Health Canada GMP Inspectors Turning to Video, Teleconferencing; Three Case Studies Presented

Recent changes in Health Canada’s GMP inspection function include a reorganization and renaming from

Flawed Process Validation, Ineffective Quality Unit Cited in Warning Letter

At the International GMP Conference held virtually in early March 2021 co-sponsored by the University

Incorrect Specifications, Process Validation Issues at CMO Lead to Adverse Events, Recall

At the International GMP Conference held virtually in early March 2021 co-sponsored by the University of

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.

OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.

FDA Warning Letters: 11/22/2020 & 12/1/2020

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter

Part II: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

[Editor's Note: This is Part II of an analysis of the FY2019 UK MHRA GMP deficiencies by Redica Systems

Part I: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

[Editor's Note: Below is Part I of an analysis of the U.K. MHRA GMP deficiencies for 2019. Part II will

FDA FY2020 Drug Inspection Observations and Trends

A comprehensive GMP intelligence program includes monitoring health authority enforcement actions. 

Webinar – Panel Discussion Remote Audits

Webinar – Leadership SOS – Turning Failure into Success

Webinar – How to Build and Implement a QMS for Small Pharma and Biotech Firms

Report – Analysis of 2019 UK MHRA GMP Inspection Findings

APAC Trend Report

Report – FDA FY2020 Drug Observations and Trends

Assessment – Investigator Snapshot

Assessment – Peer Benchmark Report

Assessment – CFR Trend Report