Biologic agents are used in high volumes in oncology and auto immune diseases. The FDA acknowledges that at times, patients require different concentrations due to each patient’s genome. Outsourcing facilities are permitted to repackage biologic agents in order to meet personalized dosages and reduce waste. The FDA Biologic Guidance allows 503B facilities to engage in the dilution, mixing and repackaging of biologic agents without a BLA license. Biomed Innova has a clear understanding of what is required for product validation, including stability processes and quality control for product release.
Pharmaceutical drug products deliver over 446 billion dollars of revenue annually in the United States. The FDA is tasked with protecting the public by minimizing the risks to consumers and ensuring that all medications are safe.. Drug manufacturers are required to apply and implement the regulatory and quality standards of CFR Title 21 CFR Part 210 and Part 211. Pharmaceutical organizations must focus on many areas including the following: management of manufacturing plant(s), engineering controls, equipment, aseptic techniques, productions, labeling, storage, shipments, laboratory controls, quality control and quality assurance.
Biomed Innova is set up to work with pharmaceutical companies specifically in quality control testing and in-process and final product release testing. As a cGMP and FDA registered laboratory, Biomed Innova treats quality as its most important objective.
In 2013, President Obama signed the Drug Quality and Security Act following the FDA‘s request to manage compounding facilities. As a result, the FDA created a new list of registered pharmacy manufacturers called 503B Outsourcing Facilities. The Interim Guidance document provides the provisions and covenants required by outsourcing facilities. The quality and regulatory requirements are detailed following the quality standards of 21 CFR Part 210 and 21 CFR Part 211.
Outsourcing facilities are allowed to manufacture compound sterile and non-sterile non-commercial formulations, repackaging, drug shortages production and dilute, mix and repackage Biologic Agents. All products produced are expected to go through product validations, stability testing and finished product release testing. Biomed Innova seeks to assist outsourcing facilities with the quality and regulatory requirements as demanded by the FDA for patients’ safety and the trust of healthcare practitioners.
Quality and Affordable Laboratory Testing