Getting an independent GMP facility design review is a great insurance policy – before the concrete is poured or you’ve signed the property lease. We can provide reviews of facilities that are designed for ISO/ GMP / GLP compliance.
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 regulatory requirements. They could have saved that money by getting a 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, design review, selection, and installation of facilities and equipment.
Our experienced engineers can complete a GMP facility design review or develop plant designs in conjunction with your construction company. They will ensure that you comply with the relevant ISO/ GMP / GLP guidelines and standards and can interpret them 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.
Balancing Operational Efficiencies and Sustainability Demands with ISO/ GMP / GLP Regulations
As well as considering the regulatory aspects of the design, our engineers may suggest design changes that will improve the efficiency of your operations or reduce the facility 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 the relevant regulatory 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.
In the past we’ve been called in to help with remediation efforts after a local supplier (who had experience in building cold rooms but no GMP experience) completed a job at a GMP facility. The remediation cost post construction was far more than the cost of using a supplier with the right knowledge and experience in the first place.
Get in Touch
If you would like to learn more about our services, request a quote or ask any questions please fill out our enquiry form here.