Medical Products Laboratories, Inc. (MPL) uses a wide range of laboratory instruments to ensure that results are accurate and repeatable. Some of our testing capabilities include: high performance liquid chromatography (HPLC), Franz-cell, particle size analysis, Fourier transform infrared spectroscopy (FTIR), UV spectrophotometer, disintegration, and dissolution, as well as general wet chemistry for titrations, viscosity, specific gravity, specific ion electrode, and pH testing. All test methods are developed and validated to ensure the potency of the products meets label claim throughout the life cycle of the product. Whether USP, NF or other, MPL can meet specific customer requirements for raw materials. APIs for approved products are sourced with drug master files (DMF) and vendor qualifications are performed. MPL currently works with hundreds of excipients, and our highly experienced staff has the ability to develop a manufacturing process which will pair excipients and API(s) so label claims are met and the product remains stable.
Pilot and exhibit batches are manufactured and enrolled in accelerated, intermediate, and/or controlled room temperature storage conditions in accordance with ICH guidelines in order to obtain shelf life data. Our stability software maintains the program and provides updates at each test point. Our cGLP laboratory is also responsible for testing process, packaging, and cleaning validation samples submitted by the validation team.
The Quality Control laboratory is also responsible for supervising our duplicate DI water systems and air quality via our environmental monitoring program in conjunction with the validation team. All finished product lots are released with a Certificate of Analysis (COA) and/or Certificate of Compliance (COC). Safety Data Sheets (SDS) can be generated if required.
If you are looking for a cGMP-compliant CMO who specializes in the correct approach to research and development, MPL would be pleased to speak with you. Please submit a New Product Request Form today.