ISO Audits

From the moment the API starting material is introduced in the manufacturing process, all following manufacturing activities should be performed in accordance with GMP principles. In practice this means that intermediates, APIs and medicinal products are always manufactured according to the relevant GMPs. Other materials used in the manufacturing process for example solvents, catalysts or filters are often purchased from suppliers that apply a quality system according to ISO 9001. Even though GMP regulations are not mandatory for the suppliers, the purchased materials should be of sufficient quality, since they can be in direct contact with the manufactured API (or medicinal product) and may have a significate influence on the process. Audit frequency and scope should be determined based on the risk related to the purchased material and the supplier. Special attention should be given to sterile materials (e.g., sterile single-use systems). blue offers tailored audits of suppliers that apply an ISO 9001 quality management system under consideration of the specific needs of the pharmaceutical industry.