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SCALE UP AND TECHNOLOGY TRANSFER:
It is very important to ensure that the drug product retains the its intended Critical Quality Attributes when transferred from the development phase to commercial scale manufacturing. This is done by identification of the Critical Process Parameters and establishing challenging them during the scale up and validation of manufacturing process. A well-documented Technical Data Package helps in successful technology transfers. The analytical methods are also transferred from the analytical laboratory to the Quality testing (QC) laboratory through proper protocols & reports.
CONTRACT MANUFACTURING:
Propharmex provide integrated CDMO and CMO services through our trusted manufacturing partners for different dosage forms like; Solid orals (Capsules, Tablets, ODT, MUPS, Onco), Liquid orals (solutions, suspensions, PFS), parenterals (Vials, PFS, Lyo, Onco), topicals (creams, ointments & liquids), sterile Ophthalmics & personal care products.
We help Identify the right manufacturing partner with workable capacities and good quality systems.
We ensure cGMP compliance, product quality and timely supplies by regular visits and audits of our CMO partners.
SITE TRANSFERS:
Manufacturing site transfers involves, identification of CQA of drug product, comparison of working principles and capacities of the equipment’s / machines in use at sending / receiving units, assessing the impact of the changes if any on the product quality.