Quality Systems

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.

FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.

Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

Today’s inspection systems catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.

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

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

FDA approved first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system.

More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.

Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.

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

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.

The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.

The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has issued a drug alert concerning a class 2 medicines recall of paracetamol tablets.

Vida International received an FDA warning letter after an inspection found quality control violations.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.

Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.