Learning Objectives

This ebook (PDF format) will introduce you to Good Documentation Practices  providing you with the necessary know-how to seamlessly implement GDP best practices. GDP or GDocP is required by governing bodies such as the FDA and CFR in the US and the EMEA in Europe. Documentation that is used during the manufacturing of product, laboratory test results, procedures and quality records must meet GDP requirements.

Target Audience

This ebook is ideal for those requiring an introduction to the key principles of Good Documentation Practices as well as more experienced engineers looking to refresh existing knowledge and understanding of GDP.  

Overview of Contents

• What Is GDP? 
• Why Is Good Documentation Practice Essential? 
• What Type of Documentation Should Follow GDP? 
• What Are the Elements of GDP? 
• Document Creation 
• Document Approval 
• Signatures 
• Date and Time Format 
• Hand Written Entries 
• Blank Fields 
• Data Transcription 
• Revision Control 
• Management of Attachments 
• Management of Documents through Lifecycles 
• Test Results  and much more.