GDP Basics
What does GDP stand for?
Good Documentation Practices
What is SAP ERP?
a tool used for managing manufacturing processes
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
How should the 5th page of a 25 page document read?
Page 5 of 25
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
What is OneVault used for?
a document control/management system for policies, procedures, clinical guidelines, etc.
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
What is the AbbVie Code of Conduct's stance on sharing passwords?
passwords should remain private and never be shared
In GDP, what does ALCOA stand for
Attributable, Legible, Contemporaneous, Original, and Accurate
What is Compliancewire used for?
a web-based learning management system (LMS) primarily used by companies to deliver training and manage employee qualifications
What is the consequence of having missing or incorrect dates in a GDP compliant document?
it violates the principle of contemporaneous in GDP and may incur an ER
What does "Complete" mean in ALCOA+?
all data including any repeat or reanalysis performed
What is the role of GDP in AbbVie's commitment to patient safety?
their role is to ensure documentation standards are maintained, preventing errors that could negatively impact product quality and patient safety
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
What is the problem with overwriting corrections in a document?
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 was not written down, it did not happen" in AbbVie's code of conduct mean?
the principle means we should have documents that say what was done accurately and is complete in all information needed
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 acceptable 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