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

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Pre-dispensed API material received in predetermined quantities & given to production
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1
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2,681
Stijloor
S
Does a Research facility require DEA registration ?
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1
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2,850
Stijloor
R
Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem?
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2
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3,391
v9991
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Can I view listed drug products on FDA website similar to listed medical devices?
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4
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3,036
v9991
K
Vendor Management for an API Manufacturer?
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4
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4,155
v9991
C
Suggestions requested on handling batch record papers exposed to hormonal products
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1
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2,018
v9991
E
Pallets need to be changed when raw materials are transferring from WH to MFG area?
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6
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3,499
somashekar
S
Could Phase III Clinical Trials be taken without Phase I and II ?
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2
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3,096
Ajit Basrur
P
Is it required to audit per 21 CFR Part 211 ?
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2
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3,236
Ronen E
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Batch Chromatography API - Blending of Batches
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4
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2,393
validationeng
Ajit Basrur
New Guideline from ICH proposed on Lifecycle Management - Q12
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2
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2,236
Ajit Basrur
V
Analysis of 'Value Added' System & Process Steps - Inspection
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2
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1,834
lokeky1
Ajit Basrur
FDA Guidance Document - Expedited Programs for Serious Conditions ? Drugs & Biologics
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0
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1,844
Ajit Basrur
F
Medicinal Product Registration Requirements in Brazil
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2
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3,071
Green Med
N
What brand of scales do you use in pharma?
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6
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2,387
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