CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

Why Should You Attend:

Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.

This webinar will provide a thorough understanding of the content that is expected in Quality Agreement from a regulatory perspective. Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration. Comparison of the two regulatory documents will be presented with differences highlighted and discussed. The latest status of the FDA draft guidance will be discussed and a review of comments from industry is included.

Areas Covered in the Webinar:

• The who and what of a good Quality Agreement
• What a Quality Agreement is - and is not
• Responsibilities of the owner vs. contract facility
• GMP responsibilities
• A comparison of the new guidelines from the FDA and the EU

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Quality Assurance
• External Manufacturing / Outsourcing
• Quality Auditing
• Technology Transfer
• Regulatory Affairs / Compliance
• Supply Chain
• Purchasing
• Risk Management

Roger Cowan
Pharmaceutical Consultant, R Cowan Consulting Services LLC

Roger Cowan, is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years’ experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.

Roger's areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.

Frequently Asked Questions:

1. Has there been discussion about when the FDA comment period end
2. where does one find a copy of the Comments from Industry?
3. would the FDA expect a contractor to have quality agreements with their raw materials suppliers in place as well?
4. In an early slide, what are the elements of "Knowledge Management"
5. Do you need to have a QA with a distributor that does not do any further GMP processing of the product - just warehousing and shipping?
6. What would be the strategy for managing a partner (license/collaboration agreement) who uses only CMOs to manufacture product to be used in clinical trials sponsored by my company - should we get QAs with the partner's CMOs or just go with the QAs between the partner and the CMOs
7. what if it’s a regulatory starting material or API starting materials/intermediates?
8. should the quality agreements be product or service specific or a blanket agreement should suffice
9. would a quality agreement be required in cases where CRO purchases material from an intercompany affiliate
10. Clients expect quality agreements with sister sites providing products and services to the host site. What are your thoughts?
11. what is the guidance for agreements b/w CMO and its vendors?
12. is the expectation to establish these agreements with all suppliers, or should it be based on vendor risk?
13. what is the guidance for agreements b/w CMO and its vendors? Would this be applicable to CROs also?

Topic Background:

In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well publicized quality issues with CMOs, make it a necessity to have excellent quality oversight of external manufacturers to provide assurance of GMP compliance. A Quality Agreement is one tool used to accomplish this objective.

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.

Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:

• EU GMP Chapter 7 "Outsourced Activities" (Revised)
• Draft Guidance for Industry - "Contract Manufacturing Arrangements for Drugs: Quality Agreements" May 2013

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