I am currently developing Quality Agreements, do you have any great sources to point me too?
I don't have any online resources to refer you too but I would recommend pulling from the Quality Agreements of your customers. Additionally/alternatively pull from ISO audit checklists and identified areas of risk/concern for your organization.
Donna, I am glad you have heard from Lance Coleman. He is solid and knowledgeable in auditing and agreements. My background is with Service Level Agreements. They are customizable to specific industries. The agreement will need to adhere to the standards regulating your area of the industry. Once you include requirements consistent with your regulatory bodies, then look to your company mission, vision, values, to make sure you and the new partner agree on ethics, outcomes, and financial expectations.
There are several guidance documents for Quality Agreements. For example, IPEC (International Pharmaceutical Excipient Council) has a guideline that is geared towards excipients. APIC (Active Pharmaceutical Ingredients Committee) has a template and guide for Quality Agreements for active pharmaceutical ingredients. Hope this helps.