Strategy to Implement Halal Certification for Pharmaceutical Manufacturing in Indonesia

Abstract

The high dependence of the national pharmaceutical industry on imported raw materials, which account for 90 per cent, and the complexity of using animal-derived ingredients, such as gelatin, enzymes, and hormones, pose significant challenges in fulfilling halal certification obligations under Law Number 33 of 2014. Various technical and operational obstacles often hinder the implementation of these regulations, preventing the alignment of Good Manufacturing Practices (GMP) standards with the Halal Product Assurance System (HPAS). This research aims to develop a comprehensive, adaptive, and contextual halal certification implementation strategy for the pharmaceutical industry in Indonesia. This research aims to bridge the gap between religious legal obligations and operational realities on the production floor, to enhance the competitiveness of the national pharmaceutical industry in the global market. The researcher employs a descriptive qualitative design, integrating normative literature reviews and juridical approaches to explore implementation strategies. Secondary data were collected through a systematic literature search and documentation of academic manuscripts, regulations, and CPOB technical documents. Data analysis is conducted using content analysis and deductive logic to produce a comprehensive, sustainable synthesis of strategies. The results of the study demonstrate that integrating halal regulations leads to a transformation of the quality system, in which the halal aspect becomes an intrinsic quality parameter integrated with the CPOB standard. The researcher synthesised the Pentahelix Collaboration Model as an original solution to accelerate the achievement of raw material independence through the synergy of industry, regulators, academics, scholars, and the community. The use of information technology for digital tracking (traceability) has been proven to reduce verification time for halal status of raw materials by up to 30 per cent, compared with manual systems. The organisational restructuring through the Halal Management Team has successfully changed the industry paradigm from burden-based compliance to a long-term strategic investment that strengthens national health resilience