Medicines and other healthcare products rely on a delicate balance between quality, safety, and efficacy for their value, integrity, and commercial longevity. When this balance is disturbed by issues such as product adulteration, the damage to patients, revenues, and corporate reputation can be substantial. That is why the pharmaceutical and medtech industries, along with their associated regulators, are paying increasing attention to testing requirements for extractables and leachables (E&L).
Recent trends in product development and manufacturing have multiplied the risks of unintended chemical changes that could compromise product integrity, either during the manufacturing process or while the product is on the shelf. Extractables and leachables are organic or inorganic chemical compounds that have the potential to migrate into finished products from various sources. These sources include the container, container closure, delivery system, primary, secondary, and tertiary packaging, as well as various manufacturing components.
This whitepaper highlights the critical importance of robust E&L testing protocols. It provides detailed guidance on the regulatory requirements and best practices for identifying, quantifying, and mitigating the risks posed by extractables and leachables. By understanding and implementing effective E&L testing strategies, professionals in the pharmaceutical and medtech industries can ensure the safety, quality, and efficacy of their products, safeguarding patient health and maintaining regulatory compliance.