SOP FOR RETESTING OF RAW MATERIAL

1. OBJECTIVE:

1. To lay down the procedure for Retesting of Material.

2. SCOPE: 

1. This procedure is applicable for the Retesting of Material .

3. RESPONSIBILITY:

1. Warehouse Personnel is responsible Intimation to QC and follow procedure as per the procedure mentioned in this SOP.  

2. Quality Control Officer/ executive are responsible for testing and follow procedure as per the procedure mentioned in this SOP. 

3. QC Head is responsible for Approval & release and implementation and compliance of the procedure as per this SOP.

4. ABBREVIATIONS

1. SOP    :    Standard Operating Procedure

2. QC    :    Quality Control

3. A.R. Number:    Analytical Report Number

4. STP    :    Standard Testing Procedure

5. PROCEDURE: 

1. Retest Raw Materials Sampling:

1. All active raw materials and excipients shall be retested after one year from the date of approval.

2. Warehouse persons shall make an intimation note 15 days before schedule of retest date to Quality control for retesting of materials.

3. After receiving intimation note from store enter the details in retest In-ward register. 

4. Sampling of retest samples should be done as per SOP No.- QC011

5. The sample quantity shall be the half of the sample quantity as mentioned in SOP called “Raw Material Sample Quantity”. There is no necessity to keep retain sample for Retest sample.

2. Testing And Release:

1. Retesting is performed for critical tests like description, pH, water / LOD, assay, etc.

2. During the analysis the test results shall be entered in the analytical test data sheets as per respective material.

3. But if the material is not meeting with the specification then he / she shall inform to QC. In charge Immediately & follow the SOP called “Reporting out of Specification Results”. 

4. After getting the Approved / Rejected status of the materials, Quality Control shall affix the Approved/ Rejected label, covering the existing label.

5. Any raw material shall be retested not more than twice and after that the material shall be retested only before use. During that period raw materials shall be transferred to quarantine area.