Getting an independent GMP review of your facility design is a great insurance policy – before the concrete is poured or you’ve signed the property lease.
We’ve known several companies who’ve spent a lot of money on remediating their facility after it’s been completed in order to meet GMP requirements. They could have saved that money by getting a GMP review of their design before construction started or before they signed the lease agreement.
Design reviews and qualification of facilities and equipment
PharmOut can help you with the:
- design review
- selection, and
of facilities and equipment.
Our experienced GMP engineers can review your facility design or develop plant designs in conjunction with your construction company. They will ensure that you comply with the relevant GMP guidelines / standards and can interpret the GMP guidelines to suit your product type and the markets you supply product to.
HVAC and air handling systems are a particularly critical aspect to get right. PharmOut offers the services of our consultant, Gordon Farquaharson, who chaired the ISO committee that wrote the standard on HVAC systems for clean rooms.
Balancing operational efficiencies and sustainability demands with GMP
As well as considering the GMP aspects of the design, our engineers may suggest design changes that will improve the efficiency of your operations or reduce GMP risk.
For example, with many companies trying to reduce their greenhouse emissions, keeping airflow running in cleanrooms, even during periods of non-use, is no longer acceptable. We recommend including a night-switch in the HVAC design so that the air flow can be reduced to the lowest level necessary to meet GMP requirements when the room is not in use.
Our consultants use their experience from many sites to ensure that critical parameters that impact product quality are considered during this process. We’ve seen what works and what definitely doesn’t.
PharmOut does not provide construction services, but we can help you select the best suppliers for the job.
We’ve been called in to help with remediation after a local supplier (with experience in building cold rooms but no GMP experience) completed a job at a GMP facility. The remediation cost far more than the cost of using a supplier with the right knowledge and experience in the first place.
Contact us to find out more about this service or to request a quote.