WHY GDP?
Used in the Pharmaceutical Industry to define the standards for all documentation
GDP
Clear
What is Legible?
A duplicate that must be stamped, initialed and dated
What is a copy?
05APR2021 or 05/04/21
What are the approved date formats?
Substance Used to hide writing
What is White Out?
An Organized form of information that can serve as legal evidence
Documentation
Correct and Complete
What is Accurate
Helps ensure all pages of a document are included
What is pagination?
Proper method to correct a documentation error
What is a single line cross out, reasoning, initials and date?
Putting an earlier date than the correct date
What is Back Dating?
True or False
GDP only applies to GMP
False, It applies to both GMP & GCP
Unaltered
What is Original
The Overall Accuracy, Completeness and Consistency of data
What is Data Integrity?
Black and Blue
What are the acceptable ink colors?
A place where data or observation should not be recorded
What is scrap paper?
351-SOP-002959
BI-VQD-24662
What is our SOP on Good Documentation Practices?
Global or Local
In Real time
What is Contemporaneous?
Entries are timestamped in order
What is consistent?
The person who witnesses the performer complete a GMP task. This person is also trained in the process and is able confirm and document that the task has been completed correctly
Who is the Verifier?
Area left blank on a page needs...
What is an N/A?
Findings, Observations, Damaged Product, Plant Shut Down, Recalls, Fines
What are results of poor documentation Practices
Who/When /Why
Attributable
Person responsible for ensuring documentation is correct
Who is EVERYONE?
indicates that the person agrees with the information provided or conclusions in the record and is accountable for the documents
What is your signature?
Action of recording inaccurate results that will lead to disciplinary actions taken?
What is falsifying data?