CMO Management and Product Transfers

 
INDUSTRY
Pharmaceuticals
SERVICES
Validation
SKILLS
Change Control
Change Management
Product Transfer
Technical Transfer
Over 30 consultants provided throughout an eight-year relationship.
The Challenge

A third-party Contract Manufacturing Organization (CMO) management group was launching their business and recognized that they would need the right talent and expertise for a successful start. This organization is dedicated solely to working with CMOs, ensuring their compliance with cGMP regulations and other regulatory standards, including those from the FDA. They were referred to Oxford Global Resources by another organization and determined that we would be the right partner to help them achieve their goals on various initiatives, including product and technical transfer projects.

The Solution

We began to place senior-level consultants on an as-needed basis to act as a conduit between the client and the CMOs on several projects including:

  • Product and technical transfers of steriles, solids, ampules, liquids, OTC products, and APIs.
  • Handling the specific aspects of product transfers for products from CMOs to their clients, and evaluating and processing change control and change management.
  • Ensuring products were validated, monitoring any trends through continued process verification programs, supporting deviation and complaint investigations, and troubleshooting any manufacturing issues.
  • Improving process validation and going deep into the manufacturing processes to ensure cGMP and FDA compliance.
  • Re-validating mature products.
  • Providing Persons in Plant (PIP).

The primary goal was to ensure the CMOs were compliant with cGMP and FDA regulations, while also providing smooth product or technical transfers where applicable. To date, each engagement has run smoothly and efficiently.

The Result

Over the course of our eight-year relationship with this organization, Oxford has placed over 30 consultants on various assignments with many that are still ongoing. The track record of successful engagements have continued to strengthen our relationship, and they have designated Oxford as a preferred supplier of consultants. Several Oxford consultants have been hired on permanently, with others being placed on multiple assignments over time due to their level of expertise and ability to deliver results.