Preparation and Issue of certificate of analysis

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 with the QC Manager or his/her 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.

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