Document wDVzrY6aqqKd7gBQ3Dqq5yGXo

4 To: F rom: Paul Gowan J . C. Ledvina Date: December 29, 1989 Subject: PVC Food And Drug Administration Status Paul , Transportation of PVC and any Ex--plant activities with Vista PVC must be done in a manner to assure that Vista's status as an FDA allowed supplier is not jeopardized. An S&T procedure should be developed to minimize adulteration of FDA allowed PVC between the plant and the customer. The Aberdeen plant is currently writing a Good Manufacturing Practices manual to assure that PVC is made with appropriate ingredients and to eliminate the possibility of cross--contamination at the plant. The manual will cover resin for all stages of manufacturing up to the point it is put into silos and for on-site bagging and boxing. Bulk shipments in hopper cars or trucks will not be in the plant GMP manual. Neither will there be procedures covering toll operations or warehousing. There has never been a formal FDA procedure for S&T operations. In order to insure that Vista PVC reaches the customer in an FDA allowed state, the gap in procedures needs to be closed. It seems appropriate that a meeting of S&T, Legal, Plant, and Environmental take place to get this kicked off. What are your thoughts? cc: W. McClain, K. Birck, R. Seymour, D. Skokna, R. Smith, D. Fenton VEV-144741 -f T o Paul Gowan From s J . C. Ledvina Date: December 29, 1989 Subject: PVC Food And Drug Administration Status Paul Transportation of PVC and any Ex-plant activities with Vista PVC must be done in a manner to assure that Vista's status as an FDA allowed supplier is not jeopardized. An S&T procedure should be developed to minimize adulteration of FDA allowed PVC between the plant and the customer. The Aberdeen plant is currently writing a Good Manufacturing Practices manual to assure that PVC is made with appropriate ingredients and to eliminate the possibility of cross--contamination at the plant. The manual will cover resin for all stages of manufacturing up to the point it is put into silos and for on-site bagging and boxing. Bulk shipments in hopper cars or trucks will not be in the plant GMP manual. Neither will there be procedures covering toll operations or warehousing. There has never been a formal FDA procedure for S&T operations. In order to insure that Vista PVC reaches the customer in an FDA allowed state, the gap in procedures needs to be closed. It seems appropriate that a meeting of S&T, Legal, Plant, and Environmental take place to get this kicked off. What are your thoughts? J. C. Ledvina y cc: W. -McClain, K. Birck, R. Seymour, D. Skokna, R. Smith, D. Fen ton 44742