SOP for Intimation to QC for retesting

1.0 OBJECTIVE
To describe the procedure for intimation of re-testing of raw and packaging materials as it is necessary to retest and reconfirm the properties and potencies of all released materials in stock as per predetermined standards after certain period of time.

2.0 SCOPE
This procedure is applicable for re-testing of balance stocks of all released raw and packaging materials.

3.0 RESPONSIBILITY
3.1 Warehouse officer shall be responsible for daily monitoring and intimation of re-testing and expired raw and packaging materials.
3.2 Warehouse in-charge shall be responsible for effective implementation of the procedure.
3.3 QC chemist shall be responsible to carry out the sampling / testing of materials.

4.0 ACCOUNTABILITY
4.1 Manager, Warehouse

5.0 PRECAUTION
5.1 Check retest date of all raw and packaging materials from Inventory Management System on 1st week of every month for submission of retest request form to QC Dept.
5.2 Materials to be retest shall be transferred to warehouse from production department through ‘Material Return Note’ before due date of retesting.
5.3 Ensure daily checking of retest date and expiry date of all raw and packaging materials from Inventory Management System.

6.0 PROCEDURE
6.1 Frequency of Re-Testing
6.1.1 Materials shall be tested as per the frequency mentioned by the QC Dept.
6.2 Intimation and Sampling
6.2.1 Warehouse officer shall send request for retest (FRM No.: FWH/021) to QC dept.of raw and packaging materials due for re-testing at one month before of assigned retest date by the QC department.
6.2.2 After receipt of ‘Request for retest from Warehouse’ (FRM No.: FWH/021) for retesting, QC shall plan and arrange for sampling so that the material shall be retested on or before the due date.
6.2.3 During retesting of the materials (before expiry of the retest period) the under test material will be kept in the approved material area.
6.2.4 After completion of QC analysis, QC shall give duly signed copies of ‘Request for retest from Warehouse’ to warehouse for Released / Rejected materials. In case of rejected material, QC shall also inform to warehouse and Procurement Department through rejection memo.
6.2.5 Warehouse officer shall entry in Inventory Management System to deduct sample quantity from stock as per request for retest (FRM No.: FWH/021) returned from QC dept.
6.2.6 In case of approved material, QC officer shall affix ‘Released’ label (FRM No.: FQC/002) in a cascading manners and the material will be remained in the approved material area. Warehouse officer shall update the status of material (retest date and A.R.No.) in Inventory Management System as per request for retest (FRM No.: FWH/021) returned from QC.
6.2.7 For rejected material, QC officer shall affix ‘Rejected’ label (FRM No.: FQC/003) on each pack / container .Warehouse officer shall make the necessary entries in ‘Rejected materials Record’ (FRM No.: FWH/010) and transferred material to rejected area under lock and key.
6.2.8 Warehouse officer shall update the status of rejected materials in Inventory Management System through stock adjustment memo (Written Off) as per rejection memo.
6.2.9 If any time any label is peeled off from the container / bag, warehouse in consultation with QC should ascertain the identity and batch details and QC issue & affix the required label on container.
6.3 Control on Materials (on due date of retest or expiry materials)
6.3.1 Check retest date and expiry date of all raw and packaging materials daily from Inventory Management System to ensure that no material kept in approved storage area after due date of retest or expiry.
6.3.2 After completion of checking, warehouse officer shall make entries in the “Retesting and expired material monitoring record (FRM No.: FWH/045)”.
6.3.3 On the due date of retesting, Warehouse officer shall affix the ‘Quarantine’ label (FRM No.: FWH/004) on the containers and transfer the material from approved area to Quarantine area.
6.3.4 On the due date of expiry, Warehouse officer shall isolate that material from Approved storage area with proper status label until the material gets ‘Reject’ label from QC Dept. After affixing ‘Rejected’ label, Warehouse officer shall transfer material to rejected material store under lock and key.

Share This Post

Related Articles

© 2025 Pharmaceuticals Index. All rights reserved.