EVALUASI PENERAPAN KUALIFIKASI VALIDASI MENURUT CPOB INDUSTRI FARMASI PT OTSUKA INDONESIA

Background: The pharmaceutical industry is a business entity that has the authority to produce drugs or medicinal substances on a large scale which officially has permission from the Minister of Health. In order to achieve good product quality, there are guidelines that need to be considered, namely (CPOB) Good Medicine Manufacturing Methods.
Objective: To find out whether validation qualifications are implemented at PT Otsuka Indonesia is in accordance with CPOB.
Method: Qualitative descriptive is the research method used in this research. Qualitative methods are used so that in research, researchers obtain actual data and correspond to what is actually being researched without reducing or exaggerating the data obtained.
Results and Conclusions: From the results of the research carried out, it can be concluded that conformity to CPOB standards means that the validation qualification stages at PT Otsuka Indonesia towards CPOB is almost perfect because only one provision is not appropriate, namely at the qualification stage in the Facroty Acceptance Testing (FAT) process. To replace the FAT stage, it has been replaced with the SAT site acceptance testing stage which is carried out at PT Otsuka Indonesia.