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BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.

BPTF Calls for Changes to GDUFA

USP announces an implementation date of Jan. 1, 2018 for General Chapters  Elemental Impurities-Limits and  Elemental Contaminants in Dietary Supplements.

USP Establishes Elemental Impurities Implementation Dates

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

NSF International Publishes National Standard for Excipient Good Manufacturing Practices

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

EMA Sets Elemental Impurities Implementation Dates

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

USP Elemental Impurities Implementation Set for January 2018

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Chinese API and Drug Manufacturer Issued Warning Letter

Shimadzu?s Nexera MP UHPLC Front End system for LC/MS is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes.

The Nexera MP UHPLC for LC/MS analysis in drug detection processes

Carmelo Rosa is chair of the PIC/S API Expert Circle and director, Division of International Drug Quality, US FDA.

Paula R. Katz, acting branch chief for Regulatory Policy and Collaboration, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

Alicia Mozzachio, branch chief, Division of International Drug Quality, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Deficiencies Found in API Inspections

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS).

Regulatory and QA/QC Focus Elemental Impurity Analysis

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

Drug Substance Analysis