Compendial Compliance

The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.

The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.

The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.

The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.