Siegfried Schmitt

Parexel

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Articles

Creating a Contamination Control Strategy

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.

Principles of Equipment Qualification

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Best Practices for Developing a Third-Party Auditing SOP

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.

The Difference between Electronic Records Retention and Archiving

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

Which Batch Size for Validation and Stability Studies?

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

Remote Inspections - Lessons Learned

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

The Importance of Batch Record Reviews During Audits

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

Good Manufacturing Practice on Demand?

Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

The Remote Audit–A Tongue-in-Cheek Memo

Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.

Improve Automation, but Beware of the Pitfalls

Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.