Title 21, Code of Federal Regulations, Part 11. Part 11 established the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes regulated by the FDA. See Code of Federal Regulations.
Glossary
21 CFR Part 11
02.27.12
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Drug Development | Laboratory Testing
Eliminating Endotoxins – Reagent Quality Testing for Cell and Gene Therapies
The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.Garrett Perry, Technical Services Specialists at Teknova
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Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids
Recro Gainesville Expands Mfg. Capabilities
Installs new tableting equipment and grows development team
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Diverse Products And Technologies Delivered
For Avanir, Breath Powered Meets Pharma Tech's Breadth of ServicesReleased by: Pharma Tech Industries
