Halal pharmaceutical certification

What we assess

• The origin of every active ingredient and excipient
• Gelatine and capsule shells, stearates and glycerol, which are the most common doubtful ingredients
• Alcohol-based solvents and co-solvents in liquids and tinctures
• Separation of halal product from non-conforming product during preparation, handling, packaging, storage and distribution
• A documented halal management system and internal checks

Halal assessment is separate from regulatory approval. Your product must meet the health authority's registration and manufacturing rules as well.

Where authorities differ

• Gelatine. Gelatine from properly slaughtered permitted animals, and from fish, is generally accepted. Pig gelatine is prohibited by most scholars, but a minority view accepts it after transformation. Plant-based capsule shells avoid the question.
• Alcohol in medicines. Some bodies allow small, essential quantities when prescribed by a competent doctor and treat large quantities as a matter of necessity only. Malaysian committee decisions allow alcohol as a solvent in medicines when it is not from liquor production. Some scholars advise avoiding alcohol where alternatives exist.
• Medicines in necessity. Several fatwa bodies accept a patient using a medicine that contains a prohibited ingredient only where there is necessity, no halal alternative, and competent medical advice.

Whether halal certification is mandatory depends on the market, so check the rule for your destination.

Common issues

Missing information on where an ingredient comes from; imported raw materials with long supply chains; pig-derived enzymes in processing; gelatine stabilisers; animal-source excipients that are not declared.

Documents we usually ask for

Your halal policy and quality manual, certificates of analysis for materials and finished product, procedures, batch records, training records, product flow, and halal certificates or safety data sheets for materials of doubtful origin.

Frequently asked questions