What is GxP and what are predicate rules?

Are they the same? If yes… I keep reading that an overall approach for CSV is conducting a GxP assessment first followed by a 21CFR coverage assessment. If this is right, what does each of this do?

Appreciate it if you could let me know.

Thanks
Sangeeta

Are they the same? If yes… I keep reading that an overall approach for CSV is conducting a GxP assessment first followed by a 21CFR coverage assessment. If this is right, what does each of this do?

Appreciate it if you could let me know.

Thanks
Sangeeta

Hi
Ideally both are different

GxP assesment: you need to check

REGULATED ENVIRONMENT ASSESSMENT
Assessment Questions (A ‘yes’ to any question identifies the system as regulated) YES NO
Does the system manage data that will be submitted to the FDA or EMA? 0
0

Does the system manage data that might be called under regulatory review? 0
0

Does the system have either a direct or indirect impact on another regulated system? 0
0

Is the system used to perform or track regulated activities for GxP facilities or equipment (e.g. validation, calibration, cleaning, maintenance)? 0
0

Is the system used to monitor security, access or regulated communications? 0
0

Is the system used to monitor facilities that affect any regulated system or process? 0
0

Does the system support data storage for any other regulated GxP process (e.g. training, backup, change control, document control)? 0
0

Does the system support data access or availability for any other regulated GxP process? 0
0

Regulated System (check only one) A ‘yes’ to any question above identifies the system as regulated needing Risk Assessment. 0
0

Predicate rules : Predicate rules are the requirements that can be found in part 21 CFR Food and Drugs regulations

Over the years, the practice of validation has been truncated, revised, and reinvented. The old standby of IQ, OQ, and PQ has been criticized by some as not being in step with current technology and evolution of practices. The industry had matured, it was argued, and to such a point that everyone now understands GXP, or good X (variable) practices, including GEP. Though the industry has matured, human nature may not have. Problems of quality still occur and recalls still happen.

[COLOR=“darkred”]-GAMP
-GEP
-SME
-QbD
-QRA
-DoE
-PAT support… etc etc[/color]

Regards