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Introduction
GMP Introduction
GMP - Meaning and Overview
The Main Risks
Why is GMP Important
GMP Directives
GMP Basic Requirements
Quality Systems
Quality System
Principle and Overview
Case Study
Personnel
Principle
Key and qualified personnel
Responsibility Distributions
Staff Training and Hygiene
Premises & Equipment: Production Areas
Premises & Equipment: Production Areas
Storage Area
Quality Control and Ancillary Areas
Equipment
Documentation
Principle
Generation, Control and Types of Documentation
Manufacturing Formula & Processing Instructions
Production
Principle
Prevention of Cross Contamination in Production
Starting Materials and Processing Operations
Packaging Operations
Quality Control
Principle
QC Tasks
Technical Transfer of Testing Materials
Complaints, Recalls & Auditing
Complaints & Recalls
Complaints
Classification of Defects
Recalls
GMP Auditing
Product Traceability
Introduction to Product Traceability in Manufacturing
Benefits of Traceability in Manufacturing
Classification of Product Traceability Studies
Critical Considerations for Traceability
How to Conduct Effective Traceability Studies
Improving Product Traceability Program
Standard Operating Procedures (SOP)
Introduction to SOP Development
Content of an SOP
Steps to Developing a Standard Operating Procedures
Root Cause Analysis (RCA)
History of RCA
RCA Defined
Approaches to RCA
Tools for RCA
Conducting Effective RCA