Siegfried Schmitt

The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

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

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

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.

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

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

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.

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

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