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
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CDER
CBER
GENERICS
BIOPHARMACEUTICS
GMP INSPECTIONS
483 AND WARNING LETTERS
GMP GLOSSARY
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Center For Drug Evaluation (CDER) and Research Guidelines
Active Pharmaceutical Ingredient (API) Process Inspection; Compliance Program Guidance Manual
Bar Code Label Requirements--Questions and Answers
- Final(October 2006)
CGMP for Phase 1 Investigational Drugs
(July 2008)
Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information
- Draft (September 2003)
Compliance Program Guidance Manual For FDA Staff: Drug Manufacturing Inspections
(February 2002)
Compressed Medical Gases
- Final (February 1989)
Computerized Systems Used in Clinical Investigations
- Final (May 2007)
Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers
(May 2002)
Current Good Manufacturing Practice for Combination Products
- Draft (September 2004)
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
- Final (June 1987)
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide
- Draft (May 2005)
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
- Final (January 2006)
Process Validation: General Principles and Practices
(January 2011)
Glossary of Computerized Systems and Software Development Terminology
(August 1995)
Good Laboratory Practice Regulations Questions and Answers
Final (March 1998)
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory
- Final (April 2001)
Guidance for Industry:Q8, Q9, and Q10 Questions and Answers
(May 2010)
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24)
Draft released for comment (August 2006)
Guide to Inspections of Dosage Form Drug Manufacturers - CGMP's
(October 1993)
Guide to Inspections of Foreign Pharmaceutical Manufacturers
(May 1996)
Guide to Inspections of High Purity Water Systems
(July 1993)
Guide to Inspections of Lyophilization of Parenterals
(July 1993)
Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories
(July 1993)
Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development & Validation
(January 1994)
Guide to Inspections of Oral Solutions and Suspensions
(August 1994)
Guide to Inspections of Pharmaceutical Quality Control Laboratories
(July 1993)
Guide to Inspections of Sterile Drug Substance Manufacturers
(July 1994)
Guide to Inspections of Topical Drug Products
(July 1994)
Guide to Inspections of Validation of Cleaning Processes
(July 1993)
ICH Q7A - Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Final Guidance
(August 2001)
Investigating Out-of-Specification Test Results for Pharmaceutical Production
- Final (October 2006)
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients
- Draft (April 1998)
Marketed Unapproved Drugs -- Compliance Policy Guide
- Final (June 2006)
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment
- Final (March 1998)
Part 11, Electronic Records; Electronic Signatures - Scope and Application
- Final (September 2003)
PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
- Final (September 2004)
PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399 KB)
(December 2009)
Pharmacy Compounding -- Compliance Policy Guide- Final
(May 2002)
Possible Dioxin/PCB Contamination of Drug and Biological Products
- Final (August 1999)
Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment
- Draft (November 2003)
Revised Attachments
Preparation of Investigational New Drug Products (Human and Animal)
- Final (November 1992)
Prescription Drug Marketing Act - Donation of Prescription Drug Samples to Free Clinics
- Final (March 2006)
Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers
(Issued and Posted 11/13/2006)
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
(September 2006)
Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs
(June 2009)
Review of FDA's Implementation of the Drug Export Amendments of 1986
- Final (November 1998)
A Review of Procedures for the Detection of Residual Penicillin's in Drugs
(November 1977)
Sterile Drug Products Produced by Aseptic Processing
(September 2003)
Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice
(September 2004)
Street Drug Alternatives
- Final (March 2000)
Testing of Glycerin for Diethyl Glycol
- Final (May 2007)
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice
(January 2010)
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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