Full Packaging Line Transfer from In-House to Contract

A major pharmaceutical company decided to divest its internal packaging operations as part of a broader strategic initiative to focus on core competencies. The transfer encompassed 8 product SKUs spanning multiple dosage forms and packaging configurations, each with established commercial markets and supply commitments.

The transfer required full technology transfer including process documentation, analytical methods, and equipment specifications. Validation activities spanning IQ, OQ, and PQ needed to be completed, along with stability studies and regulatory filing support for FDA site transfer supplements. The overarching constraint was zero supply disruption — patients and commercial customers could not experience any interruption during the transition.

Meridan executed a structured technology transfer program over 14 months, beginning with a comprehensive gap analysis and process characterization phase. The engineering team worked side-by-side with the client’s technical staff to document every critical process parameter, material specification, and quality attribute for each of the 8 SKUs.

Process validation activities were executed systematically, with installation qualification, operational qualification, and performance qualification completed for each product on Meridan’s equipment. Stability studies were initiated to support the regulatory filing requirements, with accelerated and long-term stability protocols established for each product.

Regulatory filing support included preparation and submission of FDA site transfer supplements (Prior Approval Supplements and Changes Being Effected supplements, as appropriate) for each product. During the transition period, Meridan operated parallel production capability, maintaining the ability to package product at both the original and new sites to ensure uninterrupted supply.