CURRENT GOOD MANUFACTURING PRACTICES-HUMAN FOODS1

General regulations establishing good manufacturing practices (GMP' s) for food establishments are now effective. Under the Food, Drug, and Cosmetic Act, FDA brought many food insanitation actions. Until recently, there were no specific standards (GMP' s) dealing with the plant sanitation concept in Section 402(a) (4) of the Act. Two court opinions touching on the subject of standards (GMP' s) are mentioned. FDA's food sanitation programs now include bacteriological findings as well as the visible evidence of insanitation. The general, “umbrella” regulations will be followed by specific appendices for individual foods. If specific GMP's exist, FDA sanitary inspections will cover the key points in the GMP's. In other instances, the general regulations will apply. Such inspections will be the usual FDA sanitary inspection. FDA will continue its present procedures including: inspector's discussion with management, written reports of observations, and post-inspection letters. If necessary, FDA can still use legal sanctions available to it. Reasonableness and appropriate consideration to significant factors can be expected in FDA's administration of the GMP's. GMP's will be subject to updating and revision. Some benefits of GMP's are: (a) industry, as well as cooperating State and local agencies, have a definite statement of FDA's requirements for food plant sanitation and for compliance with Section 402(a)(4) of the FDC Act; (b) GMP's will help in the planning and implementation of cooperative food inspection programs between FDA and other agencies; and (c) GMP's will minimize actual distribution of potentially hazardous or contaminated products to consumers.