Transfer of Pharmaceutical Finished Product Processes to Third Party Manufacturers

Pharmaceutical companies routinely use third party manufacturers (TPMs) to manufacture their drug products, in addition to their own manufacturing sites. For currently marketed products, the technology transfer and implementation of the commercial process can be especially challenging since the equivalence of the manufacturing processes at the current and new sites needs to be demonstrated. The manufacturing process at the new site needs to yield final drug product which has the same quality attributes as the product from the current site. Process/product equivalence is also important to demonstrate for the required FDA and multinational registrations before the new site can be approved for manufacturing.

Examples of some challenges of technology transfer of pharmaceutical finished products to TPMs are given in case studies for three different pharmaceutical dosage forms - capsules, sterile liquid, and tablets. The capsule product was manufactured at two different in-house sites and transferred to a new TPM. The sterile liquid product was manufactured at the same TPM for 40 years and was transferred to a new TPM. The tablet product is still being manufactured in-house but is being considered for transfer. For this active project, there are currently six different TPMs under consideration due to the nature of the product and complexity of the manufacturing process (so only limited information can be shared at this time).