GDP - Good Documentation Practices: An Easy to Understand Guide (Site Wide Licence)
There are few stated requirements for Good Documentation Practices (GDP), instead, it’s an expected practice and not stated or included in any Code of Federal Regulations (CFR) requirement.
Document Standards
The standards around document control indicate things like documents are to be approved with date and signature and when changes to approved documents are made, the updates are re-approved by the same individuals or functions that originally approved the document. This is far from comprehensive, though and in an audit, GDP violations can lead to non-conformances. Worse, if the data is called into question in a court of law, the repercussions can be devastating for a company. Either way, GDP violations can cost the company time and money. Thus, its imperative that all employees are trained in, understand, and practice GDP.
Module Overview
GDP
GDP is expected from the moment design controls are enforced through manufacturing and post-market surveillance. A sampling of document and record types where GDP is a consideration includes:
- Training Records
- SOPs
- Internal Audit Results
- Research and Development Trade Studies
- Formulas and Calculations
- Manufacturing Routers and Assembly Checklists / Records
- Verification and Validation Protocols and Results
Receiving / Incoming Inspection Records
Clear Documentation
The purpose of good documentation practices is to clearly document the actions that took place in the development or manufacture of a drug, devices, etc., so that the veracity of the information cannot be questioned. Controlled records are legal documents, so the data needs to be clearly documented in a manner that can withstand legal scrutiny.
In the drug / device industry, good documentation practices are applied to all records maintained in the Quality System, including both product and process records. Everyone has heard the statement: ‘If you didn’t document it, then it didn’t happen’; however if GDP is not followed, the documents may not be admissible.
Learning Management Systems:
Each module can be integrated into any learning management system
Questions & Answers
If you have any questions regarding this module please feel free to contact us now
Duration
30 mins
Cost
€2499 for an site wide licence
Individual License also available
Click here to purchase and individual license
