Inspections
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Breaking News | Facilities | Industry News | Inspections
Flamma Completes Successful CFDA Inspection
Milestone is part of the Flamma 2020 Plan to bring improvement across the CDMO’s network of manufacturing sites03.21.19
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Breaking News | Facilities | Industry News | Inspections
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Breaking News | cGMP Manufacture | Industry News | Inspections
WuXi AppTec Testing Facilities Complete Inspections
Sites in Suzhou and Shanghai receive CNAS and OECD GLP accreditation03.11.19
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Inspections | Serialization | Vials
Secondary Packaging
Reed-Lane is a full-service contract packager capable of taking your products straight through the final packaging process. We offer a variety of secondary packaging capabilities, featuring final quality inspections serving as your products’…
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Chemistry | Inspections | Microbiology | Process Validation | Regulatory Affairs | Supply Chain | Validation
Support Services
Support Services - our commitment to quality Jubilant HollisterStier provides a full-range of support and services to streamline the manufacturing process. We offer on-site assistance from process qualifications through product release.…
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News | Inspections
WuXi Biologics Completes EMA GMP Inspection
Becomes the first biologics company in China to do so02.22.19
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Breaking News | Industry News | Information Technology | Inspections | QA/QC | Regulatory Affairs | Validation
Top Global Pharma Company to Implement ValGenesis' VLMS
Paperless validation system aims to harmonize and standardize the validation process across all its global sites02.12.19
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Inspections
Upperton Pharma’s Nottingham Site Passes MHRA Inspection
Gains licenses for manufacture, downstream processing into capsules and tablets, as well as spray dried formulations of biotherapeutics and small molecule APIs01.16.19
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Breaking News | Industry News | Inspections
Akorn Receives FDA Warning Letter
Akorn is working collaboratively with the FDA to resolve all issues related to an inspection of its Decatur, IL manufacturing facility01.09.19
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APIs | Breaking News | Facilities | Industry News | Inspections
CordenPharma Completes SafeBridge Recertification
Potent Compound Recertification Audit was conducted at Colorado site11.20.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
GRAM Completes Successful FDA Inspection
Following eight day inspection, GRAM was found to be in compliance with cGMP, with no Form 483 observations issued11.09.18
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Bio News | Industry News | Inspections
Avance Completes Successful FDA Inspection
Houston facility was successfully inspected by the U.S. FDA on October 1 through October 4, 2018.10.31.18
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Breaking News | Industry News | Inspections
Almac Completes HPRA Inspection at its European Campus
Can now support analysis of commercial drug product and provide flexible secondary labelling and packaging solutions10.26.18
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APIs | Breaking News | Cytotoxics and High Potency Manufacturing | Industry News | Inspections | QA/QC | Regulatory Affairs
Recipharm Audit Results in Licence Restriction
Five non-critical highly potent products from the Ashton-u-Lyne, UK site suspended due to potential cross contamination risk10.25.18
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Bio News | cGMP Manufacture | Industry News | Inspections | Scale-up/Technology Transfer
SEA Vision Launches HarleNir
Near Infrared Hyperspectral vision system can inspect an entire batch on the manufacturing line in a fully automated fashion10.22.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Almac Completes Successful HSA Inspection
Underwent regulatory inspection by the Health Sciences Authority of its facility in Singapore10.22.18
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APIs | Breaking News | Facilities | Industry News | Inspections
Asymchem Passes FDA Inspection at API Mfg. Site
Reports successful FDA inspection of Tianjin 2 development and commercial manufacturing facility with no Form 483 issued09.14.18
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Bio News | Breaking News | Facilities | Industry News | Inspections
ADMA Biologics Reports Updated Compliance Status
FDA inspection database confirms VAI status of Boca Raton, FL facility09.05.18
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APIs | Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Novasep Announces Successful FDA Inspection
At its API development and manufacturing site in Chasse-sur-Rhône, France08.27.18
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Facilities | Inspections | QA/QC | Regulatory Affairs
Are Indian Generic Firms Improving Compliance?
Indian firms take the generics battle to U.S. turf.Online Exclusives S. Harachand, Contributing Editor 08.09.18
