Related FDA483/Warning Letter
6, Initial qualification and routine calibration, maintenance and cleaning of automatic, mechanical, and electronic. equipment is not performed according to a written program designed to assure proper’ performance
Initial setup of the unit should include a Design Qualification (DQ) to ensure that the unit is correct for the lab. The Installation Qualification (IQ) should be performed to document that the requirements of the DQ were met. When performing the Operating Qualification (OQ)/Performance Qualification (PQ) the same thought process used for installing a new storage chamber, should be used when developing a protocol. The protocol needs to run for 24 hours or according to your company’s policy, in both the empty and full capacity tests. A door test should be performed to show the recovery capabilities of the unit when samples are removed. The protocol should document a temperature out-of-spec alarm to answer any questions about leaving the door open.
During the OQ/PQ a mapping of the unit should document and support the placement of the monitoring thermometer or Electronic Monitoring System (EMS) probes(s). A discussion of the rational used should be included in the final report for this probe placement. This mapping gives you a base line for Quality decisions when looking at excursions when the sample may have been placed in this chamber.
This initial mapping should be considered as a full validation and all supporting documents should be included in the Validation package. The unit should be included on the labs VMP to show the units past mapping and future scheduled work.
Related FDA483/Warning Letter
- c) All thermometers used in the refrigerator, incubator, autoclave, and compounding processes lacked calibrations against an NIST-standard. The temperatures of your refrigerator and freezer used to store components and finished drug products are not monitored daily to ensure that proper storage conditions arc maintained
A daily check of the unit should be performed and recorded either manually or electronically. These records should be retained according to your Records Retention Policy.
When installing an EMS after the unit has been mapped, it is acceptable to use the previous mapping as a justification for the placement of the probe(s). A reference to the addition of the probes and the calibrations documents should be added to the chamber validation package in the form of a memo describing the EMS and supporting documentation of work performed. If possible, a remapping at the time the EMS is installed could be done to show proactivity to possible questions on the changeover. The EMS needs to be validated before the change in daily check process. The change in processes needs to be clearly documented to avoid confusion during audit discussions. The check process needs to be documented and described in an SOP.
The EMS validation package should contain copies of the calibration documents used on the installed probes. Future validations should include a probe next to the EMS probe as well as next to the controlling probe. Calibration of the EMS probe(s) needs to be set up on a schedule similar to the thermometer that it replaced.
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