GMP Auditing of Active Pharmaceutical Ingredients (APIs) & Excipients

About The Course:

This comprehensive course provides attendees with the essential knowledge and skills to conduct effective GMP audits of pharmaceutical API and excipient suppliers. Participants will gain a thorough understanding of GMP principles, the specific requirements for API and excipient manufacturing, auditing techniques, and post-audit activities. Through interactive sessions, case studies, and practical exercises, participants will learn how to plan and execute audits, classify observations, and report findings accurately. The course will cover the nuances of API and excipient GMP requirements, enabling participants to assess supplier compliance effectively. Furthermore, attendees will learn about post-audit activities such as evaluating corrective actions, conducting follow-up audits, and managing supplier relationships. This course is ideal for professionals involved in regulatory affairs, quality assurance, auditing, and supplier management, working in the pharmaceutical industry. By attending this course, participants will enhance their auditing skills, contribute to product quality and patient safety, and ensure regulatory compliance with respect to API and excipient suppliers.

Why You Should Attend:

Without proper GMP auditing of API and excipient suppliers, your organization is at risk of compromised product quality, regulatory non-compliance, and potential harm to patients. Stay ahead of the game by attending our comprehensive training, where you'll gain the essential skills and knowledge to effectively assess supplier compliance, identify critical issues, and ensure the safety and efficacy of your pharmaceutical products. Don't let inadequate auditing practices leave your organization vulnerable to costly recalls, damaged reputation, and regulatory penalties. Join us and empower your team with the expertise needed to navigate the complexities of API and excipient manufacturing, mitigate risks, and maintain a robust supply chain. Invest in this training today and safeguard your organization's success, customer trust, and most importantly, the well-being of patients relying on your products. The consequences of neglecting GMP auditing can be severe, so don't wait until it's too late. Take action now and secure the future of your pharmaceutical operations with our industry leading GMP Auditing course.

Who Should Attend:

Quality Assurance (QA) Departments
Quality Control (QC) Departments
Regulatory Affairs Departments
Supplier Management Professionals
Auditing Professionals
Manufacturing Departments
Engineering Departments
Operations Departments
Production Departments
Compliance Professionals
Everyone responsible for ensuring GMP compliance and product quality

AGENDA:

Lecture 1 – Introduction to GMP Auditing

Overview of GMP principles and their significance in the pharmaceutical industry
Introduction to GMP auditing and its role in supplier qualification and quality assurance.
Regulatory requirements and expectations for GMP auditing of API and excipient suppliers

Lecture 2 – API and Excipient Manufacturing Processes and Requirements

Understanding the differences between API and excipient manufacturing processes.
Specific GMP requirements for API manufacturing
Specific GMP requirements for excipient manufacturing
Common challenges and compliance issues in API and excipient manufacturing

Lecture 3 – Auditing Planning and Preparation

Defining the scope and objectives of supplier audits.
Developing audit plans, checklists, and protocols.
Conducting risk assessments and prioritizing audit activities.
Preparing necessary documentation and conducting pre-audit activities

Lecture 4 – Conducting the Audit

Opening meetings and establishing rapport with suppliers.
Facility tours and observation of manufacturing processes
Document reviews and data analysis
Conducting interviews with key personnel.
Techniques for effective communication and maintaining objectivity during the audit

Lecture 5 – Audit Reporting and Documentation

Structure and content of audit reports
Classifying and documenting observations and findings
Evaluating non-conformances and identifying opportunities for improvement.
Reporting audit findings to stakeholders

Lecture 6 – Post-Audit Activities

Corrective and preventive actions (CAPA) management
Follow-up audits and assessing the implementation of corrective actions.
Supplier relationship management and communication strategies
Continuous improvement and lessons learned from audits

Lecture 7 – Case Studies and Group Exercises

Analyzing real-life scenarios and case studies related to API and excipient supplier audits

GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers