The impact of cost on the development of a pharmaceutical drug is primarily based on its Active pharmaceutical ingredient (API) component
Maximum of the key generic drug manufacturing firms have own API manufacturing factories, but the generic drug manufacturers who do not manufacture the API themselves are dependent on external API manufacturers for procurement of the API, for which they test the quality attributes of the API provided by the supplier
The quality attributes of the Active pharmaceutical ingredient are classified into 4 classes-
Organizational characteristics are Active pharmaceutical ingredient good manufacturing practice facility, manufacturing practices, documentation practices, deliverable capacity, quality management system, manufacture and price. The supplier should deliver all the mandatory regulatory documentation such as master drug file, logical legalization credentials and other regulatory documents.
Formulation attributes are the ones that studied in the developmental phase of the Active pharmaceutical ingredient which includes:
- Solubility: affects dissolution, disintegration, impurity profile and bioavailability
- Bulk density: content uniformity, dissolution, and uniformity of dosage
- Water Content: affects hardness, dissolution, friability, impurity profile
Synthesis related attributes is about the manufacturing or synthetic route the Active pharmaceutical ingredient takes for its production, the API synthetic route affects the physiochemical property of the API which has to evaluated and characterized as per good manufacturing guidelines. All the steps should have control over each and every attribute which include:
- Starting material: affects the route and composition of drug
- Impurities: by-products, intermediates, degradation products, reagents, heavy metals, inorganic salts and other materials
- Residual solvents: classified the in to three classes.
The analytical attribute of key importance is the specification of the Active pharmaceutical ingredient . If the API is registered in the Pharmacopoeia, then the supplier should manufacture API that obeys the present version of the pharmacopoeia specification