Quality and compliance are the guiding principles of SZ Para Pharma’s operations. Any activity performed within the organization is bound by our quality framework. Our facilities have a track record of successful audits conducted by authorities from across the globe among others
Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. CDER established the Office of Pharmaceutical Quality (OPQ) to ensure a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all human drug product areas – new drugs and biologics, generics, biosimilars, over-the-counter drugs and certain compounded drugs.
The resources below offer information on pharmaceutical quality topics for manufacturers and applicants.
The following resources should be helpful to applicants and manufacturers who are required to have an approved application before marketing or conducting a clinical trial. They provide information relevant to various application types. Much of the technical and scientific information will also be helpful for manufacturers of non-application drugs
Emerging Technology Program: sz para meets early with companies developing technologies that may offer significant improvements to pharmaceutical quality and provides recommendations to help support technology development and implementation and anticipated applications. The Emerging Technology Team has considered a wide range of new technologies such as continuous manufacturing, 3D printing, Process Analytical Technology, distributed manufacturing, and artificial intelligence.
CDER is preparing a regulatory framework to support the adoption of advanced manufacturing technologies that could bring benefits to patients. Based on engagements through the Emerging Technology Program and elsewhere, the FRAME initiative prioritized four technologies: End-to-End Continuous Manufacturing, Distributed Manufacturing, Point-of-Care Manufacturing, and the use of Artificial Intelligence in manufacturing.