1.0 PURPOSE
To describe the procedure for batch release.
2.0 SCOPE
2.1 This procedure is applicable to release APIs and Intermediates.
3.0 RESPONSIBILITY
3.1 Production Department
3.2 Quality Control Department
4.0 ACCOUNTABILITY
4.1 Quality Assurance Department (QA)
5.0 PROCEDURE
5.1 Production department shall send the completed Batch Production and Control Record (BPCR) to QA department.
5.2 QA shall review the BPCR as per the BPCR review check list, annexure – I.
5.3 Quality control shall send the Analytical Test Report (ATR) after completion of the analysis to QA department.
5.4 QA shall review the analytical test report as per the check list,annexure – II.
5.6 Observations during review of BPCR and Analytical Test Report shall be informed to the respective department head or his deputy.
5.7 On receipt of the justifications from the respective departments, QA shall review and release the batch by sending the release and transfer slip to the production department Annexure –III.
5.8 The reviewer shall file the BPCR & ATR in the respective product wise files.
END OF DOCUMENT
Batch release, production
