Good Documentation Practice
Course Description:
Compliance with Good Manufacturing Practice regulations is crucial in the pharmaceutical industry. A robust Quality Management System (QMS) is key to meeting these regulations.
Pharmaceutical industries must ensure that all activities that impact the quality of medicinal products are well-documented to ensure the robustness of their QMS. Proper documentation not only provides clarity on required steps, but it also guarantees that processes can be accurately recorded and evaluated for compliance purposes.
This course covers the best practices of Good Documentation Practices (GDocP) to ensure data integrity, consistency, and high-quality outputs. It will guide you through creating GMP documents, filling in information, and maintaining good control of your documentation system to ensure the correct version is always used.
Learn the dos and don'ts of managing documentation in a GMP environment.
Learning Outcome:
- Learn what Good Documentation Practice is
- Know the importance and benefits of following Good Documentation Practice
- Understand how GMP documents should be filled
- Understand how to modify records if required
- Learn the different phases of the document lifecycle
- Know how GMP documents are approved
- Learn what Good Documentation Practice is
- Know the importance and benefits of following Good Documentation Practice
- Understand how GMP documents should be filled
- Understand how to modify records if required
- Learn the different phases of the document lifecycle
- Know how GMP documents are approved
Course Features
| Modules | : | 6 |
| Duration | : | 5 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
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Course Content(s)
Introduction to Good Documentation Practice (PHDP0602)
Good Documentation Practice are important set of guidelines to follow in a Good Manufacturing Practice (GMP) environment. Documentation is used to ensure and prove robustness of the Quality System. This module gives the overview why GDocP is important and what its main principles are. It explains, the document life cycle and how having standardised ways of working will ensure data integrity, high quality and above all patient safety.
Types of Documents (PHDP0302)
This introductory module gives a comprehensive guide to understanding the importance of documents within Good Manufacturing Practice (GMP). Understand the difference between a record and a document. Know what documents are required in Production and Quality Control and what is a Site Masterfile. Download the checklist to ensure your documents are collecting all the required information.
Document Control System (PHDP0402)
To ensure data integrity, all Good Manufacturing Practice (GMP) documents must go through the lifecycle of creation, maintenance, and archiving. This process has to be controlled and managed properly. This module takes you through the fundamentals of managing documents in a Good Manufacturing Practice (GMP) environment.
Creating and Maintaining Documentation (PHDP0102)
There are certain rules that need to be followed when creating Good Manufacturing Practice (GMP) documents. This module will take you through all the "dos" and "don'ts" to follow to ensure high quality of documents are created. These rules are important and support elements of data integrity and Good Documentation Practice.
Filling and Recording Information (PHDP0202)
When recording information in a Good Manufacturing Practice (GMP) document, there are certain rules that must be followed to ascertain the integrity of the information that is being recorded. 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 GMP environment. It gives all the "dos" and "don'ts" to follow when recording information.
Amending Recorded Information (PHDP0502)
It is likely that errors will occur when recording information in a Good Manufacturing Practice (GMP) document. To correct these errors, there are certain rules that must be followed to ascertain the integrity of the information being recorded. This module covers the fundamentals of the Good Documentation Practice (GDocP) to follow when amending data entry in documents.