PharmOut can develop the whole engineering design package then supply the Quality Control (validation) to ensure the construction of a GMP compliant facility, service, equipment and process.
This starts with the initial engineering concept design, starting with your product and market requirements, documented in a User Requirements Specification. Our experienced pharmaceutical engineers will work closely with your team to develop the most appropriate facility design based on your process requirements, with a clear objective of achieving GMP compliance.
Our engineers are experienced with equipment selection, advantages and disadvantages of technologies and can advise on the best options, based on our industry experience.
We can either offer a complete project solution and manage the whole project or our Pharmaceutical Engineering offering includes the supply of individual engineers from the following disciplines, software, automation, chemical, mechanical, electrical as well as project managers. These services can be offered on a fixed price basis, hourly rates or as outsourced professionals on your site, under your direction, you choose.
Our complete GMP compliance, engineering and validation service will ensure a high level of confidence that the correct GMP target / standard is set, engineers design it right and our validation engineers ensure that the project quality control is done properly and GMP certification is assured.
Our GMP Engineers can review your plant / facility design or develop plant designs in conjunction with your current construction company? Need to ensure that you comply with the industry / engineering guidelines/ standards?
It makes good financial sense to have an independent review of your design before the concrete is poured!
Besides reviewing your design to GMP compliance, we have the experience and knowledge to ensure that your plant is designed for Economic Batch Quantities (EBQ), optimal work flows, Lean Manufacturing and World Class Manufacturing, for example.
A number of our staff are from production, quality and engineering disciplines and have practical knowledge of plant designs and can ensure proper facility design reviews.
Contact us for more details.