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My company is a contract manufacturer for Solid Oral Dose products. We have a potential contract for a biologic (enzyme) product that will be consumed orally. Are there restrictions on dedicated space (e.g, dedicate air handling, equipment, processing rooms). We plan to dedicate equipment were possible and have cleaning validation and carry over studies. This is my first time dealing with a biologic product. Can someone direct me to the appropriate guidance(s) that I should review?
Thank you