Good Documentation Practice - GDocP
Course Description:
A robust Quality Management System (QMS) is paramount in meeting Good Manufacturing Practice regulations. To ensure its robustness, Cosmetics manufacturing companies must ensure that all activities which influence the quality of cosmetics and personal care products are well-documented. QMS documentation serves not only to provide clarity on required steps but also ensures processes can be accurately recorded and evaluated for efficacy compliance purposes. Following Good Documentation Practices (GDocP) will prove data integrity and ensure consistency and high Quality always.
This course takes you through, how to create GMP documents, how to record and fill in the information and maintain good control of the documentation system so that the right version is always being used. It takes you through all the dos and don’ts of managing documentation in a GMP environment.
Learning Outcome:
- Understand what Good Documentation Practice is
- Understand the importance and benefits of following Good Documentation Practice
- Describe the general GMP requirements for creating and maintaining documentation
- Understand the requirements for filling GMP documents
- Identify the requirements that should be followed while modifying records and recording numbers
- Understand how to manage attachments and printouts
- Understand the different phases of the document lifecycle
- Identify who is involved at each stage
- Understand the documentation approval process
- Understand what Good Documentation Practice is
- Understand the importance and benefits of following Good Documentation Practice
- Describe the general GMP requirements for creating and maintaining documentation
- Understand the requirements for filling GMP documents
- Identify the requirements that should be followed while modifying records and recording numbers
- Understand how to manage attachments and printouts
- Understand the different phases of the document lifecycle
- Identify who is involved at each stage
- Understand the documentation approval process
Course Features
| Modules | : | 4 |
| Duration | : | 3 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Cosmetics Good Documentation - Types of Documents (CPDP0401)
This is an introductory module that covers the different types of Documents that are created and used in a GMP environment. You will understand the difference between records and documents and what types of documents are required to be in compliance with GMP.
Cosmetics Good Documentation - Document Control System (CPDP0501)
This module covers the document life cycle and the controls required to ensure the accuracy, integrity and availability of different types of GMP documents, including archived documents in order to be in compliance with GMP.
Cosmetics Good Documentation - Introduction - Creating (CPDP0101)
This module covers the fundamentals of the Good Documentation Practice (GDocP) to follow when creating new documents that will be used in a Good Manufacturing Practice (GMP) environment. It gives all the ‘Dos’ and ‘Don’ts’ to follow to ensure the quality of documents created will support elements of data integrity and Good Documentation Practice.
Cosmetics Good Documentation - General Rules - Filling (CPDP0201)
This module covers the fundamentals of the Good Documentation Practice (GDocP) to follow when filling in documents to record the activities being performed in a Good Manufacturing Practice (GMP) environment. It gives all the ‘Dos’ and ‘Don’ts’ to follow when recording information.