PHASE II INVESTIGATION:
The conclusion of QC lab investigation affirmed that the failed results reported for TG89 bottom mixer bowl and the bottom of the Vibrasonic clear were not due to Analyst error. Therefore, QA initiated a Phase II investigation to determine the circumstances that led to the failures. During the investigation QA reviewed the cleaning protocol, current cleanup instructions, interviewed SMEs. Below is a summary of the findings. Note, due to the fact the failure was reported for both the bottom of the bowl and the Vibrasonic /Ultrasonic cleaner, the findings were summarized for each one individually.
PROCEDURE: CLEANUP SHEET
1- The Ultima Gral (TG89) is a high speed mixer used in the Granulation Area for processing …show more content…
However, review of the TG89 #3 cleanup sheet (form I271B) showed that there are no cleaning instructions available to prevent future incidents. Per the aforementioned cleanup sheet, the operator is only required to drain the Vibrasonic cleaner when the product filter cleaning is complete. Therefore, lack of cleaning instructions was identified as the root cause for the swab failure reported. As stated above, a proposed cleanup sheet revision attached to the new cleaning change form (CCF #5509) includes instructions for the cleaning of the Vibrasonic …show more content…
Per the new CCF #5509, between batches of different products cleanliness must be demonstrated until SOP I271 is revised to address cleaning difficulties experienced during the annual monitoring study.
HISTORICAL REVIEW:
A historical review search was performed in TrackWise for previous records relating to bottom of Vibrasonic cleaner near drain for TG89 failed swab analysis. The following criteria were used for the review:
Scope: CRO - All Records (pub)
Brief Description: contains any of “TG89" "TG89 89" "TG089" "Vibrasonic" "Ultrasonic" " Ultrasonic cleaner" "TG89 mixer bowl"
Include Closed Records
TRACKWISE historical was run for deviation opened due to similar and related deviations opened within a twelve month period. Two records, including the current investigation, were found.
• DR 125821 - Opened on 04/19/2017 (related). Bottom of Vibrasonic cleaner near drain for TG89 failed swab analysis for Glipizide. The root cause was identified as insufficient cleaning performed.
Concerning the failure for the Vibrasonic, a trend was identified as this was the second failure reported. Concerning the bottom of the mixer bowl, no additional records were found, thus no trend was
The conclusion of QC lab investigation affirmed that the failed results reported for TG89 bottom mixer bowl and the bottom of the Vibrasonic clear were not due to Analyst error. Therefore, QA initiated a Phase II investigation to determine the circumstances that led to the failures. During the investigation QA reviewed the cleaning protocol, current cleanup instructions, interviewed SMEs. Below is a summary of the findings. Note, due to the fact the failure was reported for both the bottom of the bowl and the Vibrasonic /Ultrasonic cleaner, the findings were summarized for each one individually.
PROCEDURE: CLEANUP SHEET
1- The Ultima Gral (TG89) is a high speed mixer used in the Granulation Area for processing …show more content…
However, review of the TG89 #3 cleanup sheet (form I271B) showed that there are no cleaning instructions available to prevent future incidents. Per the aforementioned cleanup sheet, the operator is only required to drain the Vibrasonic cleaner when the product filter cleaning is complete. Therefore, lack of cleaning instructions was identified as the root cause for the swab failure reported. As stated above, a proposed cleanup sheet revision attached to the new cleaning change form (CCF #5509) includes instructions for the cleaning of the Vibrasonic …show more content…
Per the new CCF #5509, between batches of different products cleanliness must be demonstrated until SOP I271 is revised to address cleaning difficulties experienced during the annual monitoring study.
HISTORICAL REVIEW:
A historical review search was performed in TrackWise for previous records relating to bottom of Vibrasonic cleaner near drain for TG89 failed swab analysis. The following criteria were used for the review:
Scope: CRO - All Records (pub)
Brief Description: contains any of “TG89" "TG89 89" "TG089" "Vibrasonic" "Ultrasonic" " Ultrasonic cleaner" "TG89 mixer bowl"
Include Closed Records
TRACKWISE historical was run for deviation opened due to similar and related deviations opened within a twelve month period. Two records, including the current investigation, were found.
• DR 125821 - Opened on 04/19/2017 (related). Bottom of Vibrasonic cleaner near drain for TG89 failed swab analysis for Glipizide. The root cause was identified as insufficient cleaning performed.
Concerning the failure for the Vibrasonic, a trend was identified as this was the second failure reported. Concerning the bottom of the mixer bowl, no additional records were found, thus no trend was