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

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Recall Process for Pharmaceuticals - Example wanted
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9
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6,770
amodra
AnaMariaVR2
Nanodrop Spectrophotometer
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3
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6,068
12stones
AnaMariaVR2
Laboratory Equipment Quality System - Calibration, Maintenance and Inspection
2
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10
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5,889
AnaMariaVR2
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Ventilation equipment- Are there any FDA or pharmaceutical industry requirements
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1
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1,904
PotentCompoundSafety
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Concepts and Industry Practices of Measurement-Metrics-QA (Pharma/Device Industry)
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2
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2,743
v9991
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GMP guideline for Manufacturing of Inhaled Dosage Forms
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2
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3,191
shraddha13
S
Details to be covered under Equipment Qualification for Pharmaceutical Products?
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1
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3,246
harry
N
Change Control for Laboratory Working Standards - We use in-house reference standards
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3
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3,971
Ajit Basrur
jkuil
Clean Room Class for Aseptic Preparation
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4
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5,040
Ajit Basrur
Wes Bucey
Recalls - No injuries - Just sloppy processes?
2
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16
Views
4,462
liamkeene
R
Microbiological Cleaning Validation of Tablet Press Machine
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6
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6,403
Ajit Basrur
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Jackets for NDA (New Drug Applications) submissions - FDA Guidance
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2
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2,470
Tuckee
C
Selecting Consultants for getting drug approval in USFDA
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1
Views
1,875
Stijloor
Ajit Basrur
Teva recalls drug following Jackson death probe
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1
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1,913
HellenK
Ajit Basrur
Relationship between Blend Uniformity and Content Uniformity
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2
Views
9,150
Reiko Shiratori
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