| dc.description.abstract | Objective: This Professional Pharmacist Practice was conducted to observe firsthand the roles, functions, and responsibilities of a pharmacist in the pharmaceutical industry and to understand the implementation of Good Manufacturing Practices (GMP) at PT. Abbott Indonesia. This activity aimed to equip prospective pharmacists with sufficient practical insights, knowledge, and experience regarding pharmaceutical work in the industry through the application of GMP.
Methods: The Professional Pharmacist Practice (PKPA) in the Pharmaceutical Industry at PT. Abbott Indonesia was carried out from June 3 to July 31, 2024. The PKPA activities at PT. Abbott Indonesia were conducted by the PKPA student in the Quality Assurance Operations department, specifically focusing on batch record control and retained sample management.
Results: The tasks of QA Operations include ensuring assurance and compliance of product quality, daily inspections, internal audits, QA files management, retained sample management, and batch record release. One of the key tasks of QA Operations is batch record release. QA Operations is responsible for compiling batch records, reviewing batch records, and approving batch records. The preparation of documents, done manually for operational activities, includes a numbering sequence for each document, and storage periods are differentiated based on document type. At PT. Abbott Indonesia, the storage of raw materials, packaging, retained samples, and finished samples is managed by QA Operations. Retained samples are stored in a dedicated room within the warehouse. QA Operations also plays a role in conducting inspections, internal audits, and investigations.
Conclusion: PT. Abbott Indonesia has effectively implemented GMP aspects in every aspect and sequence of its production processes. | en_US |
