Regulation, Analytical, and Process Issues with Leachables: Toward Harmonization for Latin America with Europe and North America

The pharmaceutical industry follows strict regulations regarding impurities, including process-related leachates. Plastic manufacturers use hydrophobic, nontoxic additives for manufacturing containers for use in the pharmaceutical and food industries. However, some issues about dealing with such impurities are not yet resolved. In developing countries, regulators are working on guidelines to help local companies ensure characterization of impurities.

In this exclusive editorial eBook, authors from Mexico describe some issues related to plastic leachables in the context of ongoing efforts to harmonize regulations between the United States, European Union, and Latin America. They offer solutions in accordance to the “state in the art techniques” to fulfill this important gap in pharmaceutical industry.

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