Product quality is the responsibility of all parties involved in the development, manufacturing, testing, packaging, distribution and regulation of materials that make up the clinical or commercial drug product.

“outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party”

Make sure you have TA in place with:

  • Contract Warehouse
  • Main suppliers (if not with all)
  • Customers (especially if collection by EXWorks)
  • Logistic providers (responsibilities and temperature control)
  • Your contract RP (must be correctly defined and specified in the procurement and supply as what activities to be performed and managed by the RP.)
  • Pest Control provider
  • Authorised Destruction provider etc.

Managing your contract acceptor/giver by:

  • Knowledge (audits, due diligence, bona fide)
  • Control (technical or quality agreements, ongoing oversight)
  • Formal process for controlling outsourced activities
  • Risk management
  • Continuous improvement