In recent years, the requirements for assessing substances that can leach into a drug product over its lifecycle have increased considerably. As a result, the scope for assessing leachables can encompass everything from plastic additives, oligomers and catalyst residues to heavy metals.
Due to the resulting complexity, it is important to consider the potential risk factors associated with leaching substances during the early stage of process development. In addition, consideration must also be given to packaging materials and other possible sources of contamination, as well as devices and equipment (single-use system components) used in the production process itself, e.g. filters, bags and tubes.
In this three-day GMP Education Course, experienced industry speakers, including Dr Andreas Nixdorf, Business Development Manager at SGS Life Science Services, share their in-depth knowledge on Pharmacopoeia/GMP-compliant leachables and extractables testing. You will learn about a range of key issues, from regulatory requirements to routine extractables testing in quality control. Case studies will also be presented and discussed in detail.
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