Quality Control of Pharmaceutical Products at PT Meprofarm

Abstract

Established in 1973 by Ir. Wanne Mardiwidyo, PT Meprofarm is an Indonesian pharmaceutical company based in Bandung that always prioritizes achieving quality in producing products. Meprofarm has 2 main production facilities which are MEPRO-1 and MEPRO-2. MEPRO-1 focuses on producing solid dosage forms of non-beta lactam, beta lactam penicillin, and beta lactam cephalosporin. Meanwhile, MEPRO-2 produces oral liquid, external liquid, and semisolid dosage forms of non-beta lactamase. The Quality Control (QC) department is supervised by the Quality Operation under the Manufacturing Operations. As an essential part of the good manufacturing practices (GMP), QC functions to ensure that every aspect of the drug manufacturing process, starting from the raw material until the finished product meets the safety, efficacy, and quality standards of medicines. During the internship period, the works assigned were given by the Raw and Packaging Materials, Stability, and Finished Good (Microbiology) divisions. In a way to ensure the quality of drugs from its raw materials until the finished products, QC has the responsibility to create procedures and specifications to perform the tests and evaluation, also making reports of the test results as evidence. The scope of works given in the internship were revising and updating documents of Starting Material Specification and Starting Material Test Method according to the current Pharmacopeias and certificate of analysis (CoA), revising and updating the SOPs of climatic chamber devices and personnel limitation access into bilingual format, creating documents of Stability Study Protocol and Stability Study Report, and processing raw data and creating trend line graph then making the trend analysis report of environmental monitoring for microbial contamination. All the works given were performed well and to conclude, the QC department has implemented the GMP in all aspects of their work and environment.