Designing effective and efficient extractables and leachables studies assists in meeting the risk-based approach and industry regulations.
The best practices for pharmaceutical extractables and leachables testing are not prescriptive in nature. There is no standard protocol for the selection of solvents and conditions of contact. As a result, the design and protocol development is left to the pharmaceutical company.
Available choices in protocol development include:
- Which components should be tested?
- Should the components be tested separately or grouped together?
- What solvents should be selected? How many?
- What are the “worst case” extraction conditions (time and temperature)?
- What extraction techniques should be utilized?
- How many sampling points?
- Which extractables methods should be validated as leachables methods?
- Which targets should be selected for the leachables validation?
- Should an accelerated leachables study be used?
The answers to these questions can depend on the type of drug product, route of administration, composition of the packaging and manufacturing equipment. Budget and timelines for the regulatory submission must also be considered.
At Exova we help you to develop the extractables and leachables study plan, tailored to your specific needs. We understand the regulatory expectations for each type of drug product and, working closely with you, we help you to develop the most efficient testing protocols that meet the risk-based approach for these products.
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