Susan J. Schniepp

FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.

PDA’s new technical report provides a template for bio/pharma companies to follow to establish a risk-based approach to prevent drug shortages.

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Industry players and FDA evaluation possible quality metrics to improve manufacturing efficiencies and avoid drug shortages.

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

Companies can use metrics as a tool to help drive positive change and quality process improvements.

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

Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.

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

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

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.

Contract organizations must have highly organized teams and plans to accommodate today's audits.

After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.

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

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

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

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

Defining the Next Five Years.

The US Pharmacopeial Convention recently held its convention in Washington, DC.

New information improves an organization's guide to building manufacturing facilities.

We never thought implementing complex changes could become more cumbersome.

With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.

Determined to prevent further supply-chain breaches, industry takes charge, offers proposals.

Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.

A new book inspires readers to seek ways to apply NMR spectroscopy to their own purposes.

The USP public-comment process exists for a reason. Industry needs to take advantage. This article contains bonus online-exclusive material.

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.

Providing the right information upfront may ease new requirements to assess solvent levels.