[{"data":1,"prerenderedAt":23},["ShallowReactive",2],{"cms:page\u002Fglobal:en":3,"post:halal-certification-in-pharmaceuticals:en":8},[4],{"section":5,"content":6},"links",{"app_url":7},"https:\u002F\u002Fapp.hqceurope.com",{"key":9,"slug":10,"title":11,"excerpt":12,"cover":13,"published_at":14,"body":15,"seo_title":16,"seo_description":17,"sources":18,"translations":21},"halal-farmaceutico","halal-certification-in-pharmaceuticals","Halal certification in pharmaceuticals: the most complex case","Halal pharma combines religious requirements with a strict regulatory framework. It is the sector where an apparently innocuous excipient decides the file.",null,"2026-08-20","\u003Cp>Of all the sectors we certify, pharmaceuticals has the most nuance. Not only because of the nature of the ingredients, but because it coexists with a regulatory framework that cannot be altered for certification reasons: a formulation approved by the health authority is not easily changed.\u003C\u002Fp>\n\u003Ch2>Where the problem lies\u003C\u002Fh2>\n\u003Cp>The active ingredient is rarely the obstacle. The excipients are, and they make up most of the product's mass:\u003C\u002Fp>\n\u003Cul>\n  \u003Cli>\u003Cstrong>Gelatine capsules.\u003C\u002Fstrong> The most cited case. Plant alternatives exist but change dissolution parameters, which can mean redoing studies.\u003C\u002Fli>\n  \u003Cli>\u003Cstrong>Stearates and compression lubricants.\u003C\u002Fstrong> Very common, and frequently of animal fat origin.\u003C\u002Fli>\n  \u003Cli>\u003Cstrong>Lactose.\u003C\u002Fstrong> Its suitability depends on the production process, particularly the enzymes used.\u003C\u002Fli>\n  \u003Cli>\u003Cstrong>Alcohol in syrups and solutions.\u003C\u002Fstrong> As solvent or preservative, present in many paediatric formulations.\u003C\u002Fli>\n  \u003Cli>\u003Cstrong>Coatings and colourants.\u003C\u002Fstrong> Where derivatives such as shellac or carmine appear.\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Ch2>The question of therapeutic necessity\u003C\u002Fh2>\n\u003Cp>There is a widely recognised principle whereby, faced with a medical need and in the absence of an alternative, what would not otherwise be admitted becomes admissible. It is a real principle, but it should be understood properly: \u003Cstrong>it is not a wildcard\u003C\u002Fstrong>. It applies case by case, requires demonstrating that no alternative is available, and does not exempt you from documenting composition.\u003C\u002Fp>\n\u003Cp>Relying on it as a certification strategy is a frequent mistake. The sensible approach is to treat it as a last resort, not a starting point.\u003C\u002Fp>\n\u003Ch2>What is audited\u003C\u002Fh2>\n\u003Cp>Beyond the composition file, the audit reviews line separation — especially where formulations with unsuitable material are produced — validated cleaning procedures, batch traceability and the documentation system. In pharma this is usually already solved by good manufacturing practice, which makes the work considerably easier.\u003C\u002Fp>\n\u003Ch2>Where to start\u003C\u002Fh2>\n\u003Cp>Review the excipient list for your highest-turnover products and sort them into three groups: documented suitable, doubtful, and unsuitable. That map decides whether the route is certifying the current range or reformulating a specific line for export.\u003C\u002Fp>","Halal certification in pharmaceuticals","Halal requirements in pharma: excipients, gelatine capsules, alcohol in syrups and the therapeutic necessity exception.",[19,20],"SMIIC standards applicable to halal pharmaceuticals","Good Manufacturing Practice (GMP) applying in parallel",{"es":22,"en":10},"certificacion-halal-en-productos-farmaceuticos",1788376549703]