Halal Certification for Pharmaceutical Products
American Halal Foundation (AHF) is North America’s leading halal certifier for pharmaceutical products. For more than 40 years, AHF’s globally recognized accreditation has enabled manufacturers to successfully enter and grow within the fast-expanding halal market. Here’s why companies choose AHF:
- Dedicated Pharma Halal Certification Specialists
- Internationally Accredited and Recognized
- Ability to Combine the Halal Audit with GMP, Gluten-Free, Non-GMO, and Vegan
Halal Certification Process for Pharmaceutical Products
Halal Certification Explainer Video
1 |
Application
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| The American Halal Foundation (AHF) will process your application. Your designated Certification Manager will guide you through the application process to determine the halal status of the facility and its products. | |
5-7 Business Days
2 |
Audit
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| Your Certification Manager will schedule a halal audit on a mutually convenient day. The audit typically lasts 4 hours and includes a training session for employees who will be responsible for overseeing the halal production. | |
3 |
Halal Certification
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🎉 Congratulations Upon the successful completion of the halal audit, your products and facility are now officially halal certified and recognized as such internationally. You may add products or facilities at any time by simply contacting your Account Executive. |
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Halal Certification Requirements for Pharmaceutical Products
Here are the general halal certification requirements for pharmaceutical products in line with the AHF halal standards:
| Area | Halal Requirement |
|---|---|
| 1. Active Pharmaceutical Ingredients (APIs) | APIs must be from halal or permissible sources. No APIs derived from pork, carnivorous animals, animals not slaughtered Islamically, or clearly haram substances (e.g., certain intoxicants, human-derived materials). |
| 2. Excipients & Additives | All excipients (gelatin, glycerin, polysorbates, stearates, lactose, flavors, colors, coatings, etc.) must be halal-compliant and traceable. |
| 3. Gelatin & Capsules | Hard/soft capsules and any gelatin used must be bovine, other halal-slaughtered animals or plant-based. Porcine gelatin is not allowed. |
| 4. Enzymes & Cultures | Enzymes, cultures, and microorganisms used in production (e.g., in fermentation) must come from halal / non-haram sources, and growth media must not contain non-halal ingredients (e.g., porcine peptones, blood, non-halal meat extracts). |
| 5. Alcohol / Ethanol Use | No intoxicant drink-derived ethanol can be used as an ingredient. For functional/technological use (e.g., solvent, disinfectant), ethanol and other solvents must comply with the halal standard’s limits and source criteria; any residual level in the final product must be within 5,000 PPM. |
| 6. Cross-Contamination Control | There must be effective segregation to prevent cross-contamination between halal and non-halal materials/products in equipment, tools, utensils, air systems, weighing/dispensing, and packaging areas. Clear physical or validated procedural controls must exist. |
| 7. Cleaning & Sanitization Chemicals | Detergents, CIP chemicals, and sanitizers used on halal contact surfaces must not contain non-halal components (e.g., porcine-derived tallow). |
| 8. Contract Manufacturers / Toll Processing | Any CMO/third-party site must fully comply with the same halal requirements (materials, segregation, cleaning, documentation) and be covered under the scope of the halal certification agreement and audits. |
| 9. Supplier Approval & Halal Documentation | All critical materials (APIs, excipients, capsules, flavors, cultures, etc.) must be supported by declarations, certificates, or other approved evidence from suppliers. Contact AHF’s technical review team to learn more. |
General Principles of Halal
The most basic heuristic to use in evaluating halal status is if the product is free from non-halal animal derivatives and ethanol. A more detailed study on the principles of halal can be read on the “What is Halal?” page.
Common Questionable Ingredients
Soft gels
Glycerine
Gelatin
Whey
Ethanol
Stearic acid
Heparin sodium
Mono-Diglycerides
Trypsin
The above ingredients are commonly used in pharmaceuticals and supplements and are of major concern to halal consumers as they may be from haram sources.
Topical Application Products
For topically applied products, there are some leniencies in terms of halal regulations on a product-by-product basis. For example, products that are for external application only may contain ethanol residuals. These cases are evaluated individually by AHF’s team of technical and religious advisors.
The Critical Need for Halal Pharmaceutical and Supplement Certification
Of all the industries the American Halal Foundation (AHF) serves, there is probably none more critical than the pharmaceutical and supplement industry. From both a practical and principles perspective, the pharmaceutical and supplement industry is critically important to AHF.
Practically, there is a large asymmetry between the supply and demand for halal pharmaceuticals. With nearly 1 in every 4 consumers globally adhering to halal, less than 5% of all pharmaceutical drugs are halal.
From a perspective of principles, AHF is “committed to building a safer, healthier, and more inclusive world.” and there is no higher moral imperative than saving a life.
To this end, AHF believes the largest untapped market in halal is currently the pharmaceutical industry.
AHF Halal Certification Scheme for Pharmaceuticals and Supplements
The halal certification scheme for pharmaceutical products is similar to the traditional halal certification process, but it does have a few salient differences. Due to the technically complex and unique applications of these products, each drug is independently evaluated based on its formulation, production method, use case, and other important factors.
Additionally, AHF looks at the product development cycle and production process and evaluates it against bio-ethics of the halal tradition. Certain pharmaceutical drugs may receive conditional certification (see “principle of necessity below”) for products that may generally not be consumable.
The halal certification process for supplements is generally in accordance with the standard halal certification process of evaluating the product compliance from a perspective of ingredients and process of production to ensure the integrity of the halal identity is not compromised at any stage of production. AHF seeks to integrate with existing quality systems such as GMP to ensure the process is as efficient as possible.
The Principle of Necessity
An important point to note is that most modern theological scholars agree that under certain dire circumstances, products that would be typically considered unlawful “haram” can be consumed.
In terms of invoking this principle as it pertains to the use of pharmaceuticals, the conditions on an individual basis are as follows:
- The necessity must be life-threatening
- There must be no halal alternative to the product
- A trained Muslim doctor must recommend the use of
the pharmaceutical - There must be a certainty that the product will be a source of cure
AHF evaluates such products on a case-by-case basis and consults with clinical, technical, and theological experts before granting conditional approval. Besides the aforementioned circumstance, halal compliance is a prerequisite for consumption for 1.9 billion halal consumers for every pharmaceutical and supplement product.
Note: Generally, this principle will not apply to health supplements.
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Obtain a Halal Certificate/License for Pharmaceutical/Supplement Products
To learn more regarding the halal certification process for pharmaceutical products or to get started, get in touch with an expert at the American Halal Foundation.
Start your application online here today or simply call the pharmaceutical division at +1 (630) 759-4981.
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