Inspections
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cGMP Manufacture | Facilities | Industry News | Inspections
Umicore API Facility Passes cGMP Audit
The plant manufactures four oncology APIs produced for global markets according to the latest international guideline06.20.18
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Inspections | Regulatory Affairs
PAI Readiness – A Journey, not an Event
A look at what you need to do to get ready for a pre-approval inspectionDr. Walter Matzmorr, Tunnell Consulting 06.12.18
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cGMP Manufacture | Industry News | Inspections
Pii Gets Positive Inspection News from FDA and MHRA
Previously restricted GMP Certificate withdrawn based on recent inspections by the FDA06.11.18
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cGMP Manufacture | Industry News | Inspections
Samsung BioLogics Receives Additional FDA Approval
Gains third approval for Plant 2 in 26 months05.24.18
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Bio News | Industry News | Inspections
Cytovance Biologics Completes FDA Inspection
The successful five-day process focused on quality systems, facilities, maintenance programs and manufacturing05.09.18
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Breaking News | Industry News | Inspections
WuXi STA Changzhou Site Passes First U.S. FDA Inspection
The integrated R&D and manufacturing facility is expecting more products to go into commercial production post approval05.08.18
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Inspections
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Breaking News | Facilities | Industry News | Inspections | Methods Development
Vetter Wins 2018 ISPE Facility of the Year Award
For the Center for Visual Inspection and Logistics03.21.18
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Industry News | Inspections | Regulatory Affairs
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Bio News | Breaking News | Drug Delivery | Industry News | Inspections | Regulatory Affairs
PharMEDium Services Expands Recall
The company has not received any reports of adverse events related to the products but is issuing this recall out of caution01.11.18
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | Inspections | Validation
VIDEO: Samsung BioLogics Receives EMA Approval for its Second Plant
Licensed by EMA for its second plant only two months after FDA approval12.13.17
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APIs | Chemistry | Inspections
Novasep
Novasep provides a full range of CMO and development services for the Life Science industries with a wide range of flexible assets on multiple sites. We are a world leader in HPAPIs (cytotoxics and ADC payloads), viral vectors for gene therapy &…Emilie Duchene, Marketing Manager 12.04.17
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Inspections
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Breaking News | Cytotoxics and High Potency Manufacturing | Drug Development | Facilities | Industry News | Inspections | Solid Dosage/Creams/Ointments
Almac Passes MHRA Inspection at Charnwood Facilities
Can develop, make and pack non-potent and potent, solid orals for clinical trials and commercial supply10.23.17
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Breaking News | Industry News | Inspections
CordenPharma Latina US-FDA Warning Letter Closed
Closeout date was August 15 for the Italy facility08.24.17
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Industry News | Inspections
Valeant's Tampa Facility Receives FDA VAI Classification
Following collaboration with FDA, issues related to a cGMP inspection are being resolved08.17.17
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Breaking News | Facilities | Industry News | Inspections
Aerie Pharma’s CMO Receives FDA CRL
Was issued in response to CGMP inspection at Tampa facility08.10.17
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Industry News | Inspections
Envigo Site Recertified to New ISO Standard
ISO9001:2015 revision has re-focused on performance by combining the process approach with risk-based thinking07.28.17
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Industry News | Inspections
Cytovance Completes FDA Inspection at Oklahoma City Facilities
Takes action to address facility updates and improvements07.24.17
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cGMP Manufacture | Industry News | Inspections
QS Pharma Gains EMA Approval for Commercial Manufacture
Boothwyn, PA facility to manufacture certain medicinal products for commercial use in Europe06.27.17
