Quality Systems

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

Articles

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

The Importance of Batch Record Reviews During Audits

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

FDA Faces Huge Task Catching Up on Inspections

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority. 

Quality Still a Priority

Andrea Kurz is vice director, External Collaboration Europe, F. Hoffmann-La Roche Ltd.

Francisco Raya is quality assurance head, Almirall.

An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.

GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 Pandemic

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs. 

Pandemic Alters FDA Inspections and Quality Oversight

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

The Remote Audit–A Tongue-in-Cheek Memo

Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.

Verrica's Molluscum Treatment Rejected by FDA Following CMO Facility Deficiencies

US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.

Federal Court Enters Consent Decree Against Florida Compounder

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

ICMRA Sets Out Recommendations on Regulation of Future Therapies Using AI

Syntec receives warning letter where FDA finds deviations from CGMP for APIs.

Audits and Inspections