You are thrilled to hear your manufacturing technology group has finished designing the process for your new product in the nanotechnology space. The process is stable and reproducible at a pilot scale. The toxicology studies are in, and your clinical trials are getting started with terrific promise. You are on the cutting edge of the next generation of drug products. This means success not only for your organization, but for the future of healthcare.
The commissioning of a facility, equipment, or system for operation under GMP regulations involves qualification that all operations are suitable for the intended purpose. The facility owner must have traceable verification of the systems, minimizing punchlist items to improve start-up and eliminate problems up front.
The FDA’s Software Precertification Pilot Program moves away from the agency’s long-held stance that it does not “approve companies,” exploring new thinking on how to regulate by reputation and continuous improvement loops, rather than reviewing each and every low-risk product. Might there be a way to replicate this type of thinking for complex products?
This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.
Chief Editor’s Note: An Outsourced Pharma reader asked if we could do an article on the handling of incoming bulk drug substance: "The regulations are fuzzy, at best, and I haven’t been able to find any articles recently that cover the topic.” One of our contributing authors, Bikash Chatterjee, took on the challenge …
Advancements in technology drive continuous improvements in thrombectomy techniques. But, the competitive landscape is subject to change very rapidly, given the release of Medtronic’s aspiration system.
This article emphasizes the importance of implementing a regular routine maintenance for inductively coupled plasma mass spectrometry (ICP-MS) equipment, so problem areas associated with instrumental components that are most susceptible to sample blockage, drift, and signal instability can be avoided.
Testing for evidence of microbial contamination in bioprocessing has a long history — and can be expensive, slow, and burdensome. So suppliers, testing facilities, and regulators have been seeking improvements.
Looking forward, the U.S. pharmaceutical industry needs to be aware that the despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
Part 2 of this two-part article reviews lessons from Spark Therapeutics’ pivotal program for Luxturna, a gene therapy approved for the treatment of patients with retinal dystrophy associated with confirmed biallelic mutation in the RPE65 gene, and summarize key considerations for the clinical development and commercialization of gene therapies.
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