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

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Drug packaging / filling operations
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8
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1,648
v9991
H
European Pharmacopoeia First Identification Requirements
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1
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3,584
v9991
A
CTD (Common Technical Document) for a Topical Preparation
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2
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1,200
Ajit Basrur
C
Informational CFR 21 Definition for Data or Raw Data
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5
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1,572
Marc
N
Generic Rework/Reprocessing Procedure
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1
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2,845
v9991
A
Risks related to Method Validation and Stability Studies
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2
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1,434
v9991
F
Extension of a stability study for an API
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2
Views
512
fall4p
S
Should the primary drug containers be molded in ISO Class 7 clean room?
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6
Views
2,010
SGquality
J
Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
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4
Views
2,100
jmlbell
O
OTC Pharmaceuticals Labeling Submissions to the FDA
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1
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2,359
Ronen E
L
Registration of an Imported Medical Drug in Turkey
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1
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3,419
Stijloor
W
Weighing Scale used in Phamaceutical Production - Daily Verification
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8
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8,080
Metron
H
IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved
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3
Views
2,584
Ronen E
R
Contract Manufacturing - OTC (Over the Counter) vs Prescription
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2
Views
3,777
rwend07
D
Differences between (c)GMP for Drugs and Medical Devices
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3
Views
8,916
QA-Man
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