Standard Operating Procedures

Compliance with US and EU Internal Audit Requirements

July 02, 2015

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

Managing Supplier Data Collection

March 02, 2015

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

FDA Issues Warning Letter to India Facility

February 23, 2015

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

Where is it Written?

January 02, 2015

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

Good Distribution Practices: Who is Responsible?

December 02, 2014

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

PTSM: Pharmaceutical Technology Sourcing and Management

Moving from Corrective to Preventive Actions

December 01, 2014

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

PTSM: Pharmaceutical Technology Sourcing and Management

Key Considerations for Quality-Technical Agreements

May 30, 2014

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

Quality-Technical Agreements

May 02, 2014

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

The Human Factor

February 02, 2014

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

The Elements of Training

September 02, 2013

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