INTEGRATION OF HALAL BY DESIGN (HbD) CONCEPT INTO RAW MATERIAL MANAGEMENT AND PRODUCT DEVELOPMENT ACTIVITIES IN R&D DEPARTMENT OF KDP PHARMACEUTICAL INDUSTRY
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)...
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Format: | Theses |
Language: | Indonesia |
Online Access: | https://digilib.itb.ac.id/gdl/view/39922 |
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Institution: | Institut Teknologi Bandung |
Language: | Indonesia |
Summary: | 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.
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