International GMPs and Quality Assurance

RCA6401 International GMPs and Quality Assurance (3 days)

Aims and Objectives

This subject has been specifically designed for Managers and Supervisors who are responsible for implementing or maintaining GMP Compliance and Quality Assurance in the manufacture of human or veterinary therapeutic products. It will also be of relevance to anyone with a general interest in GMP and is aimed as an introduction, concentrating on international aspects and quality assurance.

On completion of this subject students will be able to:

• State the underlying principles of GMP & Quality, their significance in the industry, and develop practical strategies to apply those principles in the workplace.
• Integrate GMP and ISO 9000 elements into a Quality System.
• Identify areas of GMP non-compliance and propose and implement corrective actions.
• Understand the scope of failure investigations in order to conduct and document effective investigations.
• Define the current trends in International GMP compliance.
• In addition, the participants are expected to gain an understanding of current requirements and future international trends within our industry.

Content

This subject consists of 6 modules or topics:
#1 QA Principle & International GMPs

• Historical developments of International codes of GMP (PIC/S, UK-MHRA, US -FDA and TGA) & their evolution into International Compliance.
• Veterinary codes of GMP - differences and similarities.
• Differences between regulations, codes & guides.
• Overview of Product Registration and Facility Licensing Processes.
• Review fundamental requirements for GMPs & the obligations of Manufacturers and Managers.
• Introduction to essentials for a GMP compliance program & introductory overview of the cGMP.

#2 Quality Management, Quality Assurance and Quality Control

• Definition of the relationship between Quality Assurance, Good Manufacturing Practice, Quality Control and ISO9000.
• G (QC) LP & its relationship with GMP.
• Release for Sale & Marketing Authorization.

#3 Key Quality Assurance Systems

• Reviews some of the critical QA and GMP systems e.g. requirements for:
• Deviation & Error Control.
• Corrective & Preventative Action (CAPA).
• An overview of Internal & External Audit Programs.

#4 Documentation Systems and Practices - GMP Requirements & Control

• Fundamental cGMP requirements for documentation, content, format & control.
• Structure & relationship between Manuals, Policies, specifications, SOPs, Work Instructions, Records & other supporting documentation.
• Discussion on a model hierarchical documentation system based on ISO 9000.
• Training is emphasized as well as the importance of documents & records during GMP audits.

#5 Change Control Programs

• Definition of change control.
• The differences between change control and document change control.
• Levels of change and responsibilities.
• Regulatory requirements and guidance.
• Some examples of change control - case studies and workshops.

• Review of cGMP requirements for managing complaints.
• Definition of product recall and product withdrawal.
• Definition of the different levels of recall.
• Review of cGMP requirements for managing recalls.
• Application of risk management strategies to recalls.
• Some practical examples of product recall.

Format

The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.