Active Pharmaceutical Ingredient Leadership Group

The mission of the Active Pharmaceutical Ingredient Leadership Group (API LG) is to advance science-based, phase-appropriate strategies for the industry that utilize efficient and sustainable processes to deliver high-quality API in alignment with Quality-by-Design principles and in compliance with regulatory guidelines.

The API LG drives innovation and quality in pharmaceutical development through the establishment and adoption of best practices. We share information within peer networks and with industry at large through peer-reviewed publications and presentations, and collaboration with regulatory agencies and other key stakeholders.

Activities

The API LG has placed an emphasis on understanding challenges and opportunities during development and manufacturing of API's through dialogue with key regulatory authorities, including FDA, and several different forums to enable the exchange of industry practices between the member companies. We currently oversee and participate in Working Groups (WGs) listed on the left side of the page.

As the API LG and its WGs continue to acquire knowledge, members will work with related IQ Working and Leadership Groups to develop and facilitate implementation of strategies and best practices to address and optimize industry practices for the manufacture of APIs.