Compliance Notes

USP Offers Support for COVID-19 Drug Developers

March 19, 2020

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

Integrating Technology Transfer and Facilities Startup for Biologics

April 01, 2016

Careful planning, adequate staffing levels, and experienced project managers can help avoid pitfalls of transferring processes from one facility to another.

Good Documentation Practice: Saving Data for the Long Term

November 01, 2015

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

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.

How to Stay Abreast of Shifting Regulations and Remain Compliant

May 02, 2015

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

Quality Agreements for Contract Manufacturers

September 01, 2014

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

Operational Excellence: More Than Just Process Improvement

October 01, 2013

By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.

State of Quality and Compliance in the Biopharmaceutical Industry

April 01, 2013

Have FDA initiatives improved manufacturing quality?

Connecting QbD, Knowledge Management, and Supplier Quality Management

November 01, 2012

Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.

Reduce Analytical Testing and Costs Without Compromising Compliance

July 01, 2012

Unnecessary analytical testing can lead to unnecessary costs.