Quality Assurance/Quality Control

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Automated, electronic systems for raw materials tracking improve efficiency and prevent mistakes in biopharma manufacturing.

Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.

A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

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

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

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

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.

FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.

The company is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the hospital/retail level because of a lack of confirmation of sterilization for some vials from this lot.

FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.

FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.

A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.

EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.

At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.