The pharmaceutical industry is accustomed to operating in accordance with guidelines and procedures which ensure that products are manufactured to the required standards of safety and efficacy. Such guidelines have only recently started to be prepared for the engineering design process that prepares pharmaceutical facilities and equipment.
For a number of years, Aker Kvaerner have been preparing procedures and guidelines for project teams to ensure that facilities will be designed in such a way that operators will find it easy and natural to work in accordance with the principles of Good Manufacturing Practice. This approach is defined by Aker Kvaerner as ‘Engineering for GMP’.
The procedures that need to be applied will depend on project requirements, but typically include:
- Appointment of a 'GMP Compliance Manager' on a project to ensure that the good intentions are realised in practice
- Preparation of a GMP Philosophy early in the project that will define the levels of finishes, protection etc. appropriate to each stage of the manufacturing process
- Monitoring of the skills and experience of all members of the project team, and application of GMP Awareness Training where appropriate
- Workshops and consultancy to resolve conflicts between GMP and Good Engineering Practice, budgetary restraints, etc.
- GMP Reviews at appropriate stages in the project, comparing the design with the intent expressed in the GMP Philosophy
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