Cosmetics GMP Document Lifecycle: Concepts
This course covers the types of GMP-related documents required to show compliance in a regulated environment and how to create, maintain, and improve a Document Management System to establish proper document control practices.
Overview
In a regulated environment, companies must follow a controlled process to manage documents. This process, known as the document lifecycle, outlines the journey a document takes from its creation to its eventual archival or destruction. It provides a systematic approach to creating, managing, and storing all documentation to ensure compliance with Good Manufacturing Practices (GMP) requirements. This course will cover the document lifecycle and the roles of individuals involved in the document control process.
Good Documentation Practices are a crucial aspect of the quality assurance system and relate to all elements of GMP. The primary objective of documentation is to establish, control, monitor, and record all activities that directly or indirectly affect product quality. The manufacturer’s Quality Management System should clearly define the types of documents and media used. This course will provide a comprehensive overview of the various types of documentation required to comply with GMP regulations. It will cover the distinction between records and documents and explain the essential documentation needed to ensure compliance.
You will learn:
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To identify the two primary types of documentation
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To understand the purpose of each type of documentation
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To recognize the mandatory information that should be captured in various documents and records
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To identify the different stages of the document lifecycle
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How to maintain documents
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How to comply with the retention and archival of documents
Agenda
- Cosmetics Good Documentation Practice – Types of Documentation
- Cosmetics Good Documentation Practice – Document Control System