Siegfried Schmitt

Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.

The license holder should negotiate, educate, contract, and then oversee the transportation contractor, says Siegfried Schmitt, vice president, Technical at Parexel.

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

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.