Quality Assurance/Quality Control

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.

Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.

Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.

Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.

Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.

The company announced it was named the winner of the Analysis, Testing, and Quality Control category.

The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.

In a statement, Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, highlighted the agency’s efforts to enhance the efficiency of postmarket drug safety surveillance.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

An effective quality control unit is independent from manufacturing and ensures current standards are followed.

FDA readies more efficient oversight processes while advancing collaboration with Europe.

It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.

The company is recalling Alprazolam Tablets, USP C-IV 0.5 mg because of potential presence of foreign substance.

Dr. Reddy’s, Sanofi, and Perrigo Company issued voluntary recalls of ranitidine in October 2019 because of N-Nitrosodimethylamine contamination.

The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.

The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.