Siegfried Schmitt

Parexel

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

Articles

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.

The Value of FDA 483s and Warning Letters

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

Computerized System Descriptions–How Hard Can It Be?

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Auditing for Good Distribution Practices

Auditing distribution suppliers provides understanding and documentation of the services performed.

Now is the Time to Update the Quality Technical Agreement

Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.