SOP on testing and approval / rejection of packaging material
Testing and approval/rejection of packaging material
Objective:
To lay down a procedure for testing and approval/rejection of packaging materials.
Scope:
This sop is applicable for testing and approval/rejection packaging materials
Responsibility:
QC –Chemist or above shall be responsible for testing of packaging materials
QC-Executive / Nominee shall be responsible for reviewing of worksheet.
Accountability:
Head – QC shall be accountable for compliance of SOP.
Procedure:
Testing of packaging material:
The sampling of the packaging material shall be carried out by Quality Control chemist/officer
Perform the analysis of packaging material as per respective specification and general test procedure and record the raw data in respective worksheet.
If the tests result does not comply with specification, the same shall be informed to Head –QC for further action.
Review of results and approval/rejection of Packaging Material:
Executive QC or nominee shall review the results against laid down specifications.
The head QC shall be responsible for final approval.
If the material is approved, generate “APPROVED” labels for each container and affix them on each box/bag over the “UNDER TEST” label in such a manner that the entire “UNDER TEST” label is completely covered by the “APPROVED” label.
If material is rejected, generate “REJECTED” labels and affix on each box/bag over the “UNDER TEST” label in such a manner that the entire “UNDER TEST” label is completely covered by the “REJECTED” label.
For Primary Packaging Material and Printed Sticker labels: Generate ‘2n+1’ labels of “APPROVED” or “REJECTED” for each A.R. No. Affix one label on the “Sampler’s Report of packing Material” for reference and remaining labels on the “UNDER TEST” label as well as in the core of each roll. Note: n is no. of rolls.
For secondary and tertiary Packaging Material: Generate ‘n+1’ labels of “APPROVED” or “REJECTED” for each A.R. No. Affix one label on the “Sampler’s Report of packing Material” as per Annexure No. A02 for reference and remaining labels on “UNDER TEST” label of each pack. Note: n is no. of packs.
Fill in the necessary details of quantity released / rejected and signature of Authorized Quality Control person in goods received note (GRN) . Retain QC copy (2nd copy of goods received note) and return rest of the copies duly signed, to warehouse.
Fill in the necessary details like status for approved / rejected, signature and date in PM Register.
For Other Pharma Related Post and Updates Click Here
List of annexure / Formats:
S.No. | Format Title |
1 | Worksheet of shipper |
2 | Worksheet of Foil |
3 | Worksheet of carton |
4 | Worksheet of sticker label |
5 | Worksheet of Bopp Tape |
6 | Worksheet of Aluminium Seal |
7 | Worksheet of measuring cup |
8 | Worksheet of HDPE Bottle |
9 | Worksheet of Catch Cover |
10 | Worksheet of Leaflet |
11 | Worksheet of Plain Alu – Alu Foil |
12 | Worksheet of PVC Flim |
13 | Worksheet of PVC Polybag |
14 | Worksheet of PVDC Film |
15 | Worksheet of Rubber Stopper |
16 | Worksheet of Screw Cap |
17 | Worksheet of Blister Foil |
18 | Worksheet of Glass vial |
Abbreviation:
QC: Quality Control
SOP: Standard Operating Procedure
A.R.No.: Analytical reference Number
GSM: Grammage
BOPP: Biaxialy oriented polypropylene
PVC: polyvinyl chloride
PVDC : polyvinylidene chloride
VMCH: Vinyl Methyl Cyclohexane
OPA: Oriented polyamide