Standard Operating Procedures

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

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.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices.

The agency cites Apotex’s Bangalore facility with quality system failures.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to handle staff challenges to regulation requirements

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses the requirements for good distribution practices.

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

A drug sponsor?s responsibility does not end when a task is outsourced.

Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how human error can be mitigated in pharmaceutical manufacturing.

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

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

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.

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.

We never thought implementing complex changes could become more cumbersome.

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.

The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.

This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.

USP's proposed General Chapter 1226 "Verification of Compendial Procedures" aims to provide guidance about the verification process.

The authors dispel common misinterpretations of the United States Pharmacopeia.