Quality Assurance/Quality Control

Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

September 01, 2018

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

Ensuring Consistency in Content Uniformity Testing

September 01, 2018

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

PDA’s New Technical Report Highlights Data Integrity Management System for Pharma Labs

August 29, 2018

Pharmaceutical Technology's In the Lab eNewsletter

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.

Quality Failures at Foreign Manufacturers Prompt Warnings and Recalls

August 28, 2018

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

Accord Healthcare Inc. Recalls Hydrochlorothiazide Tablets USP 12.5 Mg

August 28, 2018

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

Pfizer Recalls Children’s Advil

August 28, 2018

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.

Data Integrity Violations Found at Japanese Facility

August 24, 2018

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 Recalls Products Due to Microbial Contamination

August 22, 2018

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

Repeat Quality Deviations Found at India Facility

August 16, 2018

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

Import Alert Spurs Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP)

August 13, 2018

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