GRAM: Ensuring Quality Through Vigorous Finished Product Inspections
A Q&A with Brian Korson, director of finishing operations at Grand River Aseptic Manufacturing.
Inspections
-
Aseptic Processing | Fill/Finish | Inspections | Parenterals | QA/QC
-
Inspections | QA/QC | Regulatory Affairs
Regulatory Affairs: FDA’s Office of Compliance Issues FY 2023 Annual Report
Issued 170 warning letters and monitored 264 drug recall events during the year.Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc. 02.01.24
-
Breaking News | Facilities | GMPs/GCPs | Industry News | Inspections | QA/QC
Crystal Formulations Services Passes EU QP Audit
Crystal Pharmatech’s CDMO business unit poised for global growth.01.31.24
-
Inspections | Regulatory Affairs
FDA Inspections & Compliance Trends
A look back at 2023 and what 2024 will bring.Online Exclusives Ben Locwin , Contributing Writer 01.26.24
-
Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News | Inspections | QA/QC
FDA Finds QC Failures at Moderna's Norwood Mfg. Facility
Form 483 report obtained by Reuters notes five separate observations including equipment issues and expired items.12.18.23
-
Breaking News | cGMP Manufacture | Drug Development | Facilities | Industry News | Inspections | QA/QC
WuXi Vaccines Clears First GMP Audit
Resulted in no critical observations and will allow WuXi Vaccines to proceed with GMP manufacturing for the client's projects.12.13.23
-
Breaking News | GMPs/GCPs | Industry News | Inspections | QA/QC
Intas Pharmaceuticals Receives Another Warning Letter from FDA
Cites failure to ensure drug products manufactured at Gujarat, India plant comply with cGMP.12.01.23
-
Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Fill/Finish | GMPs/GCPs | Industry News | Inspections | QA/QC
Symbiosis Granted MHRA License Following Expansion
Adds 3,600 ft² of new space, expanding GMP operational footprint at Stirling Innovation Park in Scotland.11.21.23
-
Breaking News | cGMP Manufacture | Industry News | Inspections
Vetter’s Rankweil Site Receives Permanent Manufacturer’s Authorization
Austrian site supports manufacturing and quality control of Human Investigational Medicinal Products.11.09.23
-
cGMP Manufacture | GMPs/GCPs | Inspections
Get Ready for a New Approach to cGMP Inspections
ANDAs, Biosimilars, BLA, FDA, Generics, NDA Regulatory AffairsBob Kelly, Principal Consultant, Lachman Consultant Services, Inc. 10.27.23
-
Breaking News | Drug Development | Drug Discovery | Facilities | Industry News | Inspections
Dipharma Receives 2nd GMP Certification from Brazilian ANVISA
The Caronno Pertusella site is the second Dipharma facility to receive ANVISA certification.10.26.23
-
Breaking News | cGMP Manufacture | Drug Development | Industry News | Inspections
Quotient Sciences Concludes FDA Inspection of UK Facility
For the validation of three bioequivalence studies supporting licensing applications with the FDA.10.05.23
-
Breaking News | cGMP Manufacture | Drug Development | Facilities | Industry News | Inspections
Rentschler Biopharma’s ATMP UK Facility Receives MHRA Approval
Facility offers services from early process and analytical development through cGMP manufacturing for clinical trials.09.13.23
-
APIs | Breaking News | cGMP Manufacture | Facilities | Industry News | Inspections
Aurisco's Manufacturing Site in China Clears FDA Inspection
Site offers CDMO services and generic APIs.08.23.23
-
APIs | cGMP Manufacture | Facilities | Industry News | Inspections | QA/QC
Understanding the Causes & Impact of Drug Scarcity
The reasons behind drug shortages can range from supply and demand, manufacturing and regulatory issues, to discontinuations.Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 08.08.23
-
Inspections | QA/QC | Regulatory Affairs
FDA 2023 Inspection Roadmap: Is “Readiness” in Your Annual Objectives?
Insights from the regulatory experts at Lachman Consultants.Patrick Day, M.S., Principal Consultant, Lachman Consultants 05.25.23
-
Inspections
FDA Inspection Preparation
How to get ready for an FDA inspection – important things to know when preparing for an FDA inspection.Tamil Arasu, Principal Consultant, Lachman Consultants 04.04.23
-
GMPs/GCPs | Inspections | QA/QC | Regulatory Affairs
Pharmaceutical Recall Trends to Watch in 2023
2022 was a record-breaking year for the number of units recalled, up 114% over 2021.Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 03.31.23
-
Facilities | Inspections | Solid Dosage/Creams/Ointments
Lannett CDMO: Delivering on Expectations
The CEO of Lannett Company, Inc., talks about stepping up the visibility of its CDMO organization and showcasing the world-class capabilities supporting it.
-
Aseptic Processing | Breaking News | Facilities | Industry News | Inspections
Grand River Aseptic Manufacturing Receives Zero Observations from FDA Inspection
Aiding in the supply of Bavarian Nordic’s JYNNEOS.03.17.23
