Leachables and Extractables

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 factors associated with leaching substances 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 also 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 and the need to introduce control strategies along the supply chain to avoid unintentional added impurities in materials. 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 Pharmacopoeia/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.