP.
January 2011