Get the latest updates from us for free
Android App

SOP for Retesting Schedule of Packaging Material


Standard operating procedure to schedule the retesting of the Packaging Material.

1.0  OBJECTIVE

       To ensure compliance of 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 colour “UNDER RETEST” label on each Box and Rolls having following details and cross out “Approved” label with 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 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 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 new retesting date on respective Boxes and Rolls.          
5.10  If material is rejected, affix “REJECTED” label on respective Boxes and Rolls.

RelatedSOP 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
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


Be the first to comment!

Post a Comment