Inside USP: International Dialogue on Biologics Standards
USP promotes horizontal standards for biologics' quality attributes.Date: Tue, 2011-08-02 (All day)Publish Start Date: Tue, 2011-08-02 (All day)Article sort author:...
View ArticleInside ICH: Quality Implementation and Harmonization Continue
A summary of the latest steering committee and expert working groups' meeting.Date: Fri, 2011-09-02 (All day)Publish Start Date: Fri, 2011-09-02 (All day)Article sort author:...
View ArticleInside IPEC: IPEC Tackles Monographs, Impurities, Particles, and More
As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.Date: Fri, 2011-12-02 (All day)Publish Start Date: Fri, 2011-12-02 (All...
View ArticleInside ICH: ICH Implementation Support
ICH Q8, Q9, and Q10 support and implications for the future.Date: Thu, 2012-02-02 (All day)Publish Start Date: Thu, 2012-02-02 (All day)Article sort author:...
View ArticleInside USP: A Holistic Approach to Supply-Chain Integrity
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.Date: Fri, 2012-03-02 (All day)Publish Start Date: Fri, 2012-03-02 (All day)Article sort author:...
View ArticleInside PIC/S: Top GMP Deficiencies
Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.Date: Mon, 2012-04-02 (All day)Publish Start Date: Mon, 2012-04-02 (All day)Article sort author:...
View ArticleInside USP: US Pharmacopeia Proposes New Standard on Glass Quality
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.Date: Sat, 2012-06-02 (All day)Publish Start Date: Sat, 2012-06-02 (All day)Article sort author:...
View ArticleStandards-Setting Activities on Impurities
USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.Date: Wed, 2013-01-02 (All...
View ArticleModernization of USP Standards
The US Pharmacopeial Convention contiues to make modernization of standards a top priority in 2013.Date: Sat, 2013-02-02 (All day)Publish Start Date: Thu, 2013-02-07 (All day)Article sort author:...
View ArticleConforming to the IPEC CoA Guide
Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.Date: Sat, 2013-03-02 (All day)Publish Start Date: Mon,...
View ArticleFixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards
This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive...
View ArticleMoisture Permeation of Pharmaceutical Packaging
USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.Date: Tue, 2013-04-02 (All day)Publish Start Date: Tue, 2013-04-02 (All day)Article sort author:...
View ArticleThe Need for Pharmacopeial Harmonization
In the context of international trade, the need to develop global quality standards for medicines is increasing.Date: Tue, 2013-04-02 (All day)Publish Start Date: Tue, 2013-04-02 (All day)Article sort...
View ArticleUSP Partners Globally for 21st-Century Medicines
USP focuses on building worldwide partnerships in standards-setting activities.Date: Tue, 2013-07-02 (All day)Publish Start Date: Wed, 2013-07-03 (All day)Article sort author:...
View ArticleControl of Elemental Impurities
The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.Date: Sat, 2013-11-02 (All day)Publish Start Date: Sat, 2013-11-02 (All day)Article sort author:...
View ArticleDeficiencies Found in API Inspections
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.Date: Mon, 2013-12-02 (All day)Publish...
View ArticleLarge Industry Cross-Section Contributes to PDA Quality Metrics Recommendations
PDA works with FDA to create pharmaceutical quality metrics.Date: Sun, 2014-02-02 (All day)Publish Start Date: Sun, 2014-02-02 (All day)Article sort author:...
View ArticleSecuring the Supply Chain
Regulators and industry leaders take on the task of securing the drug supply chain.Date: Wed, 2014-07-02 (All day)Publish Start Date: Wed, 2014-07-02 (All day)Article sort author:...
View ArticleStandards Organizations Update
In late 2014, standards organizations continued to work towards harmonization and securing drug safety.Date: Fri, 2015-01-02 (All day)Article sort author:...
View ArticleUSP Publishes Monoclonal Antibody Guidelines
A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.Date: Mon, 2015-03-02 (All day)Article sort author:...
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