Quality Assurance/Quality Control

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.

FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.

A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.

The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.

The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.

The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.

The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Policies emphasize the importance of ensuring data integrity in the United States and abroad.

A look at some best practices to ensure that quality control is maintained in the client–vendor relationship.

The company is recalling three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL because of a higher concentration of ibuprofen.

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs.

The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.

The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.

The Wasdell Group has been granted a Health Products Regulatory Authority (HPRA) license for its new European headquarters, based in Dundalk, Ireland.

The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.

The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.

Sun Pharmaceutical Industries, Inc. is recalling lots of Vecuronium Bromide for Injection because of glass particulates.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.