USP and Chinese Pharmacopeia Extend Partnership
The United States Pharmacopeial Convention (USP) and the Chinese Pharmacopoeial Commission (ChP) have renewed an agreement to work together to collaborate to strengthen pharmacopeial standards as a...
View ArticleICH Discusses Global Drug Development and Biopharma Guidelines
The International Council for Harmonization (ICH) plans for new harmonization of biopharmaceutical classification system-based biowaivers and bioanalytical method validation as well as continued...
View ArticleWhat s In a Name? For Biosimilars, A Lot
There is still some uncertainty surrounding whether a biosimilar will share the same compendial identity or biological product monograph as its reference product. Pharmaceutical Technology spoke to...
View ArticleUSP Publishes Monoclonal Antibody Guidelines
As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expanded in healthcare, raising questions and presenting crucial...
View ArticleUSP Elemental Impurities Implementation Set for January 2018
The US Pharmacopeial Convention (USP) has announced plans to establish Jan. 1, 2018 as the new date of applicability of General Chapters Elemental Impurities Limits and Elemental Contaminants in...
View ArticleStandards Organizations Update
Worldwide standards organizations implemented changes to pharmacopeial standards, published new guidelines, and continued to work toward harmonization as 2014 drew to a close. The following are a few...
View ArticleSecuring the Supply Chain
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View ArticleFinished Product Monographs in the European Pharmacopoeia
The European Pharmacopoeia (Ph.Eur.) , which is celebrating its 50th anniversary in 2014, has a worldwide reputation for its monographs on APIs and excipients. Owing to its close collaboration with...
View ArticleControl Strategies for Synthetic Therapeutic Peptide APIs Part I: Analytical...
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View ArticleLarge Industry Cross-Section Contributes to PDA Quality Metrics Recommendations
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View ArticleDeficiencies Found in API Inspections
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View ArticleControl of Elemental Impurities
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View ArticleUSP Seeks Input on Standards for Plastic Packaging Systems
Prefilled syringes, parenteral drugs, and many therapeutic biologics delivered through infusions are contained in plastic packaging systems. Packaging systems must protect and be compatible with the...
View ArticleUSP Partners Globally for 21st-Century Medicines
Pharmaceutical Technology USP focuses on building worldwide partnerships in standards-setting activities. USP Partner
View ArticleThe Need for Pharmacopeial Harmonization
Pharmaceutical Technology In the context of international trade, the need to develop global quality standards for medicines is increasing.
View ArticleFixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards
Pharmaceutical Technology This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This art
View ArticleMoisture Permeation of Pharmaceutical Packaging
A key factor in maintaining the quality of a pharmaceutical product throughout its shelf life is the integrity of its packaging. Preventing moisture from permeating through the packaging is an...
View ArticleConforming to the IPEC CoA Guide
Pharmaceutical Technology Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.
View ArticleModernization of USP Standards
Pharmaceutical Technology The US Pharmacopeial Convention contiues to make modernization of standards a top priority in 2013.
View ArticleStandards-Setting Activities on Impurities
1 2 Next As pharmaceutical products have evolved over the decades, so have processes for their manufacture and analytical techniques for understanding their composition. For every medicine taken by a...
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