| dc.description.abstract | Background: The pharmaceutical industry is a licensed business entity that
engages in the production of medicines. To ensure that the quality of medicines
produced meets the requirements and is suitable for their intended use, Good
Manufacturing Practices (GMP) are required, which serve as a reference for every
pharmaceutical industry in the production of medicines. In order for the medicines
produced to be distributed, they must first obtain a distribution licence. A marketing
authorisation is a form of registration approval for distribution in Indonesia.
Objective: This report aims to determine the roles, functions, and responsibilities
of pharmacists in the pharmaceutical industry, specifically in the Business
Development department at PT. Novell Pharmaceutical Laboratories, as well as to
understand the implementation of Good Manufacturing Practices (GMP) guidelines
at PT. Novell Pharmaceutical Laboratories. Method: The method used was
observation and direct practice by students in PKPA activities carried out from 3
January to 28 February 2025 at PT. Novell Pharmaceutical Laboratories.
Conclusion: Pharmacists at PT. Novell Pharmaceutical Laboratories have
implemented CPOB aspects well and have roles, functions, and responsibilities
based on their positions, including Business Development, Product Development,
Quality Control, Quality Assurance, Product Planning and Inventory Control
(PPIC), Training, and Analytical Development Export and Dossier. Specifically in
the Business Development division, pharmacists have roles, functions, and
responsibilities related to new product development and drug registration. | en_US |
