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42 BioPharm International eBook December 2019 www.biopharminternational.com
Regulatory Sourcebook Resources
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Access key regulatory and standard setting
resources, guidance documents, and guidelines
by clicking on the title of the document.
Resources, Guidelines,
and Guidance Documents
T
he regulatory nature of the bio/
pharmaceutical industry requires
close adherence to regulations,
good manufacturing practices, and
guidelines. The websites of regula-
tory authorities provide information
to assist drug development and manu-
facturing organizations in navigating
the regulatory process. This section
lists information sources to key topics;
click the appropriate link to access the
online information.
The following pages list key guid-
ance documents f rom FDA, the
European Medicines Agency (EMA),
t h e Wo r l d H e a l t h O r g a n i z a t i on
( W H O ) , a n d t h e I n t e r n a t i o n a l
Council for Harmonisation (ICH)*.
US FOOD AND DRUG
ADMINISTRATION RESOURCES
• FDA Human Drugs
• FDA Animal/Veterinary Drugs
• FDA Vaccines, Blood, and
Biologics
• FDA Cellular & Gene Therapy
Products
• FDA Compliance Actions and
Activities
• FDA Development & Approval
Process
• FDA Drug Shortages
• FDA Guidance Documents
• FDA New Drug Approvals
• FDA Regulatory Science
• FDA Rules and Regulations
• FDA Warning Letters
US REGULATIONS
• Code of Federal Regulations, Title
21, Food and Drugs
• Federal Register Notices Pertaining
to Drugs
FDA GUIDANCE DOCUMENTS
• Advancement of Emerging
Technology Applications for
Pharmaceutical Innovation and
Modernization Guidance for
Industry (PDF)
• Analytical Procedures and
Methods Validation for Drugs and
Biologics (PDF)
• Assay Development and Validation
for Immunogenicity Testing of
Therapeutic Protein Products,
Draft Guidance (PDF)
• CMC Postapproval Manufacturing
Changes To Be Documented in
Annual Reports (PDF)
• Comparability Protocols for
Human Drugs and Biologics:
Chemistry, Manufacturing, and
Controls Information Guidance for
Industry, Draft Guidance (PDF)
• Contract Manufacturing
Arrangements for Drugs: Quality
Agreements (PDF)
• Current Good Manufacturing
Practice for Phase 1 Investigational
Drugs (PDF)
• Data Integrity and Compliance
With Current Good
Manufacturing Practice Guidance
for Industry (PDF)
• Elemental Impurities in Drug
Products Guidance for Industry
(PDF)
• Guidance for Industry - Container
and Closure System Integrity
Testing in Lieu of Sterility Testing
as a Component of the Stability
Protocol for Sterile Products (PDF)
• Harmonizing Compendial
Standards With Drug Application
Approval Using the USP Pending
Monograph Process Guidance for
Industry, Draft Guidance
• INDs for Phase 2 and Phase 3
Studies Chemistry, Manufacturing,
and Controls Information (PDF)
• PAT — A Framework for
Innovative Pharmaceutical
Development, Manufacturing, and
Quality Assurance (PDF)
• Postapproval Changes to Drug
Substances Guidance for Industry,
Draft Guidance (PDF)
• Preparation of Investigational
New Drug Products (Human and
Animal) (PDF)
• Process Validation: General
Principles and Practices (PDF)
• Quality Systems Approach
to Pharmaceutical Current
Good Manufacturing Practice
Regulations (PDF)
• Sterile Drug Products Produced
by Aseptic Processing — Current
Good Manufacturing Practice
(PDF)
• Using the Inactive Ingredient
Database Guidance for Industry,
Draft Guidance