Search results for "pharmacopeia"
Article
Establishing Acceptance Criteria for Analytical Methods
This concept has been well established for many years in chemical, automotive, and semiconductor industries and is recommended in the United States Pharmacopeia (USP) and (4, 5). Effectively the que…
Article
Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The United States Pharmacopeia (USP) reference standard of folic acid was purchased from Sigma-Aldrich (Saint Louis, MO) (catalog number 1286005).
Osmolality method
Osmolality was performed es…
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Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
USP Stresses Pharmacopeial Standards at CPhI China
“To address growing demands, USP is committed to helping these companies meet pharmacopeial standards, provide training and certification services to help them comply, and also guide them to contribut…
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What’s In a Name? For Biosimilars, A Lot
It has been reported that FDA determined that the United States Pharmacopeial Convention’s (USP’s) monograph for filgrastim does not apply to the first-ever approved biosimilar product, Zarxio (filgra…
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Ensuring the Quality of Biologicals
Pharmacopeial standards for biologicals
Biologicals are large and often highly complex molecules. The Ph. Eur. has established general monographs that cover common quality attributes and that are …
Article
USP Publishes Monoclonal Antibody Guidelines
Because of structural similarities between antibodies of the same class, the United States Pharmacopeial Convention’s (USP) expert panel decided to focus its efforts in developing standards for mAbs o…
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Quality by Design and Extractable and Leachable Testing
Examples include the gravimetric leachable criteria for nonvolatile residues, residue on ignition, heavy metals, and buffering capacity outlined in United States Pharmacopeia (USP) Containers—Plastic…
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Global Expansion Shapes Drug Oversight
Global expansion has been a prominent theme at the United States Pharmacopeia (USP), which now has offices and laboratories in India, China, and Brazil to provide local manufacturers with access to re…