SOP for Retesting Schedule of Packaging Material

1.0 OBJECTIVE

To ensure compliance with the specification for approved primary packaging material at regular interval during storage.

2.0 SCOPE

This procedure is applicable for approved primary packaging material, lying in the Packaging Material store.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Generate a Retesting List through SAP System with Inspection lot origin 09 in QA33 as per Listed Annexur-I.
5.2 As per retesting list respective P.M. status will be changed from Unrestricted to Quality inspection stock through SAP System.
5.3 Sample the material for retesting as per the list generated by the system and verify origin against their record.
5.4 Affix blue color “UNDER RETEST” label on each Box and Rolls having following details and cross out “Approved” label with the marker on all boxes.
Name of Material:
A.R. No.:
Sample By:            Date:
5.5 Carry out the testing as per the test mentioned in the following table for respective packaging materials.

Sr. No.	Packaging material	Test
01	Aluminium Foils	Description, Pin holes, size and thickness
02	Vials and Ampoules	Description, chemical resistance(powdered glass test)
03	Plastic caps (Nikoran tab)	Description, Loss on drying of silica
04	PVC/PVDC foil	Description, size and thickness
05	Rubber stopper	Description, pH of aqueous solution, biological test
06	Silica bag	Description, loss on drying

Note: Check the Physical description of all materials during retesting

5.6 Prepare Retest report, Record results in SAP System & get it signed by Quality Control Incharge.
5.7 On completion of testing the Q.C. Incharge will change the status of material in SAP System.
1. Accepted. 3. Part Qty. Rejected.
2. Rejected. 4. Fails.
5.8 Keep the record of retesting in a separate file.
5.9 On approval of material affix “APPROVED” label with the new retesting date on respective Boxes and Rolls.
5.10 If the material is rejected, affix “REJECTED” label on respective Boxes and Rolls.

Related: SOP for Handling of Rejected Packing Materials

6.0 ABBREVIATIONS

6.1 PVC = Poly vinyl chloride
6.2 PVDC = Polyvinlidene chloride
6.3 A.R. No = Analytical Report Number

Annexure-I 

PACKAGING MATERIAL RETESTING SCHEDULE

SR.NO.	NAME OF MATERIAL	RETESTING  PERIOD
01	Plain foil	1 year
02	Printed foil	1 year
03	PVC film	1 year
04	PVDC film	1 year
05	Vials	1 year
06	Ampoules	1 year
07	Plastic caps	6 month
08	Rubber stopper	1 year
09	Silica bag	6 month

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