Quality Systems

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.

The agency is reviewing Xeljanz (tofacitinib) because of the risk of blood clots in the lungs.

The company is recalling the lots because of possible peanut flour contamination.

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.