The manufacture of biological medicinal products involves certain specific considerations arising from the nature of the products and the processes. The ways in which biological medicinal products are manufactured, controlled and administered make some particular precautions necessary. Unlike conventional medicinal products, which are manufactured using chemical and physical techniques capable of a high degree of consistency, the manufacture of biological medicinal substances and products involves biological processes and materials, such as cultivation of cells or extraction of material from living organisms.

By recognizing what integrated supply chain means for our customers and always prioritizing it as the most important initiative. In order to audit Biological Medicinal Substances and Products manufacturing facilities we use the guidelines from several International regulatory authorities. Our GMP auditors who have Lead Auditor Certificates have an extensive knowledge and competence in Biological Medicinal Substances and Products Facilities.

Contact Regula Inspection today for a “Biological Medicinal Substances and Products Manufacturer Audit” consultation.

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