To lay down the Procedure for preparation of Investigation of Laboratory Failure Results During Stability Studies.
This Procedure is applicable to provide the guidelines for preparation of Investigation of Laboratory Failure Results During Stability Studies
QC and QA personnel shall be responsible for follow the procedure mention in this SOP.
QC manager and QA Head shall be accountable for compliance of this SOP.
- On observation of out of limit results during stability studies Analyst shall inform to Head QC.
- Head QC shall arrange the investigation for Laboratory error and instruct chemist to retain the sample for investigation purpose.
- If any instrument or analyst error is identified, Head QC shall take necessary corrective action to rectify the error and take decision of retesting.
- The sample used for retesting should be taken from the same aliquot / same batch.
- In case of clearly identified laboratory error, the retest results would substitute for the original test results.
- Head QC shall arrange training of analysis if personnel error identified and also document the training activity.
- Incase of no assignable cause is found during lab investigation, Head QC shall take decision of retesting the same sample in triplicate.
- The original results may be invalidated if triplicate determination is acceptable with in limit and RSD of triplicate determination is less than 2%.
- In case of failure confirmed during accelerated stability studies Head QC shall inform to Head QA for further investigation and initiate intermediate stability studies as applicable as per protocol.
- In case of failure confirmed during long-term stability studies Head QC shall inform to Head QA for further action.
- Head QA shall investigate the process along with production in case of new process. Head QA shall initiate the recall of the product from market and take necessary regulatory action and evaluate the product for reassigning the shelf life and storage conditions.
QC – Quality Control.
QA – Quality Assurance
RSD – Relative Standard Deviation
- DISTRIBUTION LIST
10.0 HISTORY OF REVISION:
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