sop for approval and rejection of packaging materials

1.0. OBJECTIVE:

The objective of this SOP is:
1.1 To describe the procedure for Approval and Rejection of Packaging Material.

2.0. RESPONSIBILITY:

2.1 The Chemist / Officer – Quality Control Packaging shall be:
2.1.1. Responsible for ensuring proper documentation of sampling and adequate number of quantity sampled.
2.1.2. Responsible for carrying out analysis of packing material (s) accurately & precisely by following

specification and standard testing procedure.
2.1.3. Responsible for maintaining the Packaging Material Register.
2.1.4. Responsible for preserving the reserve sample along with Analytical Test Report.
2.1.5. Responsible for recording the correct results in the Analytical Test Report for every PM in a stipulated time.

2.2 The Executive – Quality Assurance shall be:
2.1.1 Responsible for verify and review of the recorded results and of the ensuring the results are within the standard limits.
2.1.2 Responsible for updating the document as per regulatory requirement
2.1.3 Responsible for ensuring all laboratory instruments are calibrated and working satisfactorily.
2.1.4 Responsible for final disposition of material under consultation with Head – QA/QC.
2.1.5 Responsible for imparting training to sub-ordinates including Good Laboratory Practice.

3.0. ACCOUNTABILITY:

Executive – Quality Assurance

4.0. PROCEDURE:

4.1. The sampling of the packaging material shall be carried out as per the SOP
4.2. Before starting the analysis take out Standards and Results Sheet from Respective Product File and take out photocopy

and get it issued from Sectional Head by signing the space provided.
4.3. The sampled items shall be analysed as per respective laid down specifications and general test procedure.

The results shall be recorded in the Analytical Test Report and compare for its limits.
4.4. Prepare Certificate Of Analysis in case the material is being used, to the Regulated Market. (Refer Annexure – 1).
4.5. Then compile the results along with Sampler’s Remark and keep one Reserve Sample for printed packaging material

by affixing Reserve Sample Label on non-printed part (Refer Annexure – 2 for Reserve Sample Label).
4.6. The Goods Receipt Note (GRN) along with complete analytical report shall be checked thoroughly by another person.
4.7. Then this complete report shall be forwarded to the Head – QA or Executive – QA for further disposition (Approval / Rejection).
4.8. The results are not within the specified limits and standards, the material shall be rejected
4.9. If the material is rejected, the Material Rejection Note (Refer Annexure – 3) shall be prepared and get it approved from

Head – Plant Operation, Head – QA / QC.
4.10. If all parameters found within the prescribed range Executive or Head – QA shall approve the Analytical Test Reports and GRN.
4.11. The report with regards to the disposition of the said consignment is then made & the status label as whether it is

APPROVED or REJECTED (Refer Annexure – 2) shall be generated by using the computer System.
4.12. Affix the duly signed APPROVED / REJECTED label to the consignment.
4.13. Each approved pack of packing material shall be identified by affixing the small green label (Refer Annexure – 2)

having the A.R. No. for identity of the Consignment.
4.14. Forward the approved / rejected copies of GRN to Warehouse for further actions.
4.15. File the entire report along with Quality Control GRN Copy.
4.16. Then Warehouse personnel shall shift the Approved / Rejected material in the designated areas.

4.17. The rejected consignment shall be shifted to the designated Rejected Areas under lock and Key.
4.18. The approved material is then used for Production as per requirement.
4.19. The shelf life of each individual packaging material is being work out, on the basis of stability study of these materials.

Till that time the shelf life of packing materials is three years from the date of release of material.

5.0. REASON FOR REVISION:

Revised for more effectiveness in Approval and rejection procedure and shelf life period is incorporated.

6.0 TRAINING:

Trainer — Executive – Quality Assurance
Trainees — Officers / Assistants – Quality Control Packaging
Period — One day

7.0 DISTRIBUTION:

Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : File Copy for Packaging Laboratory
Certified Copy No. 3 : Head – Plant Operation.
Original Copy : Head – quality assurance.

sop for approval and rejection of packaging materials

ANNEXURE – 1

FORMAT FOR CERTIFICATE OF ANALYSIS

ANNEXURE – 2

FORMAT FOR APPROVED

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