Inspections

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

Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs

COVID-19 Update: FDA Foreign Inspections

To postpone most foreign inspections through April, effective immediately

03.10.20

Breaking News | Industry News | Inspections

MedPharm Completes FDA Inspection

No 483s issued at its Durham, NC CoE

03.05.20

Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs

FDA Provides Update on Activities Related to Coronavirus

Says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world

02.25.20

Breaking News | Industry News | Inspections

Avara Liscate Passes FDA Inspection

Appoints new manufacturing director to leadership team

02.04.20

Breaking News | Industry News | Inspections

LSNE-León Successfully Completes PAI

Can now support commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation

01.21.20

Breaking News | Facilities | Industry News | Inspections

Metrics Completes Japanese Regulatory Inspection

Marks the first international inspection of the company’s new 126,000-square-foot commercial manufacturing facility constructed in 2018.

11.18.19

Breaking News | Facilities | Industry News | Inspections

WuXi STA’s Jinshan Facility Passes EMA Inspection

Five-day inspection covered 11 products approved by EMA in recent years.

10.28.19

Breaking News | GMPs/GCPs | Industry News | Inspections

ASIT biotech Receives GMP Certification

Site in Liège, Belgium to manufacture in-house the active pharmaceutical ingredient of its leading product for grass pollen allergies

10.07.19

Breaking News | Industry News | Inspections | Regulatory Affairs

Almac Completes Three Regulatory Inspections

Inspections at Charnwood, Craigavon, and Audubon sites successful

09.27.19

Bio News | Breaking News | Industry News | Inspections

3P Biopharmaceuticals Receives FDA approval

FDA classified 3P facilities as acceptable for manufacture of target molecule, and appropriate for commercialization in the US once product is authorized

09.18.19