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18 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m APIs P rior to the commercialization phase for API manufacturing, there is a lot to juggle as well as a tricky global regulatory landscape to navigate. API manufacturers must meet the standards for the country where the drug will be distrib- uted, and every country has their own regulations as well as their own interpretation of those regulations. "Ahead of commercialization, regulators expect pharmaceutical companies to document a robust manufacturing process. The pro- cess must be validated prior to commercialization, and the data and a succinct discussion must be available for regulatory assessment," says Jakob Bonde, head of regulatory affairs, small molecules (DS and DP)/ associated regulatory affairs director, Lonza. "The validated process should implicitly reflect the required process knowledge for control of materials, impurities, and physical properties, as well as stability of the API. A good manufacturing and development partner can help speed this process by ensuring that the right data are provided in ap- plications, and the relevant details on materials are included." According to Steven Lynn, RCA executive VP, pharmaceuticals, and Susan Schniepp, RCA distinguished fellow, Regulatory Compliance Associates, well-documented standard operating procedures are a must, which includes information about personnel, facilities, equip- ment, and documentation as well as the responsibility for all produc- tion activities. Everything must be clearly defined and documented at each step. They add that following the proper quality management system (QMS) will ensure companies adhere to API standards. Global Regulatory Approach to API Manufacturing Meg Rivers Navigating a complex global regulatory landscape involves upfront research into the expectations of the different regulatory bodies, thorough documentation of every step of the API manufacturing process, and good communication. MAGELE-PICTURE - STOCK.ADOBE.COM