A contract between a GMP Contract Manufacturer and a pharmaceutical firm is a Quality Agreement and it details responsibilities of both parties by assuring the safety, efficacy and quality of the drug that has been manufactured. Recently FDA and the EU issued regulatory guidance which aims in bringing out some consistency as well as clarity to some quality contracts such as:
- EU GMP Chapter 7 “Outsourced Activities” (Revised)
- Draft Guidance for Industry – “Contract Manufacturing Arrangements for Drugs: Quality Agreements” May 2013
The global contract manufacturing organization (CMO) market in 2010 was estimated to be at $26 billion, increasing by 10.7% since 2008. This increased outsourcing in the pharma industry as well as recent quality issues with CMOs that have been well publicized, has brought out the importance and need for having an excellent quality oversight into external manufacturers so that GMP compliance is assured. Quality Agreement will be used as a tool to accomplish this objective.
To control CMOs and other such suppliers has always been a requirement of FDA and EU. Issuing these new regulatory documentations has fueled an exception that this control will have written documentation and proof of the control can be presented to EU/FDA inspectors as Quality Agreements specific to particular CMO.
Why You Should Attend :
This session is aimed at providing a clear understanding of the content expected in Quality Agreements from a regulatory perspective. Roger will fully analyze each section of the proposed Quality Agreement suggest appropriate content each while taking into consideration the new guidelines. The webinar will also provide a comparison of both the regulatory documents, and highlight and discuss the differences.
We will get into the details of quality agreement, including change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Lastly, he will provide insight on the latest status of FDA draft guidance and review comments from the industry.
- The Who and What of a good Quality Agreement
- What a Quality Agreement is and isn’t?
- Responsibilities of the owner vs. contract facility
- GMP responsibilities
- A comparison of the new guidelines from the FDA and the EU
- Quality Assurance Departments
- External Manufacturing / Outsourcing Departments
- Quality Auditing Departments
- Technology Transfer Departments
- Regulatory Affairs / Compliance Departments
- Supply Chain Departments
- Purchasing Departments
- Risk Management Departments