Quality Agreements — Their Relationship to Microbiological Issues
Tuesday July 24, 2018
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D. (more about the instructor)
Written Quality Agreements are not explicitly required under existing CGMP regulations and do not relieve either party of their responsibilities under CGMP regulations or under the FD&C Act 501(a)(2)(B). However, Owners and Contracted Facilities can draw on quality management principles to initiate the complicated process of contract drug manufacturing by defining, establishing, and documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support operations. Accordingly, FDA recommends that Owners and Contracted Facilities implement written Quality Agreements as a tool to delineate responsibilities and assure the quality, safety, and effectiveness of drug products.
The legal framework for Quality Agreements includes:
501(a)(2)(B): A drug is adulterated if…methods used in, or facilities or controls used for, manufacturing, processing, packing, or holding do not conform with CGMP.
In addition, the relatively new FDASIA includes a section which involves CGMPs and the role played by both the Owner and the Contracted Facilities. FDASIA § 711 “CGMP” includes “the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products.” It explicitly links CGMP to quality management activities. Several ICH documents also speak to Quality Agreements and include ICH Q7, Q9 and Q10.
Quality Agreements also outline critical roles played by both Product Owners and Contracted Facilities, and explains how manufacturers should use Quality Agreements to define, establish, and document their responsibilities. It emphasizes that Quality Agreements should define parties’ responsibilities, assure full CGMP conformance, and facilitate consistent delivery of safe and effective medicines.
“Owner” and “Contracted Facility” are deliberate choices within the terminology of the Quality Agreement. A Quality Agreement is a comprehensive written document which defines and establishes obligations and responsibilities of Quality Units of parties involved in contract manufacturing of drugs subject to CGMP. The terms “Supply Agreement” or “Technical Agreement” or other possibilities are specifically excluded.
The objective of this live, interactive Executive Conference Corporation webinar is to obtain an enhanced understanding of this FDA Guidance for Industry “Contract Arrangement for Drugs: Quality Agreement”, and to assure that Companies are engaging in compliant drug manufacturing. A review of Case Studies/Warning Letters pertinent to both the contracted facility as well as the Product owner that involve the laboratory and microbiological issues will also be presented to enhance this webinar.
By attending you will learn about the following:
- About the NEW FDA Guidance for Industry Contract Arrangement for Drugs: Quality Agreement
- Understand the Definition of a Quality Agreement
- Learn about the Legal Framework behind Quality Agreements
- Learn what the Regulations are that Support Quality Agreements
- Learn What is and What is not Covered within the Scope of a Quality Agreement
- Understand the Purpose of a Quality Agreement
- Observe Several Hypothetical Scenarios and the Common Problems that Occur within Contracted Manufacturing Arrangements
- Learn how Quality Agreements are Responsible for Data Integrity in Laboratory Records and Test Results
- Learn how Quality Agreements Impact Microbiological Issues within the Laboratory
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-042