ISO-A

ISO-A: Comprehensive Identification for Medicinal Products

The ISO-A standard is designed to ensure the accurate identification of medicinal products throughout their entire life cycle. This includes defining and characterizing substances within these products, as well as identifying ingredients in dietary supplements, food, veterinary medical products, and cosmetics. The standard requires detailed information about each substance, including its main general characteristics and the role it plays in the product (active, adjuvant, etc.). Additionally, specific substances must include descriptions related to manufacturing information, grade of purity, and more.

ISO-A also plays a crucial role in pharmacovigilance and regulatory activities worldwide by providing a structured format for Pharmaceutical Product Identification (PhPID). This format typically includes the substance name, dosage form, strength, and unit of measurement (e.g., Acetaminophen tablet, 500 mg). This structured format is essential for e-prescribing and clinical decision support, ensuring that medical professionals have the necessary information to make accurate diagnoses and administer proper treatments.

By following the ISO-A standard, companies can foster trust with consumers, regulatory authorities, and the global marketplace. This standard is particularly important in the healthcare industry, where even small errors in measurement, translation, or labeling could result in misdiagnosis, improper treatment, or significant injury. The ISO-A standard helps combat these issues by promoting a better exchange of medical product information between stakeholders, thereby enhancing patient safety and regulatory compliance.