Starting materials – the GMP essentials

WEBINAR

Get the essentials of starting material requirements in GMP during this informative webinar. Both EU GMP requirements and US FDA requirements for APIs and excipients will be covered.

This is an independent continuation to the webinar “How to Qualify your suppliers in compliance with GMP” (11 Nov)

Course description

Regardless of the level of controls that have been applied on starting material suppliers, there are certain general GMP requirements that always needs to be in-place for each incoming lot of material.

This webinar contains a walk-through of the GMP requirements related to material specifications, minimal requirements for incoming controls and testing, aspects to consider related to Certificate of Analysis as well as requirements related to sampling.

Course outline

• Specifications for starting materials as required in GMP
• Necessary checks upon receipt
• Testing – what must be done and when can a Certificate of Analysis be used
• “Validation” of the Certificate of Analysis
• Sampling

Learning objectives

• Understand the different GMP requirements related to starting materials
• Discuss the necessary incoming controls
• Understand the basis for a reliable Certificate of Analysis
• Get insight in requirements and challenges related to sampling

Who should attend

This course is intended for professionals who are responsible for incoming starting materials from a GMP perspective. Purchasing and Quality professionals will benefit by learning the relevant requirements and how they relate to supplier controls.

Prerequisites

• At least Basic GMP Knowledge
• Some practical experience with supplier controls is beneficial
• It is a benefit to have participated in the Webinar “How to Qualify your suppliers in compliance with GMP” but this course can also be taken independently

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