cGMP Overview
cGMP stands for
These employees are responsible for following cGMP, GDP, and Data Integrity practices
Everyone
These are the acceptable ink colors for documentation.
Blue or Black
What principle refers to the data being accessible for review, audit, or inspection over the records lifetime?
Available
What is required to ensure data is attributable in an electronic format?
Unique logins
The accuracy, completeness, and quality of data as it's maintained over time and across formats is the definition of this term.
Data Integrity
Eliminating data, intentionally destroying records, and writing over data is considered this
GDP is required when documenting in these
All GMP Documents (notebooks, batch records, forms, templates, etc)
What principle emphasizes that data should be recorded at the time it is performed, not backdated or predated?
Contemporaneous
What record is reviewed to ensure the data is attributable?
Audit Trails
What is the regulatory framework that emphasizes data integrity practices in pharmaceuticals? (US)
21CFR Part 211
Data Integrity is important to maintain these things? (one in particular)
Safety, Quality, Efficacy of Product
TRUST!
Proper dating format includes the following.
MM-DD-YYYY
DD-MMM-YYYY
What term refers to the first written copy of an action or piece of data?
Original
What is the process of examining and evaluating a process or system to identify and resolve any issues?
Validation
Audit Trails, OpenLab Reports, DeltaV, PI are examples of...?
Electronic Records
What is the most important thing we build in order to maintain Data Integrity?
Foundational Practices (Culture of Accountability, Robust Policies/Procedures)
When making a correction to a mistake in data we must use this
Initials/Dates and an error explaintaton/footnote
What term describes the concept of ensuring data remains unchanged and unaltered?
Enduring
What terms refers to the prevention of unauthorized access, modification, or deletion of data?
Access Control
What outlines rules for data management consisting of how people, processes, and technology work together to maintain data integrity?
Data Governance
What process in the QMS involves pulling reports/data to review and evaluate the effectiveness of systems?
Metric Review
What ensures accuracy and completeness of data documented?
Data Verification/Review
What principle refers to the concept of ensuring data matches predefined expectations?
Consistent
Who is responsible for reviewing audit trails?
All Data Reviewers