| dc.description.abstract | Objective : Pharmacist Professional Work Practice (PKPA) in the pharmaceutical
industry is carried out with an effort to improve the insights, skills, and
understanding of prospective pharmacists regarding the roles, duties, and
responsibilities of pharmacists in the production process, quality control, and
quality assurance in the pharmaceutical industry, especially in the application of
Good Manufacturing Practices (CPOB) in accordance with applicable regulations.
Methods: PKPA implementation is carried out through an observational and
participatory approach. Students are placed directly in the Quality Assurance (QA)
unit and follow the entire process flow related to the quality management system,
starting from the inspection of raw materials, production processes, packaging,
validation, documentation, to self-inspection. During the practice, students were
actively involved in internal audit activities, monitoring the production process,
evaluating laboratory test results, as well as managing complaints and product
recalls. In addition, students also gained a comprehensive understanding of the
organisational structure of pharmaceutical companies, the functions of each
department, and coordination between work units in order to ensure the quality of
pharmaceutical products.
Results : The implementation of PKPA shows that PT Pharos Indonesia has
implemented a quality management system optimally in accordance with the latest
edition of the CPOB standard. The implementation of the quality system in the
company includes aspects of personnel, production facilities, equipment,
sanitation, and documentation, as well as procedures that support the quality
assurance of drug products. The role of pharmacists in pharmaceutical companies
has proven to be crucial in ensuring the quality, safety, and efficacy of drugs
through direct involvement in all stages of the production process and quality
control. In addition, students get a real picture of the problems faced in the
production process of the pharmaceutical industry and how solutions are applied
systematically and according to regulations.
Conclusion : The implementation of this PKPA is that the pharmacist profession
has an important responsibility in ensuring the implementation of an effective and
sustainable pharmaceutical industry quality system, in accordance with the
principles of CPOB. Through direct involvement in the production process and
quality assurance, pharmacists are able to ensure that every pharmaceutical
product produced meets the established quality standards and is safe for use by the
public. | en_US |
