This course is intended for pharmaceutical manufacturers to help them understand and apply criteria for the selection, qualification, and ongoing quality oversight of excipient manufacturers and distributors. The course is helpful to excipient manufacturers and distributors’, so they may learn and implement measures to address their customers’ and regulators’ requirements.
Audience Description:
> Quality professionals at drug product manufacturers with responsibility for supplier audit, supplier quality management, or excipient approval
> Quality professionals at excipient manufacturers and excipient distributors responsible for hosting pharmaceutical customer audit, responding to customer quality inquiries, and ensuring regulatory compliance
> Purchasing and supply chain professionals at drug product manufacturers responsible for selection and initial assessment of excipient suppliers
Learning Objectives
Upon completion of the course, participants will be able to:
> Describe general regulatory expectations for excipients in the US and Europe
> Describe and develop elements of a qualification program for excipient suppliers
- Locate and complete templates for Quality Agreements,
- Describe expectations for excipient Certificate of Analysis
> Describe special qualification requirements for procuring excipients through distributors
- Compare and explain the differences between different types of distributors and their operations
- List and discuss the resources available for learning about and assessing Good Distribution Practices
> Name some methods of determining essential quality/supply chain integrity characteristics of excipient distributors
> Describe and develop elements of a supplier quality management program of excipient makers by users
> Describe requirements for performance of ongoing assessments of conformance to GMP
Upon completion of the course, participants will be able to:
> Describe general regulatory expectations for excipients in the US and Europe
> Describe and develop elements of a qualification program for excipient suppliers
- Locate and complete templates for Quality Agreements,
- Describe expectations for excipient Certificate of Analysis
> Describe special qualification requirements for procuring excipients through distributors
- Compare and explain the differences between different types of distributors and their operations
- List and discuss the resources available for learning about and assessing Good Distribution Practices
> Name some methods of determining essential quality/supply chain integrity characteristics of excipient distributors
> Describe and develop elements of a supplier quality management program of excipient makers by users
> Describe requirements for performance of ongoing assessments of conformance to GMP