Course Summary

Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this short course we explain why documentation is so important, identify different types of document required, and set out some simple rules for recording and correcting data.

Who will benefit from this module?

Everyone who works in, or has occasion to enter into, a manufacturing environment in the pharma/biotech industry should have access to this module.

Learning Objectives

• Give reasons why documentation is so important
• Identify types of documents required under GMP
• Outline requirements for instruction documents
• Outline the contents of batch records and requirements for their retention
• Follow good practice in recording and correcting data
• Identify sources of regulations and guidance on computerised systems, electronic records and signatures

Module Outline

Key topics covered in this module include:

• The need for documentation
• Types of documents
• Instructions
• Batch records
• Recording and correcting data
• Electronic records

Assessment - Multiple-choice assessment.