From Parts 1 and 2 of this post we highlighted that there is no formal need for an Engineering Manager or Department in GMP. In the manufacture of medicines the equipment used and the environment it is located in has a massive impact on product quality. The role of the Engineering Manager is therefore critical. In a number of engineering related GMP courses that I have presented in the past we have looked at what the delegates think the Head of Engineering’s role should be, bearing in mind the role is not defined in EU GMP. Some of the roles already assigned in GMP to the Head of Production can be delegated to them, with additional roles added as well. Their findings are below:
The Engineering Manager (suggested duties from previous delegates)
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Maintenance of premises and equipment.
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Design of facilities.
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Validation and qualification of equipment and facilities.
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Management of the calibration programme.
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Management of the Planned Preventative Maintenance programme.
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Control and operation of site services (including water, steam and HVAC systems).
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Control of engineering spares/ equipment spares.
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Control of engineering contactors.
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Approval of engineering related procedures, documents and drawings.
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Control and storage of engineering records.
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Control of equipment manuals.
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Pest control.
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Site security and access.
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Project Management.
These are roles commonly performed by Engineering departments. They are opinions from former GMP training course delegates, and should not be seen as a specific GMP requirement. Please let us know what you think. Are these similar to your own Engineering department?
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Having performed this role at a major UK manufacturing site (aseptic, terminally sterilised, liquid, dry, human & vet products), I would add that a major contribution is in project management, both in terms of the facility and the equipment used.
Major facility expansion projects were generally run by a central project group (almost exclusively engineers), with a significant input from the site engineers. Upgrades, improvements and capital equipment purchase were almost always managed locally, with one of the engineering managers (site services or operational) taking the lead.
Of course, there were many other areas to which the role can contribute – efficiency improvements, lead time and stock reduction, etc. – especially where the incumbent has manufacturing experience from outside the pharmaceutical industry.
Bob Hayes, Vice-Chair, Pharmaceutical Technical Activities Committee, IMechE.
Good point Bob – post updated. Thanks for your comments.