Types of Documentation
Course Description:
Good Documentation Practice (GDocP) is a regulatory requirement as part of European and FDA legislation for Good Manufacturing Practice (GMP). GDocP is an essential part of the quality assurance system and is key to showing data integrity in a GMP environment. The various types of documents and media used should be fully defined in the manufacturer's Quality Management System. From differentiating between records and documents, to identifying what types must be in place for compliance with GMP regulations - this course will provide an all-encompassing overview on types of documentation required in a GMP system.
Learning Outcome:
- Understand the difference between a record and a document
- Identify the main categories of documents required in GMP
- Describe the purpose of each type of document
- Identify the mandatory information that should be captured in various documents and records
- Understand the difference between a record and a document
- Identify the main categories of documents required in GMP
- Describe the purpose of each type of document
- Identify the mandatory information that should be captured in various documents and records
Course Features
| Modules | : | 1 |
| Duration | : | 30 Minute(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
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.