cGMP Overview
This is what GDP stands for
Good Documentation Practices
Good Documentation Practices
These are the acceptable ink colors for documentation.
Blue or Black
Making sure your handwriting can be read by someone else refers to this term in ALCOA.
Legible
cGMP stands for
Current Good Manufacturing Practices
These employees are responsible for practicing GDP,cGMP
Everyone
This has to be next to any correction or notation
Initials and date
Information being recorded at the same time it occurs refers to this term in ALCOA
Contemporaneously Recorded
The accuracy, completeness, and quality of data as it's maintained over time and across formats is the definition of this term.
Data Integrity
The importance of data integrity impacts these things
Safety, Quality, Efficacy of Product
TRUST!
Proper dating format includes the following.
MM-DD-YYYY
DD-MMM-YYYY
Making sure information is correct and complete refers to this term in ALCOA
Accurate
GDP is required when manually documenting in these
Batch records, notebooks, lab work, controlled data sheets (ex: cleaning logs) , validation documentation, training documentation
Eliminating/destroying data, intentionally deleting information is considered this
Data Falsification/Fraud
When making a correction to a mistake in data we must use this
Error explaintaton/footnote
A document being in the same condition it was when it was recorded refers to this term in ALCOA
Original (or true copy)
Audit trails and Automation Records are examples this type of record
Electronic Records
Data must be recorded when?
Real time (no backdating or predating)
Blank spaces must be filled with this.
Straight line, N/A, initial and date
Knowing who recorded information or what batch data belongs to refers to this term in ALCOA.