Operating Characteristic
Distributor(s) with which the manufacturer has a business relationship; usually a formal distribution agreement.
Out of Trend
Operational Qualification
Person or company manufacturing a material to the stage at which it is designated as a pharmaceutical starting material. (GDP Guide/WHO Good Trade and Distribution Practices)[1] [2][16]
Materials present in an excipient that arise as a consequence of the raw materials and/or manufacturing process and are not concomitant component.
Organic Volatile Impurities, USP/NF General Chapter <467> [6]