Management on Outsourced Operations

Group Leaders:

Susan J. Schniepp
Vice President of Quality
Allergy Labs

Karen S. Ginsbury
PCI Pharmaceutical Consulting Israel

Mission:  The Management on Outsourced Operations Interest Group will provide a platform for sharing information among PDA members on management, oversight and regulatory responsibilities of outsourced activities, and, serve as the liaison between RAQAB and follow-up of the PCMO Task Force. 

Scope of the Interest Group:

  • To monitor regulatory developments, guidances and standpoints regarding management of outsourced activities
  • To support the preparation of position papers, Points to Consider documents, or a Technical Report on outsourcing as well as submission of articles to the PDA Letter; which may evolve from IG Meetings
  • To proactively identify ways of ensuring a global approach for integration of ICH Q10 using ICH Q9, and principles of Quality Risk Management in managing outsourced activities
  • To provide input to scheduling and content of PDA conferences and TRI courses on outsourcing.

2014 PDA Annual Meeting

The Outsourced Operations had a lively discussion at PDA Annual in San Antonio, Texas on 07 April, 2014.  The slide deck that was developed during the session is to the left of your screen, as is FDA’s draft guidance on Quality Agreements.  The main takeaways from the discussion, which this group hopes to develop over the coming year:

  • Develop a risk management  / risk assessment tool to ensure appropriate resources are assigned to manage risks associated with outsourced operations and allow development of control strategies and adequate oversight
  • Defining a project manager with assigned job description and adequate authority (documented) to do the job – both at contract giver and at contractor / contract acceptor
  •  Contract Giver: accepting the quality system post audit at the contractor – if you can’t do it you can’t assign the contract
  • Contract Giver: writing an Outsourcing Policy with most senior level management sign-off to ensure provision of resources for outsourced ops

As we develop the Outsourced Operations community on this site, please check in and let us have your input on the slide deck and on the takeaways so that we can plan future activities and deliverables around the needs of our IG members.