Objectives

Over the last years, the requirements on the assessment of substances that could leach into the drug product in the course of its life cycle have increased considerably.

The kind of leachable you would have to look for can vary from organic oligomers and catalyst residues to heavy metals - to name a few. Due to the resulting complexity, it is very important to consider the potential risk already at a very early stage in process development

Packaging materials have been in the focus of such investigations for a long time as the contact time between drug product and packaging material is rather long.

But in addition you have to consider other possible sources of contamination. Recently, particular attention was paid to devices and equipment used in the production process itself, e.g. filters, bags, tubes. The trend towards single-use equipment might relieve the pressure on cleaning validation. At the same time leachables/extractables testing will become a topic of major concern.

Within the scope of this GMP Education Course, all relevant aspects of FDA/GMP-compliant leachables and extractables testing will be addressed ranging from regulatory requirements to routine extractables testing in quality control.

Experienced industry speakers share their in-depth knowledge with you.

Target Group

The course is designed for personnel of pharmaceutical companies and their suppliers who

• are responsible for qualification of extractables/leachables in quality control.
• perform leachables/extractables testing.
• work in quality control of packaging materials.
• choose and define polymeric, glass and rubber materials in process development.

Registration

To register for this course please see the Registration Options.