This document provides an overview of Good Manufacturing Practice (GMP) requirements for pharmaceutical manufacturers in the US, EU, and Japan. It discusses the different regulatory authorities for each region, including the FDA, EMA, and PMDA. The document also outlines the key topics that will be covered, such as ICH guidelines, GMP compliance and inspections, differences between regions, and specifics on FDA, EU, and Japan inspections. The goal is to highlight both the commonalities and differences in GMP standards and inspection focus internationally.

1. US, EU & Japan GMP Requirements: Practical ICH
Area Differences & Healthcare Inspection Focus
Presenter
Angela Bazigos
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GMP compliance is a must for manufacturers of finished pharmaceutical products and
active pharmaceutical ingredients (APIs), according to the different national
legislations.

2. Contents
 Health Care Authorities
 Good Manufacturing Practices
 International Council of Harmonization
 ICH Details
 GMP Compliance & Inspections
 Internal GMP Inspections / Audits
 External GMP Inspections / Audits
 Inspection Walkthrough & Review
 Differences by Region
 FDA Inspection Specifics
 EU Inspection Specifics
 Japan Inspection Specifics
 FAQ
 Summary
 References
 Q & A
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3. HealthCare Authorities
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4. FDA
 Today, the FDA regulates $1 trillion worth of
products a year.
 It ensures the safety of all food except for meat,
poultry and some egg products
 It ensures the safety and effectiveness of all
drugs, biological products (including blood,
vaccines and tissues for transplantation), medical
devices, and animal drugs and feed
 It ensures the safety of cosmetics products
 It ensures that any medical and consumer
products that emit radiation do no harm.
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5. Organizational Structure
The purpose of this is to provide an overview of the organizational
structure of the offices involved in compliance related functions within
FDA. It is not the intent to provide a complete description of FDA's
organizational structure:
1. OFFICE OF REGULATORY AFFAIRS (ORA)
2. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
3. CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
4. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
5. CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
6. CENTER FOR VETERINARY MEDICINE (CVM)
7. CENTER FOR TOBACCO PRODUCTS (CTP)
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6. To see the complete presentation check the below link:
http://www.audioeducator.com/pharma-biotech/us-eu-japan-gmp-
requirements-08-06-14.html