DESIGN OF DOCUMENTATION MODELS IN HALAL SUPPLY CHAINS IN THE PHARMACEUTICAL INDUSTRY OF PT. X

• Main Author: Solehuddin, Yanyan
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/50473
• Institution: Institut Teknologi Bandung

Indonesia is a country with the largest Muslim population in the world. Current conditions, the growth of halal products both halal food, halal cosmetics, and halal pharmaceuticals are very high so that it has the potential to become the center of the global halal industry. One way to support it is to carry out the halal certification process following applicable regulations. Halal products have become an essential need for Muslims. Law No. 33 of 2014 concerning Halal Products Assurance in Indonesia shows that the Indonesian government also guarantees and protects Muslim populations to consume halal products. Law Number 33 of 2014 Regarding Halal Product Assurance (JPH) stipulates that products that imported circulating and traded in the territory of Indonesia must be halal certified (Article 4), and one of the intended products is medicine (Article 1) so that halal certification of drugs. Applying Good Manufacturing Practices (CPOB) and Halal Assurance System (SJH) supported by Qualified Supply Chain Management is a challenge and an opportunity for the Pharmaceutical Industry to produce products that meet quality requirements of halal products. SCM or Supply Chain Systems are used to efficiently integrate suppliers, producers, warehouses, and retailers so that goods produced and distributed in the right amount, to the correct location, and at the right time to minimize costs and meeting service level requirements. Halal Supply Chain Management regulates the supply of raw materials for production, processing, marketing, promotion until the products are ready for consumption must comply with halal standards. Pharmaceutical Industry PT. X is a company engaged in the production of medicines. PT X has implemented Good Manufacturing Practices (GMP) and used halal standards set by MUI's LPPOM and manually compiled Halal Assurance System (SJH) and documented. This research focuses on the supply chain halal system for procurement, storage, and processing. The research methodology used is descriptive non-experimental research by integrating the Halal Assurance System (SJH) in the supply, storage, and processing activities in the Pharmaceutical Industry PT. X. The study began by analyzing the gap between SJH and the main point of the procurement, storage, and processing processes. This study carried out on the implementation of the Halal Assurance System (SJH) by calculating the value of the Risk Priority Number (RPN) with Failure Mode Effect Analysis (FMEA) tool, then mitigating to reduce the risks that occur to be able to control potential hazards. After a risk assessment has carried out on the main activities of the procurement, storage, and processing processes, there are 11 (eleven) risk levels resulting from a risk analysis study with 3 (three) critical levels and 8 (eight) major levels. A document model design carried out on the important activities of the procurement, storage, and processing processes to reduce the risk. A review of the remaining uncertainties, improvements to the document, can reduce the value of the RPN and the level of risk for all procurement, storage, and processing activities to the minor scale. The halal documentation model design at PT X tested during the halal certification audit at the end of 2020. The improvement of the halal document expected to ensure halal integrity throughout the supply chain process. It assumed that the design of halal documentation used as a reference throughout the pharmaceutical industry, which will carry out halal certification.