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Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 19 Lynn and Schniepp add that they have also seen many APIs designed to accommodate specific cus- tomer biological targets. As the science continues to improve, the industry will see new compounds even more potent than what we have today. Fur- thermore, they believe regulatory expectations will remain high in terms of hygiene control, bio- contaminants, and equipment validation. Drug shortages have long been a major concern for the bio/pharmaceutical industry; the COVID-19 pan- demic further magnified the importance of establish- ing a reliable supply chain for crucial materials. Easy availability of starting materials and other chemicals is important, says Mahender Rao Sirip- ragada, president, R&D, Neuland Labs, noting the importance of a short and de-risked supply-chain. All raw material supply companies should meet current good manufacturing practice (CGMP) requirements, and the API manufacturing pro- cess should be robust to have consistent quality. In addition, impurities should be controlled at all stages, including the source of formation, type of impurity (e.g., process impurity versus degrada- tion impurity), and control strategy for the impu- rities, Siripragada adds. Meeting quality and safety standards in a global market Regardless of where raw materials are sourced, API manufacturers with a global presence must adhere to the quality and safety standards of each country a drug product is distributed to. As such, it's no sur- prise that CGMP sits comfortably at the forefront. "The local in-country health authority acceptance of the active substance manufacturer's compliance to CGMP in a developed country, as documented in the manufacturing license and GMP certification, should be the main priority to meet global qual- ity standards. The safety standard is inherent with a high-quality standard," says Bonde. "Choosing a manufacturer in a country with global mutual recognition agreements in place, [and] bearing in mind regulators' increased use of risk-based assess- ments and desktop inspections, might reduce time to market while keeping quality high. The height- ened quality is ref lected in the source documenta- tion used to write the regulatory CMC [chemis- try, manufacturing, and controls] documentation, which will lead to fewer assessor questions." Lynn and Schniepp add that having strict and effec- tive QMS and quality risk management processes in place will help companies conform to whatever mar- ket they are involved in. Knowledge about the current global laws, regulations, and standards should be kept up-to-date and checked regularly since these stan- dards change. They also add that performing internal audits through the lens of global API laws, regula- tions, and standards allow manufacturers to identify and address any gaps or nonconformities they may have regarding specific markets. Moreover, International Council for Harmonisa- tion (ICH) guidelines should be consulted. Specifi- cally, Lynn and Schniepp reference the ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceu- tical Ingredients for thoroughness and clarity. API manufacturers must meet the standards for the country where the drug will be distributed, and every country has their own regulations and their own interpretation of those regulations.