Quality Systems

FDA is examining and updating its programs for overseeing global operations and international affairs.

The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Empty and prefilled syringes must pass a range of quality control tests.

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.

The new guidance document discusses reproductive toxicity testing and labeling recommendations.

The agency approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients six to less than 17 years of age.

FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.

Managing and controlling e-records is vital for maintaining CGMP data integrity.

The agency is updating its warning requirements for eszopiclone, zaleplon, and zolpidem after reports of complex sleep behaviors.

The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.

The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.

A data exchange program between GE Healthcare and Amgen aims to improve biologics manufacturing through analysis of how raw materials affect the process.

FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.

New agency leadership is pressed to promote innovation while addressing safety and quality issues.

We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.

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

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.

The company is voluntarily recalling the product due to difficulties with the delivery system.

The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.

Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.