INVESTIGATION OF LABORATORY FAILURE REULTS DURING STABILITY STUDIES

nirvesh400

1.0   OBJECTIVE

To lay down the Procedure for preparation of Investigation of Laboratory Failure Results During Stability Studies.

  • SCOPE

This Procedure is applicable to provide the guidelines for preparation of Investigation of Laboratory Failure Results During Stability Studies

  • RESPONSIBILITY

QC and QA personnel shall be responsible for follow the procedure mention in this SOP.

  • ACCOUNTABILITY

QC manager and QA Head shall be accountable for compliance of this SOP.

  • ATTACHMENTS

Not Applicable.

  • PROCEDURE
    • 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.
  • REFERENCES:

In House

  • ABBREVIATIONS

QC       – Quality Control.

QA      – Quality Assurance

RSD     – Relative Standard Deviation

  • DISTRIBUTION LIST

          Quality Assurance

Quality Control

10.0   HISTORY OF REVISION:

Version  No. Effective Date  Reason for Revision

 

 

 

SOPs