Compendial Compliance

EMA Issues Final Opinion on Nitrosamines

July 16, 2020

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

New ASTM Standard Addresses Foreign Particles in Biomanufacturing Processes

May 01, 2020

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.

USP Offers Support for COVID-19 Drug Developers

March 19, 2020

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

Monograph Development: How to Participate; How to Harmonize

March 15, 2020

This article details the more operational aspects of monograph submissions, answering the question of how to participate.

A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials

March 15, 2020

The authors present a case study with raw materials and excipients, where a consistent, cross-functional approach is needed to ensure the appropriate selection, sourcing, testing, and filing of the materials used to manufacture bio/pharmaceutical products in a global environment, ensuring compliance with applicable compendial and regulatory requirements.

A Practical Approach to Pharmacopoeia Compliance

March 15, 2020

This series is intended to address the challenges for the industry to comply with pharmacopoeial requirements. This article returns to this important topic with a case study at the intersection of monograph development and compliance.

Pharmacopoeia Compliance: Putting it All Together; What Is on the Horizon

March 15, 2020

This article summarizes all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world. This look into what is on the horizon is important to help companies prepare for the inevitable changes and ensure the continued supply of quality medicines to patients globally.

Monograph Development: Why and When to Participate (eBook)

March 15, 2020

BioPharm International

Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.

Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon (eBook)

March 15, 2020

BioPharm International

This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.

A Practical Approach to Pharmacopoeia Compliance (eBook)

March 15, 2020

BioPharm International

This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.