A Scientific Approach to Good Manufacturing Practices

Contract Manufacturing Organizations (CMOs) represent an important and growing industry involved in the manufacture of active pharmaceutical ingredients (APIs) and drug products in a range of dosage forms. By nature of the end use of their manufactured goods, CMOs come under the oversight and responsibility of federal agencies in multiple regions and jurisdictions. These agencies use inspection and enforcement actions to ensure quality compliance and meet their responsibility to protect the public. As quality best practices continue to evolve and improve in response to technology and process advances, as well as in response to public health incidents, federal agencies have continued to challenge the industry to improve its quality compliance and mitigate risk of future incidents occurring. As a result, CMOs exist in an environment of continuous improvement and evolving quality standards that are a requirement of their existence.