Quality Systems

Kieran O’Connor is Analytical Science and Technology senior chemist at SK biotek, Ireland, kieran.oconnor@sk.com. (formerly Bristol Myers Squibb)

John Wasylyk is senior principal scientist at Bristol-Myers Squibb, USA; john.wasylyk@bms.com

Bob Wethman is senior research scientist II at Bristol-Myers Squibb, USA

Ming Huang is senior research investigator I at Bristol-Myers Squibb, USA

Articles

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. 

Spectroscopy Facilitates Lean Analysis

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

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.

Effective Root Cause Determination

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

FDA Promotes Quality Standards to Reduce Shortages

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

Ensuring Quality Control in Vendor Relationships

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. 

Tris Pharma, Inc. Expands Ibuprofen Recall

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

FDA Looks to Advance Complex Generics

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. 

FDA Gives Update on NDMA Investigation

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.

FDA Publishes REMS Assessment Guidance

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

Wasdell Group’s New EU HQ Receives HPRA License

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

Quality Assurance/Quality Control