Procedures for Resampling and Retesting

1) Purpose

The purpose of this SOP is to provide clear guidelines for resampling and retesting materials or products when initial results are questionable or invalidated to ensure the accuracy and reliability of test results.

2) Scope

This SOP applies to all instances where initial test results for raw materials, in-process materials, or finished products are questionable or invalidated within the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for implementing and following this SOP. All personnel involved in resampling and retesting must be adequately trained on this procedure.

4) Procedure

1. Initiation of Resampling and Retesting:
   1. Identify the need for resampling and retesting based on initial test results that are questionable or invalidated.
   2. Obtain approval from the QC manager or designated authority before proceeding.
2. Resampling Process:
   1. Follow the same sampling procedure outlined in the initial sampling SOP to ensure consistency.
   2. Collect new samples from the same batch or lot of material or product.
   3. Label the new samples appropriately with details including batch number, date, and reason for resampling.
3. Retesting Process:
   1. Transfer the resampled material to the laboratory under suitable conditions.
   2. Perform the same tests as were conducted initially, following the same methods and procedures.
   3. Document all retesting activities and compare results with initial tests.
4. Review and Documentation:
   1. Review the results of the retesting to determine if they are consistent with initial findings.
   2. If discrepancies remain, investigate potential causes and document findings.
   3. Record all details of the resampling and retesting process in the appropriate logbooks and forms.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Initial Test Results, Resampling Forms, Retesting Logbooks, and Investigation Reports

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0