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)
- Maintenance of premises and equipment.
- Design of facilities.
- Validation and qualification of equipment and facilities.
- Management of the calibration programme.
- Management of the Planned Preventative Maintenance programme.
- Control and operation of site services (including water, steam and HVAC systems).
- Control of engineering spares/ equipment spares.
- Control of engineering contactors.
- Approval of engineering related procedures, documents and drawings.
- Control and storage of engineering records.
- Control of equipment manuals.
- Pest control.
- Site security and access.
- 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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