Search results for " GMP"
Article
Good Manufacturing Practices: Challenges with Compliance
…nufacturing?
Smith (Catalent): In general, it is not difficult to comply with the FDA’s GMP regulations, but there are some nuances that can present a challenge. For example, it is straightforw…
Article
Gowning Practices Provide Clues to cGMP Compliance
Quality must be built into the design of a facility to ensure that drugs are manufactured under conditions and practices required by the GMP regulations. This concept is broadly embraced across the gl…
Article
Viral Clearance Challenges in Bioprocessing
GLP and/or GMP?
Viral clearance studies, when performed by contract research organizations (CROs), are frequently performed following good laboratory practices (GLP) principles. Recently, however, …
Article
Advancing QbD in the EU
It makes clear that this new chapter will also apply to two existing pieces of EU legislation on the principles and guidelines of GMP—one, for medicines for human use, and other, for veterinary applic…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
…-free extracts and products at scale as well as having several products in clinical trials for which GMP compliance has been demonstrated, the professors state. Meanwhile, LenioBio, a Germany-based b…
Article
Understanding Validation and Technical Transfer, Part I
Following a series of inspections, FDA questioned the manufacturers’ ability to ensure sterility of these products, leading to the promulgation of GMP regulations for LVPs in 1976 (3). Although the LV…
Article
Advancing Single-Use Technology Through Collaboration
…MP) Expectations Gap, which was a type of industry outreach initiative to educate stakeholders about GMP (i.e., what it is, what documentation end users require from suppliers in order to comply with…
Article
Design and Qualification of Single-Use Systems
Fortunately, established SUT manufacturers have significant experience working with drug and vaccine companies and have learned to adopt SUT equipment designs to meet user needs in GMP-regulated proce…
Article
Implementing Inline Conditioning to Advance Process Intensification
We then moved to use the technology in GMP batches. We were fortunate in having a close collaboration with Cytiva and having their SMEs ready to support us, which was a great help during our journey
…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Automation, process integration, closed-system design, and compliance with current GMP can all be used to safeguard cell-therapy product quality.
Regulatory guidelines issued by FDA and other r…