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This Edition Sponsored by Gilbert Industries
Issue Highlights
- Martin Hinckley on Error Proofing
- Vaccine Manufacturing Compliance: a review of recent 483’s
- Manufacturing and Error Proofing at BIO 2008
Mistake-Proofing Pharma: A View From the Trenches
Errors are waiting to happen at many drug manufacturing facilities today. Lean and poka yoke expert Martin Hickley describes what he saw on a recent visit to one pharma plant.
Manufacturing at BIO 2008
During a Q&A session, manufacturing leaders from Genzyme, Amgen and Baxter shared their views on jidoka and error proofing within biopharm and pharma. You’ll find snippets of audio and other coverage on our BIO web page.
Vaccine Manufacturing Noncompliance - “Déjà vu
all over again?”
Yogi Berra’s infamous phrase appears to apply as patterns of noncompliance show up in recent vaccine manufacturing facility 483s. The culprits? Inadequate SOPs and root cause analysis and CAPA.
Featured Whitepaper
Use of Universal HPLC Detection for Cleaning Validations
By ESA Biosciences Inc.
Several methods and traditional cleaning solvents for manufacturing devices spiked with typical drug substances and impurities were measured using HPLC-UV and CAD detection. HPLC with CAD provides a more complete view of the data since the CAD response has less solvent interferences and does not require the presence of chromophores for detection.
How Safe is Your Supply Chain? Take Our Benchmarking Survey
Lean Pharma: Easier Said Than Done, You Say (Results of our 2008 Survey)
Side Effects by Padma Perkish (caution: only for Summer viewing after 7 PM)
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Sponsored Link
Accelerate the Commissioning Process
EnteGreat authors discuss how process history data can be used to streamline commissioning in Life Sciences.
Coming Events
6th Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device Excellence
July 28-30, Los Angeles, Calif.
3rd Annual Manufacturing Execution Systems in the Life Sciences Industry
Aug. 5-6, Philadelphia, Pa.
4th Annual Lean Six Sigma Improvement Week 2008
Sept. 16-19, Chicago, Ill.
