Quality Assurance Process Operations at PT. Kalbio Global Medika

Abstract

The production of pharmaceuticals involves intricate procedures that carry a great deal of risk which can compromise the final product's quality. Moreover, the manufacturing of biologics must adhere to the laws, statutes, regulations, and guidelines. Thus, the Quality Assurance (QA) department is required to ensure and guarantee that the standards required by the consumers and the law are met accordingly. This can be achieved through providing documents and evidence which includes every deliberate action taken to ensure that the process is carried out properly with all the required data generated, recorded, and reported in accordance with the relevant regulatory requirements. The process operation quality assurance division is responsible for batch release, PQR, cell bank, deviation, and production oversight. Before performing any tasks, every employee is required to read the SOP and sign the training form as proof of the training provided by the company. Batch record handover was performed by ensuring that every entry in the batch record was filled accordingly, signed, and contained original data (print outs, test result photos, etc.). PQR was also generated for each batch where defects, deviations, process time, yield, reconciliation, actual weight, and other critical variables were recorded. The QA department is also responsible for deviation reports which require evidence of Corrective Action and Preventive Action (CAPA) execution as well as routine follow up. Certificates of Analysis (COA) were also generated which is a summary of test results required for the batch identification as well as to ensure the quality and purity of the product.