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Resposibilities of GMP Quality Units





Responsibilities of Quality units include:



  • Releasing or rejecting APIs and intermediates.


  • Establishment of a system to release or reject raw materials, intermediates, labeling or packaging materials.


  • Reviewing the records of steps of the process before release of API for distribution.


  • Investigating and Resolving the critical deviations.


  • Approving all specifications and master production instructions.


  • Approving all procedures involved in maintaining quality of intermediates or APIs.


  • Performing internal audits/inspections.


  • Approving intermediate and API contract manufacturers


  • Approving potential changes for quality.


  • Reviewing and approving validation protocols and reports.


  • Investigating and resolving quality related complaints .


  • Ensuring the maintainence and calibration of critical equipments.


  • Ensuring the proper testing, documentation and reporting of the results.


  • Ensuring the stability data to support retest or expiry dates and storage conditions on APIs /intermediates, when required.


  • Performing Quality reviews.


In order to check the ongoing activities


  • Internal audits are performed to verify the compliance with the principles of GMP for APIs. Audit findings are investigated and documented and then brought to the attention of responsible management of the firm.


  • Regular quality reviews are conducted in order to verify consistency of the process. The reviews include the critical in-process control and critical API test results, review of the batches that have failed to meet established requirements, deviations and related investigations, changes in the analytical processes and results of the stability monitoring program.



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