Quality Systems

Articles

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (eBook)

Lincoln Pharmaceuticals has received a patent, which is valid for 20 years, from the Government of India for its liquid diclofenac metered-dose rectal spray.

Lincoln Pharmaceuticals Receives Patent for Novel Diclofenac Solution

A second lawsuit has been filed by Centrient Pharmaceuticals India in the High Court of Delhi in New Delhi against Dalas Biotech for patent infringement.

Centrient Pharmaceuticals Files Second Lawsuit Against Dalas Biotech

Agnes Shanley is senior editor of Pharmaceutical Technology.

Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation. 

FDA Warning Letter to Lupin Underscores the Need for Top Management Involvement in cGMP Compliance

Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.

Evaluating Regulatory Trends Globally and Regionally

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as  inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

FDA cites repeated, fundamental cGMP issues in its warning letter to Torrent Pharmaceuticals

Glenmark Pharmaceuticals has been granted marketing approval from the Russian Ministry of Healthcare for its film-coated tablets, Montlezir, to treat seasonal and perennial allergic rhinitis.


Glenmark Gets Nod to Market Montlezir in Russia

Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars. 

What’s New in Regulations and Compliance

This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.

Regulatory/GMP Compliance, Emerging Markets