Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Computer Validation Confirms Evidence

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Digitalization of QbD Risk Assessments

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

EMA and FDA Answer Questions About Breakthrough Therapies

December 21, 2023

The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.

EMA Publishes Guide for Use of AI in Medicine Regulation

December 18, 2023

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

Compounding Overview: Primary Considerations in the Workplace

December 18, 2023

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs

December 15, 2023

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

Consent Decree Entered Against Pharmasol

December 15, 2023

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

December 14, 2023

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

FDA Announces Advisory Committee for Genetic Metabolic Disease Treatments

December 13, 2023

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

Sanofi to Terminate Rare Disease Drug Licensing Agreement with Maze Therapeutics in Wake of FTC’s Challenge

December 13, 2023

Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.

List of Critical Medicines Published in EU

December 13, 2023

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

InvaGen Pharmaceuticals Recalls Vigabatrin for Oral Solution, USP 500 mg

December 11, 2023

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.