Wednesday, February 11, 2015

Quality Agreements: Contractual Commitments by CROs to Deliver High-Quality Work

Authors: Susan Callery-D’Amico is Vice President, R&D Quality Assurance at AbbVie, Inc. and Tom McGrady is Vice President, QA/RA at Pharma Start


Regulated companies have been using formal agreements for years to define the respective quality roles, responsibilities, specifications and key performance indicators between organizations. For companies that outsource manufacturing operations, the FDA and other health authorities routinely review evidence of formal Quality Agreements during inspections. Prior to formal guidance from health authorities, many companies adopted the use of Quality Agreements as best practice, resulting in each company independently developing their own processes and templates.

The need for Quality Agreements can be traced to the ICH guidance documents Q9 Quality Risk Management (ICH Q9), which recommends supplier evaluation through audits and supplier Quality Agreements, and Q10 Pharmaceutical Quality Systems (ICH Q10), which states that the control and review of any outsourced activity are ultimately the responsibility of the sponsor. The tenets of these ICH guidance documents for industry are to build quality into processes and products (Quality by Design) rather than relying on end-product testing or inspection (Quality by Inspection).

It was not until May 2013 that the FDA issued a draft guidance, entitled Contract Manufacturing Arrangement for Drugs: Quality Agreements. In the absence of a requirement for quality agreements between study sponsors (Sponsors) and contract research organizations (CROs), we can look to this draft guidance and the ICH guidance documents.

Before creating a quality agreement, answer the following key questions:
  • • What is the regulatory basis for Quality Agreements and where can we find current guidance?
  • • What is the definition of a Quality Agreement?
  • • What are the essential elements of a Quality Agreement and the typical process flow between the Sponsor and the CRO or other contracted entity?
  • • Where does the Quality Agreement fit into the matrix of contractual agreements and the Sponsor’s supplier qualification program?
See Tom McGrady’s and Susan Callery-D’Amico’s article, “Quality Agreements: Contractual Commitments by CROs to Deliver High-Quality Work,” recently featured in the Journal of Clinical Research Best Practices.

This article is presented by Partnerships in Clinical Trials partner The Journal of Clinical Research Best Practices.  PCT will take place April 22-24, 2015 in Boston,  As a reader of this blog, when you register to join us and mention code XP2000LI, you can save $100 off current rates.




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