The Golden Rule: If it wasn’t documented, it didn’t happen!
Good Documentation Practices (GDPs) are requirements for documenting and managing information in a Current Good Manufacturing Practice (CGMP) environment. Every employee, contractor, or guest who documents their activities on CGMP documentation must apply GDP. The FDA (Food and Drug Administration), EMA (European Medicines Agency), and other regulatory agencies inspect CGMP facility documentation for compliance with GDP.
What is CGMP Documentation?
CGMP documentation is any Quality Assurance (QA) or department controlled document used to capture the manufacturing, testing, packaging, holding, and distribution of pharmaceutical or biological products. The table below describes some frequently used CGMP documents that require the use of Good Documentation Practices.
|Batch/Solution Lot Records||QA issued documentation that captures the specific steps in manufacturing a product|
|Laboratory Notebooks||Captures product development and discovery information in the lab|
|Forms||Activity or process specific documentation that captures important steps that are not captured elsewhere|
|Training Documentation||Captures training events and serves as proof of an individual’s competency in performing a task|
|Logbooks||Capture historical maintenance or non-product specific activities related to a room or specific piece of equipment|
|And all other quality controlled documents used to capture the manufacturing, testing, packaging, holding, and distribution of pharmaceutical or biological products!|
Importance of Good Documentation Practices
Applying Good Documentation Practices to your documentation ensures patient safety, inter-site or inter-departmental consistency, regulatory compliance, and traceability.
Do you follow the basic requirements?
|Legible||· Is the text easy to read?|
|Permanent and Indelible||· Was the pen indelible and permanent?
· Was it blue or black?
|Accurate and Concise||· Is the document error free?
· Does the document tell the entire truthful story?
· Can the document be understood from the Administrative Associate to the Vice President?
|Prompt||· Was the information documented at the time of performance?|
|Traceable||· Did everyone sign for what they recorded?
· Do others understand what you recorded and why?
· Can others determine when it was recorded?
· Was an SOP referenced that required the information recorded?
In closing, if current Good Documentation Practice compliance or training is a gap or concern at your organization, don’t hesitate to reach out to Kymanox for a quick, no obligation discussion.
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