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

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Site Master File for multiple business units within same premises/facility
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1
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2,744
Marc
K
Release testing for Combination Drug-Medical Device
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0
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178
Kjenks1
P
HVAC System vs Air Handling Unit (AHU) - Differences
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1
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181
Marc
P
Fan filter unit (un-ducted to air supply) vs fan filter unit (ducted to air supply)
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1
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191
somashekar
M
Pharmaceuticals Warehouse temperature control (room temperature)
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3
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212
melancholy
P
ISO 7 Clean rooms - Are sinks, faucets, floor drains etc. allowed?
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2
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487
pcamejo
D
FDA filing guidance to add sterilization step for approved drug
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8
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722
drhkp
V
Additional Controls for processing the raw data on different computers (processing system)
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5
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339
yodon
D
Key Performance Indicators in a Pharmaceutical Company
2
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13
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30,479
v9991
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Drug packaging / filling operations
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8
Views
1,319
v9991
H
European Pharmacopoeia First Identification Requirements
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1
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1,902
v9991
A
CTD (Common Technical Document) for a Topical Preparation
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2
Views
411
Ajit Basrur
C
Informational CFR 21 Definition for Data or Raw Data
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5
Views
658
Marc
N
Generic Rework/Reprocessing Procedure
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1
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914
v9991
A
Risks related to Method Validation and Stability Studies
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2
Views
940
v9991
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