Services

I guide you through all phases of your CMO relationship – before, during and after

Finding the Right CMO for Your Product

Beginning with a supplier evaluation – request for proposals, due diligence audits, etc. – I then define the appropriate CMO, including contracting and process transfer, as well as maintaining routine CMO management.
When highly potent drug substances (including cytotoxics) are involved, I guide you in fulfilling special requirements, including environmental, health, safety and quality aspects.

Product Transfer/ Person In Plant

Transferring a product to a CMO entails good manufacturing practice (GMP) and the corresponding documentation. Black Field Consulting has profound experience in the following areas:

• Qualification of equipment, buildings, media systems, rooms, etc. Including User Requirement Specifications, Functional Design Specifications, DQ, IQ, OQ, PQ. Risk Assessments and SOP generation
• Validation and approval of sterilization processes (dry heat, steam, vaporized hydrogen peroxide, gamma rays, filtration)
• Transfer, up-scaling and/or validation of manufacturing processes (including aseptic processes, liquid, lyophilization, dry powder products)
• Person In Plant manufacturing guidance: onsite evaluations of process viability and aseptic behavior; trouble shooting; yield improvement; suggesting non-conformance corrections and overseeing change control reports

Administration and Management

• Developing and applying lean tools and key performance indicators
• Managing long-range requirements; strategic capacity and contingency plan maintenance
• Monitoring and ensuring business continuity to reduce shortages (supplier risk)
• Negotiating and managing supply agreements
• Developing annual business goals, monitoring KPIs, generating reports for clients

Black Field Consulting supports you throughout your supplier relationship, establishing clear and fluent communication among stakeholders.