QA Responsibilities in Injectable Area

The purpose is to provide the guidelines for the QA inspector responsible for parenteral facility. 

Area QAI (quality assurance inspector) is responsible for following the procedure. The quality assurance (QA) manager is responsible for SOP compliance. 

The QAI will perform the following activities. In case of any deviation, the QAI will inform the QA manager and area manager to ensure that corrective actions are taken. 

QAI will check the particulate of the manufacturing area using laser particulate counter, per plant SOP (provide number). 

QAI will monitor the results of pressure differentials, temperature, and humidity obtained from the control room daily before starting the manufacturing process in the area for comparison of results with the standard provided for each area. They should be within limits. Whenever any operation such as manufacturing or filling starts, QAI will fill an inspection start-up checklist and give release for manufacturing or packaging. See attachment no. 1700.30(A), 1700.30(B), and 1700.30(C). 

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