Audits and Inspections

The Importance of Appropriate Supplier Oversight

November 02, 2024

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel.

Keeping Audit and Inspection Programs Current

September 02, 2024

Updating your audits and inspections program ensures inspection preparedness, says Siegfried Schmitt, vice president, Technical at Parexel.

Post-Warning Letter Interaction with FDA

July 02, 2024

Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA’s Office of Pharmaceutical Quality Reports on 2023 Quality Assessments

April 04, 2024

The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.

Are You Ready for Inspection?

January 02, 2024

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.

Consent Decree Entered Against Pharmasol

December 15, 2023

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

Using a Third Party to Perform Audits

November 02, 2023

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

FDA Provides Guidance on Remote Facility Evaluations

November 01, 2023

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

FDA Inspections Face Overhaul

September 28, 2023

The agency will be reorganizing field force and compliance functions.

Clearing Up Confusion in Inspection Terminology

September 02, 2023

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