Compendial Compliance

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.

USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.

Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.

Public health challenges have highlighted the need for agility in maintaining the quality of medicines.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.

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

Processes, people, and tools are needed to comply with the pharmacopoeia and approved drug product registrations.

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.

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.

Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.

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

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

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

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

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.

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.

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.