Back to Library·QCS-005 Batch Review & COA
Quality Control
Intermediate
Last updated: Jul 8, 2026
Official signed PDF · SIPL/QCS/005
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QCS-005 Batch Review & COA

  • PURPOSE

  • To define a procedure for review of manufactured batches and issuance of COA.

  • SCOPE

  • This SOP applies to all material which is tested for quality.

  • REFERENCE(S) & ATTACHMENTS

  • References

    • In-house

  • Attachments

    • Attachment- I : COA Format SIPL/QCS/005/F01/00

    • Attachment- II : BMR Format SIPL/QCS/005/F02/00

  • RESPONSIBILITY

  • QC Department Head: To prepare the SOP and its scope.

  • QA Head: To approve the SOP and to ensure implementation.

  • DISTRIBUTION

  • Quality Assurance

  • Quality Control

  • DEFINITION(S) & ABBREVIATION(S)

  • Definitions

    • Nil

  • Abbreviations

    • COA: Certificate of Analysis

    • BMR: Batch Manufacturing Record

  • PROCEDURE

  • Batch Review:

    • All manufactured batches shall be reviewed by a QA/QC Authorized Person.

    • The reviewer shall ensure that all the procedures necessary to provide assurance of product quality are in place and effective before a product is released.

    • The reviewer shall assess manufacturing and environmental conditions, and confirm that the results of in-process testing are in compliance with requirements. All records shall also be checked by the reviewer before clearing the batch.

    • In case of any deviation, the reviewer shall check the severity and final impact of the deviation on the quality of the product. Considering the above, the final decision on batch clearance shall rest with the QA Head.

  • Issuance of COA:

    • The COA shall be issued once the material is approved by Quality.

    • The COA shall contain general testing parameters relevant to the product.

    • The COA's general format, header, and footer shall be fixed. Testing parameters and other information shall change as per customer requirement.

  • REVISION HISTORY

+----------------+----------------+----------------+----------------+----------------+----------------+ | Revision No. | 00 | Effective | | CC No. | | | | | Date | | | | +----------------+----------------+----------------+----------------+----------------+----------------+ | Details of revision: New SOP | +-----------------------------------------------------------------------------------------------------+

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