GDP Basics
What does GDP stand for?
Good Documentation Practices
Why are post it notes not permitted?
The note can be lost, and all information should be entered into the document.
What should you do if you find an error in a document?
immediately notify your lead or supervisor
What does "Legible" mean in ALCOA+?
data must be recorded permanently and be readable
The person who executed the task.
Why is GDP important in the manufacture of pharmaceutical products?
so we are able to trace actions, maintain quality standards and adhere to regulatory requirements
Why are Gel pens not permitted?
The gel can bleed through the pages, blur out numbers that can't be identified. Both of which make the document not legible.
What are considered unacceptable ways to correct a GDP compliant document?
using erasers, whiteout, blackout, cross-outs, or other methods that remove or try to coverup the original entry
What does "Original" mean in ALCOA+?
first source of data or observation
Who signs the verified by section?
A second qualified person who independently confirms the critical step was performed
In GDP, what does ALCOA stand for
Attributable, Legible, Contemporaneous, Original, and Accurate
Pencils are not permanent and may fade over time.
What is the consequence of having missing or incorrect dates in a GDP compliant document?
it violates the principle of contemporaneous in GDP
What does "Complete" mean in ALCOA+?
all data including any repeat or reanalysis performed
Who signs the certified by section
A formal Quality Assurance authority declaring the entire document is complete, true, and authentic
How should mistakes be corrected in a document following GDP
a single line through the mistake and then initialing and dating the correction (footnote)
What types of pens can be used for documentation following GDP principles?
blue or black ballpoint pens
Why is overwriting corrections in a document not allowed?
it makes the document illegible and complicates the tracing of activities
What does "Available" mean in ALCOA+?
it can be accessed for review, audit, or inspection over the lifetime of the record
What does the principle “If it wasn't documented, it didn't happen" mean
the principle means if the task was not documented it is considered not completed
Why is GDP important in the manufacture of pharmaceutical products?
to ensure traceability, maintain quality standards and adhere to regulatory requirements
Why are certain writing tools like 'pens' important for documentation?
to ensure that data entries are durable/lasting and can be easily read
What are the date formats to use in a GDP compliant document?
MM/DD/YY or MM/DD/YYYY or DD/MMM/YYYY
What does "Contemporaneous" mean in ALCOA+?
activities must be recorded at the time they occur
What can happen if documentation does not meet the standards set by regulatory bodies?
possible non-compliance, which could lead to fines, penalties, and damage to the company's reputation