Pharmaceutical Companies

The application of science based approaches to improve process knowledge and so robustness and efficiency, can be applied to both new products and those already in manufacturing. These tools are not new, but the use of them requires a philosophy change.

MWC can provide services ranging from assistance in building that philosophy, through to assistance on specific processes and products.

Understanding process capability (whether in R&D or Manufacturing) is key, and the use of risk management tools the solution. MWC can assist in the identification, definition, removal or control of risks.

During development the appropriate use of risk management within a Quality by Design (QbD) or design space philosophy, can lead to more robust and efficient processes and a reduction in the need to control in manufacturing.

If control is required, MWC can assist in the generation of application specific user requirement specifications (URS) and use its considerable experience and knowledge, to evaluate the vendor market to recommend the most appropriate solution. This could include determination of the capability of that solution, determining if it would be fit for use for alternate applications.

If a solution is not available, MWC can execute feasibility investigations, reviewing the suitability of emerging technology. If successful, MWC can also offer project management services during any resulting pharmaceutical company/instrument vendor development partnership, ensuring the compliance, as well as the capability, of any solution.