Consulting Service
Unique Service for Innovation Needs
Unique Service for Innovation Needs
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.
USIN can help you with the:
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.
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.
USIN TAIWAN supplies Validation Consultants at an hourly rate basis or for longer term project alternative arrangements can be made. Whether it is an existing facility, or a brand new facility manufacturing pharmaceuticals, medical devices or biologics; our Validation Consultants can navigate their way through the regulations and help you set up a compliant but practical validation approach.
The regulator's expectations of how validation is performed are continually changing, it's no longer acceptable to have filing cabinets filled with validation documentation and at the same time have regular in-process and final product testing failures. Our regulatory knowledge, practically applied' approach to compliance means that we won't over-engineer your validation efforts.
Good business sense and regulations advocate that product development should be controlled and developed within a GMP / GLP quality framework. This quality framework and written records are crucial to facilitate validation later. The general expectation is that products in clinical trials should be controlled within a GLP environment, many aspects should be fully validated, i.e. sterility assurance, or computer systems validation holding medical records.