Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA also played a major role in motivating international interest in the development of a "universal" API GMP.
ICH Q7A Guidelines ( later renamed by ICH as Q7 ) and practical approaches will be examined during this program. All the sections contained within the issued and internationally adopted Guidance will be surveyed and discussed, as only it can be by this actual author of the approved guidance. There are many consultants and "experts" that teach this subject, but almost none have first-hand knowledge of its development.
Some of the behind the scenes background will be discussed so that participants will be able to better understand the true intent of the expert work group`s negotiations. What are some key differences from Drug Product GMP and why were these differences established in Q7?
How should producers apply the guidance and how should users or purchasers of API utilize Q7 to their own benefit will be part of the subject matter. It is important to note that there are differences between drug product and API GMP and they need to be interpreted and applied correctly.
The nineteen Sections of Q7 and even the definitions used within the document have been carefully developed and written. This Webinar will help participants focus on the key parts and recognize where professional attention will benefit firms and organizations and where and when further training should be seriously considered.
Applying API GMP in the real world environment as intended by Q7 is as important as the guidance itself. Q7 has built-in flexibility in the application and intent of the API GMP which generally does not exist in drug product GMP regulations. The somewhat unique aspects associated with API is discussed and helps participants better under and apply these GMP.
Why should you attend: Are you new to the subject of API GMP, confused by the ICH Q7 Guidelines or how they should be applied by producers and suppliers of API as intended by the authors of Q7, then this Webinar is for you. This course, taught by one of the voting members of the Expert Work Group that negotiated this international guidance, will provide greater insight into the API GMP. Insight that only can come from a direct participant in the guidance`s development and negotiation. The program will identify which of the guidances sections that he considers most important, and how should they be implemented on a real-world basis. This is a rare opportunity to hear from and interact directly with a member of the ICH Expert Work Group that wrote Q7 and gain from his more than 40 years of experience in the drug and food additive related industries.
Areas Covered in the Session: - Impact of FD&C Act
- History of API GMP
- Use of 21 CFR Parts 210 and 211
- Nineteen Sections Surveyed
- Importance of Definitions in Q7
- Where is there Flexibility in API GMP Application
- What are key Sections
- Why the need for Q7?
- Are Q7 and 211 differences justified?
- What do producers need to do?
- What do purchasers of API need to do?
Who Will Benefit: - Quality Unit Supervisors/Managers/Directors
- Manufacturing Supervisors/Managers/Directors
- Support Functions to Quality or Manufacturing
- Regulatory Affairs personnel responsible for GMP Compliance and filings
- Support personnel responsible for GMP Related activities such as Calibration and Testing Functions
- Validation personnel
- R&D Professional, Supervision and Management
