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/Executive3.2 Checking: Executive /Manager
4.0 ACCOUNTABILITY
Head of the Department5.0 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
|
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
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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