The FDA evaluates the root cause of benzene contamination in certain drugs and alerts drug manufacturers to the risk of benzene contamination in drug components and other potential risk factors.
Drug manufacturers are responsible for ensuring the safety and quality of their drugs. As the FDA works to better understand the potential sources of benzene in drugs, the FDA reminds manufacturers of drugs marketed in approved applications and manufacturers of other drugs, including over-the-counter monograph drugs , their obligation to ensure that their products are of the appropriate quality. Features.
Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medicines. The CDER established thePharmaceutical Quality Office (OPQ)ensure a uniform drug quality program at all manufacturing sites, whether domestic or foreign, and in all areas of human pharmaceuticals – new drugs and biologics, generics, biosimilars, over-the-counter drugs and certain compound drugs.
The resources below provide information on pharmaceutical quality topics for manufacturers and requesters.
Quality information for applicants: chemistry, manufacturing and controls (NDA, ANDA, BLA and IND requests)
The following resources should be helpful to applicants and manufacturers who must have an application approved before marketing or conducting a clinical trial. They provide relevant information for various types of applications. Much of the technical and scientific information will also be useful to manufacturers of non-application drugs, such as over-the-counter monographs:
The following resources provide additional details for specific types of applications:
Improved product quality
The FDA is engaged in efforts to encourage innovations in manufacturing processes and technology and to foster a quality management system.
- Emerging Technologies Program: The FDA meets early with companies developing technologies that can offer significant improvements in pharmaceutical quality and provides recommendations to help support the development and implementation of technology and intended applications. The Emerging Technologies team looked at a wide range of new technologies such ascontinuous manufacturing,3D printing, Process analysis technologydistributed manufacturing and artificial intelligence.
- CDER FRAME (Framework for Regulatory Assessment of Advanced Manufacturing) Initiative : CDER is preparing a regulatory framework to support the adoption of advanced manufacturing technologies that could benefit patients. Based on commitments under the Emerging Technologies Program and elsewhere, the FRAME initiative has prioritized four technologies: continuous end-to-end manufacturing, distributed manufacturing, point-of-care manufacturing and use of artificial intelligence in manufacturing.
- International collaboration: The FDA engages foreign regulatory counterparts to coordinate ways to improve product quality. For example, we work with the International Council for Harmonization (ICH) to develop harmonized quality standards and facilitate their implementation by industry. The FDA is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which is an international organization dedicated to harmonizing inspection practices and related policies. The FDA has also engaged in initiatives such as theMutual Recognition Agreement Utilize inspection observations from relevant regulatory authorities, reduce duplication of effort, and focus resources and inspections on facilities that pose the greatest risk. Additionally, the FDA promotes engagement with global regulators under theInternational Coalition of Medicines Regulatory Authorities(ICMRA), which includes 28 regulatory authorities from around the world.
- ConOps: In June 2017, CDER and ORA established a Concept of operations(ConOps) to integrate human drug facility assessments and inspections. See our Questions/answers pagefor more details on how this collaboration will improve the consistency, efficiency and transparency of facility assessments and inspections and regulatory actions.
Quality Management Maturity (QMM): To increase transparency and encourage investment in mature quality management practices, CDER is developing a framework to objectively assess the QMM of pharmaceutical manufacturing sites. CDER’s QMM webpage explains the importance of QMM and provides information on the OPQ white paper, upcoming workshops and quality metricswhich are an important part of QMM.
- Quality measures: The FDA requires all drug manufacturers to monitor quality and drive continuous improvement. FDAquality measurement web pageprovides information on FDA’s efforts to initiate a voluntary reporting program that can provide key action to FDA.
Contact for more information: