Q7A Essentials: Implementing Good Manufacturing Practices for Active Pharmaceutical Ingredients

ISPE CEUs*: 1.3
Type: Classroom Training Course
Level: Intermediate
Level: Advanced

This course can be offered at your company site in its current format or customized to meet the needs of your organization.

Description

Companies that manufacture active pharmaceutical ingredients (APIs) face a host of compliance issues unique to their processes. This course reviews and interprets the key GMP requirements specific to bulk biopharmaceuticals and familiarizes participants with the FDA’s interpretation of ICH Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

This course will cover areas in which compliance requirements differ most from traditional pharmaceuticals, and will review common deficiencies and problem areas related to Q7A. There will be a particular focus on equipment and engineering, and Q7A compliance issues, with recommended systems, controls, and procedures to avoid pitfalls. The course focuses on building solid GMP principles based on the concepts of quality assurance and using sound, scientific principles to build compliant systems. Participants will learn basic regulation information and practical utilization techniques – and they will develop the ability to ask the right questions based upon science and the regulations. We recommend participants have a basic understanding of the GMP regulations.

Course topics include:

• API GMPs History
• Introduction to API GMPs
• Scope of Q7A
• Quality Management
• Buildings and Facilities
• Process Equipment
• Documentation and Records
• Materials Management
• Production and In-process controls
• Specifics for Biotechnology
• Specifics for Clinical Manufacturing

Course Modules

• Reminders about APIs
• A Quick History of APIs GMP
• Quality Management
• Personnel
• Impact and Risk Assessment
• Building & Facilities
• Process Equipment
• Manufacturing Controls
• Qualification & Validation
• General Considerations Regarding Organization, Documentation & Production
• Cell Culture & Fermentation Specificities
• APIs for Use in Clinical Trials

Take Back Your Job

• Articulate fundamental knowledge of GMPs as framed by Q7A related to manufacturing operations
• Understand how regulatory authorities review manufacturing operations
• Understand how to anticipate problem areas before they create problems for a company
• Improve job performance
• Assess and understand the emphasis of current information regarding regulatory authority activities

Attendance Suggested For

• Professionals in QA, QC, manufacturing and regulatory roles that involve ensuring GMP compliance

Community of Practice (COP) www.ISPE.org/COPs

This training course is of particular interest to existing and future members of the ISPE API Community of Practice (COP).

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.