Q7A: Implementing Good Manufacturing Practices (T30)

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

Description

Biotech and pharmaceutical 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 USFDA's interpretation of ICH Q7, as defined in 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 biologics, and will review common deficiencies and problem areas related to Q7A. There will be a particular focus on equipment and engineering, and Q7 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. They will develop the ability to ask the right questions based upon science and the regulations knowing the relationship between this quality guidance for the production of APIs, and the good manufacturing practice (GMP) regulations applicable to the production of pharmaceutical and biologic finished drug products. We recommend participants have a basic understanding of the GMP regulations.

Course Topics Include

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

Course Modules

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

Take Back Your Job

• Know the fundamental elements, requirements and expectations of ICH Q7 for quality management, engineering and manufacturing systems management, and personnel actions for development and production of API
• Understand expectations and viewpoints of regulatory authorities using solid quality and scientifically sound systems and their interactions to ensure systems are designed, utilized, and documented to the level expected by regulatory authorities
• Review equipment and engineering operational issues to achieve recommendations for systems, controls, and procedures that can prevent potential errors for the production of APIs
• Understand the requirements and expectations for the production and control of all materials in the drug or biological drug product manufacturing stream
• Identify similarities and differences for the production and control of bulk active pharmaceutical ingredients from the current good manufacturing practices (cGMP) for the production and control of drug products

Attendance Recommended For

• Professionals in quality assurance, quality control, development and manufacturing, facilities engineering and maintenance, manufacturing equipment and systems design and production, and regulatory roles related to the production of API.
• A basic understanding of the current good manufacturing practices for drug product production would be helpful for best understanding of the elements in this course.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients 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.