Search results for "GMP"
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Good Manufacturing Practices: Challenges with Compliance
…nd manufacturing organizations (CDMOs) face when adhering to current good manufacturing practices (CGMPs).
Obstacles to compliance
BioPharm: What challenges do you see in complying with FDA’…
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Gowning Practices Provide Clues to cGMP Compliance
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMPs). Quality must be built into the design of a facility to ensure that drugs are manuf…
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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, …
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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…
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Cell-free Expression Systems Pose Cell Culture Alternative
Limitations also include expensive centralized facilities, which are needed for good manufacturing practice (GMP); limited volumetric productivities due to the need to propagate cells in batch-mode bi…
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Understanding Validation and Technical Transfer, Part I
…nd Cosmetic Act, which among other provisions, authorized FDA to issue good manufacturing practice (GMP) regulations for “manufacturing, packaging, or holding of finished pharmaceuticals.” Those regu…
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Advancing Single-Use Technology Through Collaboration
A few years ago, the Disposables group within BPOG initiated a program called the Good Manufacturing Practices (GMP) Expectations Gap, which was a type of industry outreach initiative to educate stake…
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Design and Qualification of Single-Use Systems
…nt, including SUT components and systems, even when sold for use under good manufacturing practice (GMP). Suitability of design and qualification for use must be determined by the therapeutic manufac…
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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
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Risks of this type can be avoided through stringent oversight of good manufacturing practices (GMP)-compliant cleanrooms and isolator hoods as well as through the use of closed culturing systems and a…