SOP For physical inspection of containers of sterile raw material is described in this post which you can follow in the section of the Quality Assurance Department
OBJECTIVE
This procedure has been established to provide the guideline for inspection of sterile raw material container before transferring to the sterile area.
SCOPE
This SOP applies to QA, QC (Micro section) and Production Department (Sterile area section).
RESPONSIBILTY
Q.A Officer
ACCOUNTABILITY
Manager Quality Assurance
PROCEDURE
Dedust the outer packing /container with lint free duster / vacuum cleaner.
Transfer the container to quarantine area.
Check the information /specifications on the original label pasted on the outer packing if applicable.
Confirm the vendor from “Approved Vendor List”. Vendor must be approved.
Compare the information /specifications given on the original label pasted on the container with the ones mentioned on Certificate of Analysis / Pouch vial. If any contradictory information is observed, inform Incharge Quality Assurance/Quality Control.
Check the expiry date and manufacturing date. In case of expiry date less than that of product to be manufactured, immediately inform the Incharge Quality Assurance and Manager warehouse. Expiry date should preferably be at least about 6 months more than that of the product to be manufactured.
Information /specifications should be same on both inner container and outer packing.
Check the sealing for any damage/leakage or pinholes on the surfaces of container carefully.
Container sealing should be satisfactory and intact. Packing should be neat, clean and free from contamination, dust or rust.