Quality Systems

This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.

Russell Madsen, president, The Williamsburg Group, and member of the Pharmaceutical Technology editorial advisory board, shares his thoughts on technology innovations and regulatory implications.

Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.

Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.

Cheaper drugs are good for consumers, but cost restrictions limit drug company incentives to modernize facilities.

Regulations and business changes have altered Big Pharma’s place in the industry.

Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.

The agency determined additional guidance was needed to reduce regulatory compliance burden.

The agency announced a plan to eliminate its existing orphan designation request backlog.

The directorate highlights its 2016 achievements.

The agency announced it is taking steps to increase competition within the prescription drug market.

The agency sent a warning letter to Raritan Pharmaceuticals, Inc. after an inspection found quality testing and misbranding violations.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.

The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.

The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.

The company recalled a variety of products due to the potential of microbial contamination.

Congressional measures lack the support to move forward.

A consent decree of permanent injunction was entered between the United States and the two companies due to unapproved, mislabeled, and adulterated drugs.

The company has extended its voluntarily recall of one lot of paliperidone extended-release tablets to the consumer level due to dissolution test failure.