INTEGRATION OF HALAL BY DESIGN (HbD) CONCEPT INTO RAW MATERIAL MANAGEMENT AND PRODUCT DEVELOPMENT ACTIVITIES IN R&D DEPARTMENT OF KDP PHARMACEUTICAL INDUSTRY

• Main Author: Kurnia Dwinatari, Indrawan
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/39922
• Institution: Institut Teknologi Bandung

In the Republic of Indonesia Government Regulation Number 31 Year 2019 which regulates the implementation of Law Number 33 Year 2014 concerning Halal Product Assurance (JPH), it is stated that all products that enter, circulate and trade in Indonesian territory must be halal certified (Article 2). One of the products is medicines (Article 1). In addition, the increasing awareness of Muslim religious communities on the use of halal products has became the implementation of JPH a challenge and an opportunity for the pharmaceutical industry to produce quality and halal drugs. In order to produce a drug met of high quality and halal requirements, a guideline for halal production is needed which could complement the Good Manufacturing Practices (GMP). Halal by Design (HbD) is an approach concept for producing halal materials or products in accordance with Islamic Syaria. HbD has the basis that halal products can be built into the product. The research methodology used was descriptive non-experimental research by integrating the HbD concept into research activities in the R&D Dept of KDP pharmaceutical industry. This research begins by conducting a risk assessment of each product development activity on the implementation of Halal Assurance System (HAS 23000) by calculating the value of Risk Priority Number (RPN) using the Failure Mode Effect Analysis (FMEA) tool, integrating the HbD concept into raw material management and product development activities, and controlling for potential risks. After conducting the risk assessment it was found that there were four research activities that had high risk (Level C), five activities with low risk levels (Level A), and two moderate risk activities (Level B). The HbD concept was successfully integrated into raw material management activities and product development in R&D with the making of a Halal Material Assurance Form. Risk control activities in material selection activities using the HbD concept can reduce the value of RPN and level of risk for all product research and development activities in the R&D of KDP pharmaceutical industry from Level C to Level A.