Good Documentation Practices
The Do’s & Don’ts of Good Documentation When Writing in cGTP Documents
We will cover the standards that will guide you as you perform some of the following critical steps in your documentation:
- Corrections:
- Deviations:
- Voiding Records:
- Re-creating and Re-writing Records
- rounding off rules:
Why Attend This Course?
This course will help provide you with some of the minimum standards, reasoning and rules that you will be required to provide when completing current Good Tissue Practices (cGTP) documentation.
In a facility that maintains compliance with current Good Tissue Practices (cGTP) or any other regulated environment, numerous types of documentation exist and serve a variety of functions. Examples of the functions of documentation include:
- Providing a record of what was done
- Instructing an individual on how to perform tasks
- Defining specifications
- Ensuring traceability
- Providing evidence that a product was made according to regulatory or in house requirements.
The Golden Rule of Good Documentation: Documentation must be done concurrently with the performance of each step; must be accurate, indelible, and legible, identifying the person performing the work, and the date of the entry.
When you place your signature or initial on a cGTP document, you have validated that you have just completed that activity in the view of the FDA. cGTP documents and records include, but are not limited to:
- Standard Operating Procedures (SOPs)
- Informed Consent
- Donor Screening (Medical, Social, Sexual History)
- Donor Testing
- Recovery Operations
- Receipt and Storage of HCT/Ps
- Processing and Processing Controls (Batch Records)
- Facility Cleaning and Maintenance
- Equipment Cleaning and Maintenance
- Environmental Monitoring
- Receipt and Inspection of Supplies and Reagents
- Product Testing
- Product and Sample Labeling
- Analytical Methods
- Validation Documents: Examples: Sterilization Process Validation
- Complaint File
- Corrective Actions
- Deviations
If you've tried “Googling” the FDA requirements for Good Documentation Practices (GDP), you'll find that they don't exist because it's an expected practice and not a Code of Federal Regulations (CFR) requirement.
Who Should Attend This Course
The rules set forth in documentation apply to all personnel in a regulated organization. Individuals involved with obtaining informed consent, donor screening, recovery operations, receipt, processing, testing, support, packaging, labeling, and distribution of FDA regulated materials will be expected to know and abide by the common rules of documentation.
Download the Course Brochure
Caution!
Willful noncompliance with the documentation practices outlined in the GDP SOP should result in dismissal and possible criminal prosecution.
It’s the Law!
It’s Good Business Practice!
It’s Best Industry Practice!