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

AnaMariaVR2
Temperature Controlled Biopharmaceutical Logistics in Central America [infographic]
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3
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2,042
Ajit Basrur
D
Quality Management Systems - Differences between ISO 13485, 21 CFR Part 820 & ICH Q10
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2
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4,350
sagai
J
Frequency of Re-Testing Working Standards (Secondary Reference Standard)
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1
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2,950
Stijloor
P
Generic Contract Manufacturing of Generic Prescription Medications
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3
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2,248
prami
A
Charge-in Components - 21 CFR Part 211 Requirements Clarification
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3
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3,655
Ajit Basrur
P
Information on FDA approval for Indian Pharma companies requested
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3
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2,383
v9991
D
Non GMP processes in a GMP facility - Can it be done?
2
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15
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6,964
Lingabathula
R
Is AQL sampling plans applicable for Bulk Pharmaceutical Manufacturing (API)?
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1
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3,596
v9991
H
OTC (Over The Counter) Wipe Product Labeling Guidelines - Question
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6
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2,884
hccrriii
A
The main functions and tasks of a Regulatory Affairs position
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4
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2,126
anaidagf
Ajit Basrur
FDA Guidance - Heparin for Drug and Medical Device
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1
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2,221
Stijloor
O
Process Validation (Blend Uniformity/Content Uniformity)
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4
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11,441
v9991
S
New FDA Guidance document released for Promotional Material, Labeling, etc
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1
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1,886
MIREGMGR
D
Pharmaceutical Company Quality Manual
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6
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15,142
M Tanveer
AnaMariaVR2
GMP News: New Version of ISO 19011 on Auditing published
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2
Views
1,754
AnaMariaVR2
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