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Technology Transfer


Technology Transfer

It is very important to ensure the drug product retains its intended Critical Quality Attributes when transferred from the development phase to commercial manufacturing. This is done by identification of Critical Process Parameters and establishing them during 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 analytical laboratory to Quality testing (QC) laboratory through proper protocols & reports.

The manufacturing site transfer of commercialized product also involves critical steps like identification of the Critical Quality Attributes of the product to be transferred, identification of the critical process parameters, identification of the working principles of the equipment’s / machines involved in the manufacturing, comparing the working capacities of sending and receiving units, assessing the impact of the changes in any of the above aspects on the product quality.

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.

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.

Big things have small beginnings! We know how to scale up !!

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