Preview Good Manufacturing Practices (GMP)

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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

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

Preview - Good Manufacturing Practices (GMP)