SOP on Approval or Rejection of Packing Material

The purpose of this SOP is to lay down the procedure for Approval or Rejection of Packaging materials.

This SOP is applicable for Approval or Rejection of Packaging Materials in Quality Control Department at manufacturing facility of Pharmaceutical Industry.   

PROCEDURE :

Before initiating other tests, compare with standard Shade card in case of printed Packaging Materials and match specimen proof.

Analyze the Packaging materials as per Packaging Material “SPECIFICATIONS” and “STANDARD TEST PROCEDURES”. Record the observations & results of Analysis in Record of Analysis.

After completion of Analysis, if it complies with the specifications approved the materials and   intimate warehouse through intimation slip.

Affix the printed and signed “APPROVED” labels taken from SAP system or manual on each containers of packaging material over “UNDERTEST” labels.

Confirm the rejection, if Packaging materials does not comply with Specification and report to Head QC regarding non-compliance of materials.

If the packing materials are not satisfactory in physical condition of materials or container which was observed during sampling, report to Head QC and if justified “REJECT” that particular container or consignment.

If online rejection done at the time of packaging, Packing officer intimate to HOD QC by online rejection format to Head of Quality Control department through QA Department.

QC Chemist / Officer Signs on “REJECTED” labels and affix these labels on each container of rejected packaging material over “UNDERTEST” label. Ensure that the containers of rejected packaging materials are transferred to “Rejected materials storage area”

TRAINING:

As per SOP on Employee Training

DISTRIBUTION:

As per SOP ON SOP

ANNEXURE:

Annexure I : Rejection Note of Packing Material

REFERENCES:

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