Standard Operating Procedure for Approval and Rejection of Raw / Packing Materials

1. OBJECTIVE:

To lay down a procedure for approval and rejection of raw / packing materials.

• SCOPE:

This procedure is applicable for procedure for approval and rejection of raw/ packing materials.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager

•  PROCEDURE:
  • Sampling of raw materials should be done as per reference SOP “Sampling of Raw Material.
  • On receipt of raw material samples in Quality Control Department along with Sample advice note, COA of supplier (if available) and Sampling observation sheet, the Chemist shall check the following:
  • Label details on the samples to match with those on Sampling advice note or MRN and COA of supplier (if available).
  • Sampling observation Sheet.
  • In case of any discrepancies, clarify with QC Manager.
  • Ensure that the samples and documents are placed properly in trays meant for the purpose.
  • The Chemist shall take up the sample for analysis as per current specifications and Analytical Methods. Any specific non-conformance shall be brought to the attention of QA and enter the results in the analytical report. Immediately on completion of the analysis, submit the completed Analytical report duly signed to QC Manager.
  • QC Manager shall check the analytical data and compliance of material as per specifications and shall clear the material if it complies. In case the material does not comply with specifications, reject the material after informing to QA Manager.
  • QC Manager / QA Manager shall certify the approval / rejection of raw material by signing the documents.
  • Approved / Rejected labels will be prepared by QC chemist as per reference SOP.
  • QC Chemist shall sign the approved / rejected labels. Match the details like name of the material, MRN No., batch number on the container label with details on approved / rejected label. Affix the approved / rejected label on each container in such a manner that the word “UNDER TEST” on the label is completely overlapped and the name and MRN No. on the “UNDER TEST” labels are visible.
  • Take care that the name and MRN/GRN number on the under test label are visible.
  • After finishing the Analysis, enter the results in Raw Material Entry Register & take usage decision for approved / rejected. After approval / Rejection Paste the Approved / Rejected Labels on the under test label of the container.
• TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the QC departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department

• REFERENCES:

In-House