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ABOUT GMP
WHAT IS GMP?
GUIDELINES SOURCES
USFDA TOPIC GUIDANCES
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CDER
CBER
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483 AND WARNING LETTERS
GMP GLOSSARY
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Center For Biologics Evaluation and Research (CBER) Guidances
Biotechnology Inspection Guide
(November 1991)
Compliance Program Guide - Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors
(July 2003)
Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers
(May 2002)
Draft Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
- (December 2003)
Draft Guidance for Industry: Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information
(September 2003)
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
(November 2000)
Guidance for Industry:Q8, Q9, and Q10 Questions and Answers
(May 2010)
Guideline for Quality Assurance in Blood Establishments
(July 1995)
Guide to Inspections of Infectious Disease Marker Testing Facilities
(June 1996)
Review Checklist (Blood)
(September 2006)
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MD. Saddam Nawaz
INTRO
DISCLAIMER
CONSULT EXPERTISE
PROJECT MANAGEMENT
COMMISSIONING, QUALIFICATION & VALIDATION
QUALITY MANAGEMENT SYSTEMS
REGULATORY COMPLIANCE
GMP DISCUSSION
GMP INSIGHTS
BLOG
SME VOICE
ABOUT GMP
WHAT IS GMP?
GUIDELINES SOURCES
USFDA TOPIC GUIDANCES
>
CDER
CBER
GENERICS
BIOPHARMACEUTICS
GMP INSPECTIONS
483 AND WARNING LETTERS
GMP GLOSSARY
A
B
C
D
E
F
G
H
I
K
L
M
N
O
P
Q
R
S
T
U
V
W, Y & Z