Follow
Objective: To lay down the procedure for preparation of certificate of analysis for product/material of Quality Control Department.
Scope: This SOP is applicable for Quality Control Departments of (Company Name).
Responsibility:
1. Each individual in the laboratory is responsible for carrying out the procedure.
2. Overall responsibility for training, implementation & follow-up shall be with the QC Manager or his nominee.
Precautions: Certificate of Analysis must be prepared in the approved format.
Procedure:
=>> Certificate of analysis for Raw Materials and Primary Packaging Materials shall be prepared as per Annexure-I.
=>> For secondary and tertiary packaging materials, no Certificate of analysis shall be prepared during batch release. But, shall be prepared as per Annexure-I if requested by any customer.
=>> Certificate of analysis for Finished Products shall be prepared as per Annexure-II.
=>> Head of Quality or his designee shall approve each individual certificate of analysis prior to issue.
=>> Certificate of analysis shall include the following minimum information
=>> Name of the product / material
=>> Batch number/ Lot number/ R. No.
=>> Date of manufacturing
=>> Expiry date (or retest date for drug substances)
=>> Quality Control reference number
=>> Date of analysis (Date of analysis should be considered as the completion date of analysis)
=>> Release date (For Raw Materials only)
=>> Test Parameters and Specification
=>> Results against specification
=>> Conclusion, remarks or comment
=>> Date of preparation, review and approval (based on customer requirement, the name & designation of prepared by, reviewed/checked by and approved by shall be mentioned).
=>> As per customer requirement any change of this format can be done to include additional information.
=>> COA shall be issued and approved only after completion of testing product/material by QC.
=>> In case, the concerned batch is not meeting with the requirement of the specification, the batch shall be rejected with mentioning “Rejected” under conclusion and a note should be given under remarks in the COA.
=>> An original copy of a COA can be re-issued due to correction or inclusion of test results or to update as per current specification or as per customer requirement. In this case “Re-issued” shall be mentioned with the date in the COA.
