Quality Systems

Anthony Warchut is vice-president, Technical at PAREXEL Consulting.

Keith Chidwick is vice-president, Technical at PAREXEL Consulting.

Articles

Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.

Want Faster and Cheaper with Higher Quality? Get it Right the First Time

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

GMP Issues Derail a New Drug Approval for the Second Time

Pawel Drapala, PhD, is an associate director, development and operations at Tesaro, Inc.

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

Deviation Investigation Format and Content: A Guide for Inspection Success

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

Process Validation Evolution—The Lifecycle Approach

Sean Milmo is a freelance writer based in Essex, UK.

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

A Question of Quality

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


Hospira Sterility Problems Cause Another Recall

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.


Compounding Facility Cited for Lack of Sterile Conditions

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

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Ensure Quality in a Contract Test Laboratory

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.

Using Process Validation to Ensure Quality

Catherine Shaffer is a contributing writer to BioPharm International, cathshaffer@gmail.com.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

Quality Assurance/Quality Control