SOP for Retesting Schedule of Packaging Material

Objective

To ensure compliance of specifications for approved primary packaging material at regular intervals during storage.

Scope

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

Responsibility

Doing: Technical Assistant/Executive

Checking: Executive /Manager

Accountability

Head of the Department

Procedure

• Generate a Retesting List through the SAP System with Inspection lot origin as per Listed Annexur-I.
• As per the retesting list respective P.M. status will be changed from Unrestricted to Quality inspection stock through the SAP System.
• Sample the material for retesting as per the list generated by the System and verify the origin against their record.
• Affix the blue color “UNDER RETEST” label on each Box and Rolls having the following details and cross out the “Approved” label with a marker on all boxes.

1. Name of Material:
2. A.R. No.:
3. Sample By: 
4.  Date:

• 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	Description, Loss on drying of silica
04	PVC/PVDC foil	Description, siz,e and thickness
05	Rubber stopper	Description, pH of aqueous solution, biological test
06	Silica bag	Description, loss on drying

Note: Check Pthe hysical description of all materials during retesting

• Prepare Retest report, Record results in SAP System & get it signed by Quality Control Incharge.
• On completion of testing the Q. C. Incharge will change the status of the material in the SAP System.

1. Accepted. 
2. Rejected.
3. Part Qty. Rejected.
4. Fails.

• Keep the record of retesting in a separate file.
• On approval of material affix the “APPROVED” label with the new retesting date on respective Boxes and Rolls.
• If the material is rejected, affix a “REJECTED” label on respective Boxes and Rolls.

ABBREVIATIONS

PVC: Polyvinyl chloride

PVDC: Polyvinlidene chloride

A.R. No = Analytical Report Number

ANNEXURE

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 (Nikoran tablet)	6 months
08	Rubber stopper	1 year
09	Silica bag	6 months

REVISION HISTORY

Nil

ALSO READ: SOP for Retesting Schedule of Raw Material