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It was not until May 2013 that the FDA issued a draft guidance, entitled Contract Manufacturing Arrangement for Drugs: Quality Agreements.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quality agreements between study sponsors (Sponsors) and contract research organizations (CROs), we can look to this draft guidance and the ICH guidance documents.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