Related FDA483/Warning Letter
The written stability program for drug products does not describe the storage conditions for samples retained for testing.
Sub section (b)There is no written standard operating procedure in place to (A) control, secure, and allow authorized personnel to access the stability chambers. It appears that currently established system allows access to every employee of the firm with probability to (B) misplace and/or change the stability samples without (C) formal/official chain of custody.
IF IT’S NOT DOCUMENTED IT’S NOT DONE
- SOP should discuss chamber access and security.
A. Who’s allowed to enter
B. Who’s allowed change setting
C. Who’s responsible for documentation
2. Who can remove samples from the chamber
A. What is the inventory process control
1. Each withdrawal/monthly/yearly/start-end
3. How do you document the day/time a sample is removed from the chamber
Needs to be discussed in the SOP.
- Who allows anyone to remove products from the chambers?
- Who allows only a specific group?
- Are all entries documented? I.E. Written/electronic
- Who has an inventory system? How often is it verified?
- Who has a chain of custody? How is it documented?