Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)

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Vendor Management for an API Manufacturer?
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4
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4,030
v9991
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Suggestions requested on handling batch record papers exposed to hormonal products
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1
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1,963
v9991
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Pallets need to be changed when raw materials are transferring from WH to MFG area?
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6
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3,423
somashekar
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Could Phase III Clinical Trials be taken without Phase I and II ?
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2
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3,045
Ajit Basrur
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Is it required to audit per 21 CFR Part 211 ?
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2
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3,022
Ronen E
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Batch Chromatography API - Blending of Batches
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4
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2,334
validationeng
Ajit Basrur
New Guideline from ICH proposed on Lifecycle Management - Q12
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2
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2,173
Ajit Basrur
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Analysis of 'Value Added' System & Process Steps - Inspection
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2
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1,761
lokeky1
Ajit Basrur
FDA Guidance Document - Expedited Programs for Serious Conditions ? Drugs & Biologics
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0
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1,731
Ajit Basrur
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Medicinal Product Registration Requirements in Brazil
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2
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3,021
Green Med
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What brand of scales do you use in pharma?
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6
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2,322
Automatic
Ajit Basrur
The British Pharmacopoeia celebrates its 150th birthday !
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2
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2,024
v9991
Ajit Basrur
FDA Loosens Pharmaceutical Regulations on 13 Companies
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1
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1,908
Ajit Basrur
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How to handle a blood stained GMP document ?
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6
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1,815
Hileen
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Setting Specification Limits for UOD (Uniformity) for Live Bacteria or Spores
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4
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2,010
v9991
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