Hello Everyone, My name is Donna. I am a Quality Systems Manager for a regulated Combo product start upl I'm looking forward to gaining information from this group and sharing too. I've worked in Big Pharma for 25 years and 4 years on the Combo side.

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.

Hi @DONNA DUNA - Welcome to myASQ & thanks for your post. I don't have any templates either. I did google Quality Agreement Template and several examples show in images.

@Grace Duffy , @Duke Okes - do you know of any resources?

Hope this helps

Trish

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.