Quality Assurance/Quality Control

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.

Sample preparation-specifically, API extraction and dilution-can introduce errors. Use of best practices and automation can reduce variability.

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.

The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.

Pfizer Consumer Healthcare is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.

FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.

King Bio is recalling several of its kids and infant products due to possible microbial contamination.

FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.

Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine after FDA issues import alert affecting the active ingredient.

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.

A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.