QMC provides consulting services to design, implement, optimize, and validate regulated pharmaceutical processes and methods.  Our Process Validation experience includes processes for manufacturing, cleaning programs, final product shipping, and analytical test methods.  We can assist with all stages of the process development timeline, starting from the early stages of commercial process development, Phase III clinical production and process characterization, through final process validation and preparation for launch.

QMC consultants have experience with sterile processes, cytotoxic suites, and biopharmaceutical products.  We can also provide services for the supporting systems and functions essential to your process.

§  Process Validation Master Plans

§  Validation of Production Processes

§  Optimization and Validation of Quality Control Test Methods

§  Facilities and Utility Systems Validation

§  Equipment Validation

§  Controlled Temperature Storage Validation

§  Cleaning Validation

§  Sterile Filter Validation

§  Shipping Validation

§  Stability and Hold Time Validation

Our services incorporate years of industry experience with a thorough understanding of regulations governing development, manufacturing, and testing of drugs and biologics.  Our system-wide approach to process validation provides our clients with the assurance of consistently successful validation of any regulated process.