Quality Systems

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

Articles

A thorough investigation of all possible causes of deviations should be performed.

The Human Error Behind Human Error

How FDA, USP, and ICH have redirected industry practice.

35th Anniversary Special: The Transformation of Regulation and Global Standards

The contract provider needs to know as much as the NDA holder.

Know the Regulations

The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.

Managing the Quality Relationship for a Contractual Agreement

Why SOPs are rarely followed, often cited, and in need of follow-through.

Following our Own Instructions

What to do when your CMO changes the manufacturing equipment line.

Insider Solutions: Reporting Equipment Changes

Drug manufacturers have to be more than just "audit ready."

Insider Solutions Rule #1: Be in Compliance

Before embarking on an outsourcing relationship, it's important to be aware of FDA's expectations.

Insider Solutions: The Quality Agreement

We never thought implementing complex changes could become more cumbersome.

Managing Change Control in a Changing Environment

The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.

Standard Operating Procedures