GDP is commonly abbreviation for Good Documentation Practice. It has been recommended to be abbreviated as GDocP to distinguish from “good distribution practice” also abbreviated GDP. Now, GDP is a term in the regulated industry to characterize standards by which documents are created and maintained.
In both pharmaceutical and medical device environment documentation plays a crucial role in meeting the essential requirements to ensure product quality and safety. Documentation provides both:
- Information on when, where, who, why and how to complete tasks, and
- Evidence proving that the tasks have been completed as they should be.
If for any reason an instruction or record is not documented properly, then the QA/QC team or the manufacturer of a product as well as patient safety can be affected, to the extent of bringing a negative impact on the organization. The guidelines of documentation within your organization can directly impact the success of an Audit situation. Consequently, GMP / GLP / GCP regulations from PIC/S, FDA, ICH and EU all include mandatory sections on documentation.
Why You Should Attend:
As the FDA and TGA say “If it isn’t written down, then it didn’t happen”
To meet industry standards, it is critical that all documentation follows GDP when it affects:
- GMP / GLP / GCP processes
- Material or product identity, quality, purity, strength and safety
- The validated state of GMP / GLP / GCP product manufacture, facilities, equipment, computer systems and testing methods.
It is a best practice, that all companies have a policy or procedure outlining the expected GDocP standards, especially for those specifics that may be exclusive to your organization – for example, using a distinct pen color or when and how to use scanned documents/records as original data.
Areas Covered in the Session :
- Basics of Good Documentation Practices
- Documents vs records
- How to write or record information in a compliant way (includes text, numbers, electronic signatures etc)
- How to amend documents or records in a compliant way
- Specific contents will include but are not limited to:
- Document Creation
- Document Approval
- Handwritten Entries
- Copies of Documents
- Document Maintenance
- Document Modification
- Warning Letters for GDocP
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- IT and Software Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Validation Departments
- Marketing Departments
- Documentation Departments
- Laboratory Professionals
- Clinical Research Associates
- GXP Professionals
- Everyone that creates records in a regulated industry
FDB1600
