CMO Oversight

Programm

• Requirements and responsibilities
• Challenges and possible solutions
• Quality System aspects
• Supply Chain Maps
• Dealing with difficult CMOs
• GDP interface
• CDMO Oversight: case study on IMPs

• What does ‘Oversight’ mean?
• Applicable GMP requirements when working with CMOs
• Which are the essential Pharmaceutical Quality Systems (PQS) elements?

• The ultimate responsibility for the performance of a medicinal product
• Articulating MAH responsibilities in a complex organization
• Effective MAH governance

• What does CMO oversight mean and what is expected?
• What aspects of the supply chain are relevant and how is sufficient oversight achieved?
• How to handle more than one quality system
• How to manage differences in culture and language

• What is required of a Supply Chain Map (SCM)?
• Control and format of SCMs and setting the scope of responsibilities
• Achieving value from use of SCMs – and aligning company’s approach for supply

• How the PQS should interact with other companies’ systems
• Detailed review of possible points of interaction (e.g. change controls, deviations/non-conformances, complaints & recall, preparation of the Product Quality Review, audits……)
• How to ensure effective and efficient interaction and communication.
• What are the challenges to overcome?

• Arrangements for QP Certification at the contract giver
• Manage deviation reporting and change control implementation
• Batch Certification – Considerations for outsourcing
• Case studies, examples of effective arrangements

• Responsibilities
• Contract Development and Manufacturing Organisations (CDMO) selection and control
• Overview management
• Point of contacts
• Reviews and quality reports (external/ internal)

• Top 10 most difficult behaviours to handle
• Reasons
• How to increase engagement

• Triggers, figures and stickers
• Handling below satisfactory CMOs

• Objective of QRM and how best to use this tool
• When to use QRM proactively and how to ensure this is effective
• Examples of when QRM has to be used reactively and how to make informed, scientific decisions

• MAH’s responsibilities after certification and release of medicinal product
• Establishing arrangements for effectively managing defect reporting, potential market actions, supervisory authority engagement

• Reminder of GDP guidance available for APIs and products
• How this interface should work to ensure product reaches patient in suitable condition
• Challenges to overcome