Document r62QyQerm5KxrzmEVKJ6JQzKq

interoffice Communication TO: FROM: DATE: SUBJ: Henrietta Lewis XF: T. G. Grumbles June 19, 1991 FDA GMP FOR ALCOHOL FLAKING FACILITIES VISTA There are no specific regulatory guidelines regarding the specifics of what is needed to comply with GMP. In general, the goal is to have practices, procedures, and, equipment that would prevent contamination of the product being processed. This would include some of the following: 1. Facility equipment that would allow segregated storage of the product. 2. Transfer lines that are free of contamination. 3. Procedures to assure handling equipment is free of contamination prior to handling the product. 4. Inspection procedures for storage equipment and product containers to detect contamination if it exists. 5. If the storage and handling equipment is to be used for other products, procedures must be in-place to assure the equipment is thoroughly cleaned and free of contamination prior to handling our product. Let me know if you want to discuss this further. T. G. Grumbles dlj VVV 000006483