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.
Where the problem lies
The active ingredient is rarely the obstacle. The excipients are, and they make up most of the product's mass:
- Gelatine capsules. The most cited case. Plant alternatives exist but change dissolution parameters, which can mean redoing studies.
- Stearates and compression lubricants. Very common, and frequently of animal fat origin.
- Lactose. Its suitability depends on the production process, particularly the enzymes used.
- Alcohol in syrups and solutions. As solvent or preservative, present in many paediatric formulations.
- Coatings and colourants. Where derivatives such as shellac or carmine appear.
The question of therapeutic necessity
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: it is not a wildcard. It applies case by case, requires demonstrating that no alternative is available, and does not exempt you from documenting composition.
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.
What is audited
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.
Where to start
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.