Inspections

Inspections | QA/QC | Regulatory Affairs

FDA Inspection Trends Update

Insulate yourself from risk to achieve success in your FDA inspections.

Ben Locwin, Contributing Writer 05.02.22

Breaking News | Industry News | Inspections

WuXi STA Passes First EMA Drug Pre-Approval Inspection at Wuxi City Site

The Wuxi City site will start to provide commercial drug product manufacturing service of an innovative medicine for the European market.

03.03.22

Breaking News | Industry News | Inspections | QA/QC

WuXi STA Passes First U.S. FDA PAI at Waigaoqiao Site

Included manufacturing facility, equipment, labs, quality management system, tablet production, material handling, computer control systems, and data integrity.

01.04.22

Breaking News | cGMP Manufacture | GMPs/GCPs | Industry News | Inspections

Metrics Contract Services Successfully Completes ANVISA Inspection

For commercial manufacture of a branded oncology drug to be marketed in Brazil.

11.16.21

Breaking News | Facilities | Industry News | Inspections

Symbiosis Completes Successful MHRA Audit

Will expand facility at its Stirling, UK site with new storage and warehousing capability.

09.16.21

Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.

Sponsored released by Merck 06.09.21

Inspections | Validation

From Capital Builds to Staff Augmentation: Tips to Achieving Integrated CQV Strategies

An integrated CQV strategy can support current projects and ongoing operations. This webinar will cover integration strategies in several key areas.

06.09.21

Breaking News | Facilities | Industry News | Inspections

CPL Completes Successful Virtual Health Canada Audit

The CDMO created a virtual tour of its facilities in response to the pandemic.

Tim Wright, Editor, Contract Pharma 06.03.21

Breaking News | Facilities | Industry News | Inspections

Bora Pharmaceuticals Completes Health Canada Inspection

Mississauga site is the company’s first manufacturing facility in North America and is its HQ in the region.

Tim Wright, Editor, Contract Pharma 04.23.21

Breaking News | cGMP Manufacture | Industry News | Inspections

Metrics Contract Services Completes Russian Regulatory Inspection

Greenville, NC site approved to make an oncology drug to be marketed in Russia.

Tim Wright, Editor, Contract Pharma 03.09.21

Biologics, Proteins, Vaccines | Inspections | Supply Chain

Inspecting the Unexpected

Preparing quality control processes for COVID-19 vaccine candidates.

Dr. Andrea Sardella and Raffaele Pace, Stevanato Group 11.17.20

Breaking News | Industry News | Inspections

Symbiosis Completes MHRA Regulatory Inspection

Scottish CMO recorded no critical or major observations from the reinspection by the MHRA.

Contract Pharma Staff 10.13.20

Inspections

Virtual Site Audits Should Be the New Standard

Discovering the value of virtual site audits during the COVID-19 crisis.

Jeannie Metzinger, PCI Pharma Services 09.09.20

Breaking News | Facilities | Industry News | Inspections

FDA Approves Romark Facility in Puerto Rico

The facility is equipped to produce tablets, powders and other oral solid dosage forms.

Contract Pharma Staff 08.24.20

Breaking News | Facilities | Industry News | Inspections

PharmaCyte Conducts Final Audit of Mfg. Facility

Batch records in Thailand have been deemed cGMP compliant

Contract Pharma Staff 05.18.20

cGMP Manufacture | GMPs/GCPs | Inspections | Regulatory Affairs

FDA cGMP Inspections Amid COVID-19 Pandemic

Despite FDA's postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis develops.

John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao, BakerHostetler 04.22.20

Bio News | Breaking News | Industry News | Inspections

WuXi Biologics Passes EMA GMP Inspection

Suzhou site clears regulatory hurdle with not critical findings

Contract Pharma Staff 04.15.20

Breaking News | Industry News | Inspections | Regulatory Affairs

COVID-19 Update: FDA Scales Back Domestic Inspections

Temporarily postpones all domestic routine surveillance facility inspections, for-cause inspections will be evaluated and will proceed if mission-critical.

03.19.20