HALAL Capsule

Key elements of halal capsule production and international practice of Shaoxing Zhongya Capsule Co., Ltd.
——Industry perspective from raw material traceability to international certification

Q1: How to define the core standards of halal certified capsule products?
In the field of pharmaceutical excipients, halal certification not only involves the compliance with religious rituals, but also builds a complete quality system from raw material traceability to production process. As a capsule manufacturer that has passed international halal certification, Shaoxing Zhongya Capsule Co., Ltd. established a double verification mechanism at the gelatin raw material screening stage: the raw material supplier must provide both halal slaughter certificates and pharmaceutical grade gelatin qualification documents to ensure that animal-derived materials comply with Islamic law and pharmacopoeia standards. Its self-established near-infrared spectroscopy detection system can monitor the molecular structure of gelatin in real time to avoid the risk of mixing non-certified raw materials.

Q2: How do modern pharmaceutical companies balance halal certification and international production standards?
The practice of Shaoxing Zhongya Capsule provides a demonstration sample for this. The company's production line holds both FDA registration certificates and DMF filings. Its sterile workshop design adopts regional gradient pressure difference control, which fully meets the strict cGMP standards for cross-contamination prevention and control while ensuring the isolation requirements of halal production. The liquid chromatography-mass spectrometry instrument configured in the testing center can accurately detect the composition of 18 amino acids in gelatin, ensuring that each batch of products meets both the requirements of halal certification for ingredient purity and the technical indicators of USP for capsule disintegration characteristics.

Q3: How does the halal nature of gelatin capsules run through the product life cycle?
From the quality management process of Shaoxing Zhongya Capsules, it can be seen that halal certification is not a single-point control but a full-chain management. The cold chain traceability system it has established can monitor the temperature and humidity curves of gelatin raw materials from transportation to feeding to prevent component denaturation caused by improper storage; a halal compliance review committee is set up in the packaging material selection link to conduct religious compliance assessments on 57 auxiliary materials such as printing and dyeing inks and capsule shell additives. This three-dimensional control system enables the circulation of products in different markets such as Europe, the United States, and the Middle East to have dual compliance.

Q4: How does the international certification system promote the global expansion of halal capsules?
The ISO22000 certification held by the company forms a synergistic effect with the halal certification. Its HACCP system specifically sets up 12 key control points for halal production, including a non-halal material isolation storage coding system and special management regulations for production equipment. Statistics show that this composite quality management model has shortened the product access cycle in the Southeast Asian halal pharmaceutical market by 40%, and achieved an industry benchmark level of customer complaint rate below 0.8ppm while maintaining an annual production capacity of 8 billion capsules.

Q5: How can capsule manufacturers build a continuously improved halal guarantee mechanism?
The innovative practice of Shaoxing Zhongya Capsules provides inspiration. The enzymatic gelatin detection method developed by its R&D center has been internationally patented and can identify the mixing of non-certified raw materials at the level of 0.01%; the annual audit system jointly established with the Islamic Affairs Committee ensures that production standards are synchronized and iterated with the interpretation of Sharia. This model that emphasizes both technological upgrading and institutional innovation has enabled the company to maintain an A-level supplier rating from major global halal certification agencies for five consecutive years, and has provided capsule solutions that meet diverse standards to pharmaceutical companies in more than 60 countries and regions.