{"id":375284,"date":"2025-01-09T09:26:24","date_gmt":"2025-01-09T14:26:24","guid":{"rendered":"https:\/\/caiready.com\/life-sciences\/blog\/%cf%83%cf%85%ce%bc%ce%bc%cf%8c%cf%81%cf%86%cf%89%cf%83%ce%b7-pic-s-%ce%ba%ce%b1%ce%b9-eu-gmp\/"},"modified":"2025-01-09T09:26:24","modified_gmt":"2025-01-09T14:26:24","slug":"%cf%83%cf%85%ce%bc%ce%bc%cf%8c%cf%81%cf%86%cf%89%cf%83%ce%b7-pic-s-%ce%ba%ce%b1%ce%b9-eu-gmp","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/el\/blog\/%cf%83%cf%85%ce%bc%ce%bc%cf%8c%cf%81%cf%86%cf%89%cf%83%ce%b7-pic-s-%ce%ba%ce%b1%ce%b9-eu-gmp\/","title":{"rendered":"\u03a3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7: PIC\/S \u03ba\u03b1\u03b9 EU GMP"},"content":{"rendered":"\n

\u0395\u03b9\u03c3\u03b1\u03b3\u03c9\u03b3\u03ae<\/h3>\n\n\n\n

\u0397 PIC\/S \u03b9\u03b4\u03c1\u03cd\u03b8\u03b7\u03ba\u03b5 \u03c4\u03bf 1995 \u03c9\u03c2 \u03b5\u03c0\u03ad\u03ba\u03c4\u03b1\u03c3\u03b7 \u03c4\u03b7\u03c2 PIC (\u03a3\u03cd\u03bc\u03b2\u03b1\u03c3\u03b7 \u03a6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03ae\u03c2 \u0395\u03c0\u03b9\u03b8\u03b5\u03ce\u03c1\u03b7\u03c3\u03b7\u03c2). \u03a0\u03c1\u03cc\u03ba\u03b5\u03b9\u03c4\u03b1\u03b9 \u03b3\u03b9\u03b1 \u03bc\u03b9\u03b1 \u03bc\u03b7 \u03b4\u03b5\u03c3\u03bc\u03b5\u03c5\u03c4\u03b9\u03ba\u03ae \u03c3\u03c5\u03bc\u03c6\u03c9\u03bd\u03af\u03b1 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1\u03c2 \u03bc\u03b5\u03c4\u03b1\u03be\u03cd 56 \u03b4\u03b9\u03b1\u03c6\u03bf\u03c1\u03b5\u03c4\u03b9\u03ba\u03ce\u03bd \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03c4\u03b9\u03ba\u03ce\u03bd \u03b1\u03c1\u03c7\u03ce\u03bd. \u0397 \u03b1\u03c0\u03bb\u03ae \u03b8\u03ad\u03b1\u03c3\u03b7 \u03c4\u03bf\u03c5 \u03b1\u03c1\u03b9\u03b8\u03bc\u03bf\u03cd 56 \u03b4\u03b5\u03bd \u03ad\u03c7\u03b5\u03b9 \u03c4\u03bf\u03bd \u03af\u03b4\u03b9\u03bf \u03b1\u03bd\u03c4\u03af\u03ba\u03c4\u03c5\u03c0\u03bf \u03bc\u03b5 \u03c4\u03b7\u03bd \u03b8\u03ad\u03b1\u03c3\u03b7 \u03c4\u03bf\u03c5 \u03c0\u03b1\u03c1\u03b1\u03ba\u03ac\u03c4\u03c9 \u03c7\u03ac\u03c1\u03c4\u03b7 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03ba\u03b1\u03c4\u03b1\u03bd\u03cc\u03b7\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03c0\u03c1\u03b1\u03b3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ae\u03c2 \u03c0\u03b1\u03b3\u03ba\u03cc\u03c3\u03bc\u03b9\u03b1\u03c2 \u03b5\u03bc\u03b2\u03ad\u03bb\u03b5\u03b9\u03b1\u03c2 \u03c4\u03b7\u03c2 PIC\/S. \u0397 \u03b1\u03c0\u03bf\u03c3\u03c4\u03bf\u03bb\u03ae \u03c4\u03bf\u03c5\u03c2 \u03b5\u03af\u03bd\u03b1\u03b9 “\u03bd\u03b1 \u03b7\u03b3\u03b5\u03af\u03c4\u03b1\u03b9 \u03c4\u03b7\u03c2 \u03b4\u03b9\u03b5\u03b8\u03bd\u03bf\u03cd\u03c2 \u03b1\u03bd\u03ac\u03c0\u03c4\u03c5\u03be\u03b7\u03c2, \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae\u03c2 \u03ba\u03b1\u03b9 \u03b4\u03b9\u03b1\u03c4\u03ae\u03c1\u03b7\u03c3\u03b7\u03c2 \u03b5\u03bd\u03b1\u03c1\u03bc\u03bf\u03bd\u03b9\u03c3\u03bc\u03ad\u03bd\u03c9\u03bd \u03c0\u03c1\u03bf\u03c4\u03cd\u03c0\u03c9\u03bd GMP \u03ba\u03b1\u03b9 \u03c3\u03c5\u03c3\u03c4\u03b7\u03bc\u03ac\u03c4\u03c9\u03bd \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03c4\u03c9\u03bd \u03b5\u03c0\u03b9\u03b8\u03b5\u03c9\u03c1\u03ae\u03c3\u03b5\u03c9\u03bd \u03c3\u03c4\u03bf\u03bd \u03c4\u03bf\u03bc\u03ad\u03b1 \u03c4\u03c9\u03bd \u03c6\u03b1\u03c1\u03bc\u03ac\u03ba\u03c9\u03bd”. <\/strong><\/em>\u0397 PIC\/S \u03b4\u03b5\u03bd \u03b5\u03af\u03bd\u03b1\u03b9 \u03b1\u03bd\u03bf\u03b9\u03ba\u03c4\u03ae \u03c3\u03b5 \u03bf\u03c0\u03bf\u03b9\u03bf\u03bd\u03b4\u03ae\u03c0\u03bf\u03c4\u03b5, \u03b7 <\/em>\u03b9\u03b4\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1 \u03c4\u03bf\u03c5 \u03bc\u03ad\u03bb\u03bf\u03c5\u03c2 \u03c0\u03b5\u03c1\u03b9\u03bf\u03c1\u03af\u03b6\u03b5\u03c4\u03b1\u03b9 \u03bc\u03cc\u03bd\u03bf \u03c3\u03c4\u03b9\u03c2 \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c1\u03c7\u03ad\u03c2. \u0391\u03c5\u03c4\u03cc \u03c3\u03b7\u03bc\u03b1\u03af\u03bd\u03b5\u03b9 \u03cc\u03c4\u03b9 \u03bf\u03b9 \u03b9\u03b4\u03b9\u03ce\u03c4\u03b5\u03c2 \u03ba\u03b1\u03b9 \u03bf\u03b9 \u03b5\u03c4\u03b1\u03b9\u03c1\u03b5\u03af\u03b5\u03c2 \u03b4\u03b5\u03bd \u03bc\u03c0\u03bf\u03c1\u03bf\u03cd\u03bd \u03bd\u03b1 \u03b5\u03bd\u03c4\u03b1\u03c7\u03b8\u03bf\u03cd\u03bd \u03ae \u03bd\u03b1 \u03b5\u03c0\u03b7\u03c1\u03b5\u03ac\u03c3\u03bf\u03c5\u03bd \u03c4\u03b7 \u03c3\u03c5\u03b3\u03b3\u03c1\u03b1\u03c6\u03ae \u03c4\u03c9\u03bd \u03ba\u03b1\u03c4\u03b5\u03c5\u03b8\u03c5\u03bd\u03c4\u03ae\u03c1\u03b9\u03c9\u03bd \u03bf\u03b4\u03b7\u03b3\u03b9\u03ce\u03bd \u03cc\u03c4\u03b1\u03bd \u03b1\u03c5\u03c4\u03ad\u03c2 \u03c3\u03c5\u03bd\u03c4\u03b1\u03c7\u03b8\u03bf\u03cd\u03bd. <\/p>\n

<\/p>\n\n\n\n

\"\"<\/a><\/figure><\/div>\n\n\n\n

\u039c\u03b5\u03c4\u03ac \u03c4\u03b9\u03c2 \u03b5\u03c0\u03b9\u03ba\u03b1\u03b9\u03c1\u03bf\u03c0\u03bf\u03b9\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03bf\u03c5 \u03a0\u03b1\u03c1\u03b1\u03c1\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 1, \u03b7 PIC\/S \u03b4\u03b7\u03bc\u03bf\u03c3\u03af\u03b5\u03c5\u03c3\u03b5 \u03ad\u03bd\u03b1 \u03bd\u03ad\u03bf \u03ad\u03b3\u03b3\u03c1\u03b1\u03c6\u03bf<\/i> \u03ba\u03b1\u03b8\u03bf\u03b4\u03ae\u03b3\u03b7\u03c3\u03b7\u03c2 \u03bc\u03b5 \u03c4\u03af\u03c4\u03bb\u03bf “Guide to Good Manufacturing Practice for Medicinal Products, Annexes” \u03c3\u03c4\u03b9\u03c2 25 \u0391\u03c5\u03b3\u03bf\u03cd\u03c3\u03c4\u03bf\u03c5 2023, \u03c4\u03b7\u03bd \u03af\u03b4\u03b9\u03b1 \u03b7\u03bc\u03b5\u03c1\u03bf\u03bc\u03b7\u03bd\u03af\u03b1 \u03c0\u03bf\u03c5 \u03c4\u03ad\u03b8\u03b7\u03ba\u03b5 \u03c3\u03b5 \u03b9\u03c3\u03c7\u03cd \u03c4\u03bf \u03a0\u03b1\u03c1\u03ac\u03c1\u03c4\u03b7\u03bc\u03b1 1<\/i>. \u0391\u03c5\u03c4\u03cc \u03c6\u03b1\u03af\u03bd\u03b5\u03c4\u03b1\u03b9 \u03bd\u03b1 \u03b5\u03c5\u03b8\u03c5\u03b3\u03c1\u03b1\u03bc\u03bc\u03af\u03b6\u03b5\u03c4\u03b1\u03b9 \u03ba\u03b1\u03c4\u03ac \u03c3\u03cd\u03bc\u03c0\u03c4\u03c9\u03c3\u03b7. <\/p>\n\n\n\n

\u039f\u03b4\u03b7\u03b3\u03cc\u03c2 PIC\/S \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03bf\u03c1\u03b8\u03ae \u03c0\u03b1\u03c1\u03b1\u03c3\u03ba\u03b5\u03c5\u03b1\u03c3\u03c4\u03b9\u03ba\u03ae \u03c0\u03c1\u03b1\u03ba\u03c4\u03b9\u03ba\u03ae \u03b3\u03b9\u03b1 \u03c4\u03b1 \u03c6\u03ac\u03c1\u03bc\u03b1\u03ba\u03b1 \u03a0\u03b1\u03c1\u03b1\u03c1\u03c4\u03ae\u03bc\u03b1\u03c4\u03b1<\/h3>\n\n\n\n

\u039f \u03bf\u03b4\u03b7\u03b3\u03cc\u03c2 PIC\/S GMP \u03b4\u03b7\u03bc\u03bf\u03c3\u03b9\u03b5\u03cd\u03b8\u03b7\u03ba\u03b5 \u03c4\u03bf\u03bd \u0394\u03b5\u03ba\u03ad\u03bc\u03b2\u03c1\u03b9\u03bf \u03c4\u03bf\u03c5 2000 \u03ba\u03b1\u03b9 \u03ad\u03c7\u03b5\u03b9 \u03c5\u03c0\u03bf\u03c3\u03c4\u03b5\u03af 19 \u03b1\u03bd\u03b1\u03b8\u03b5\u03c9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2. \u03a7\u03c9\u03c1\u03af\u03b6\u03b5\u03c4\u03b1\u03b9 \u03c3\u03b5 \u03c4\u03ad\u03c3\u03c3\u03b5\u03c1\u03b9\u03c2 \u03c3\u03c5\u03bd\u03b4\u03b5\u03b4\u03b5\u03bc\u03ad\u03bd\u03b5\u03c2 \u03ba\u03cd\u03c1\u03b9\u03b5\u03c2 \u03b4\u03b7\u03bc\u03bf\u03c3\u03b9\u03b5\u03cd\u03c3\u03b5\u03b9\u03c2, \u03b4\u03cd\u03bf \u03ba\u03cd\u03c1\u03b9\u03b5\u03c2 \u03b5\u03bd\u03cc\u03c4\u03b7\u03c4\u03b5\u03c2 \u03ba\u03b1\u03b9 \u03b4\u03b9\u03ac\u03c6\u03bf\u03c1\u03b1 \u03c0\u03b1\u03c1\u03b1\u03c1\u03c4\u03ae\u03bc\u03b1\u03c4\u03b1. \u03a4\u03bf \u03bc\u03ad\u03c1\u03bf\u03c2 1 \u03b5\u03c0\u03b9\u03ba\u03b5\u03bd\u03c4\u03c1\u03ce\u03bd\u03b5\u03c4\u03b1\u03b9 \u03c3\u03c4\u03b9\u03c2 \u03b1\u03c1\u03c7\u03ad\u03c2 \u03c4\u03b7\u03c2 GMP \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03c0\u03b1\u03c1\u03b1\u03c3\u03ba\u03b5\u03c5\u03ae \u03c6\u03b1\u03c1\u03bc\u03ac\u03ba\u03c9\u03bd \u03ba\u03b1\u03b9 \u03c0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 \u03c4\u03b1 \u03b5\u03bd\u03bd\u03ad\u03b1 \u03ba\u03b5\u03c6\u03ac\u03bb\u03b1\u03b9\u03b1 \u03c4\u03b7\u03c2 \u0395\u0395 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd GMP. \u03a4\u03bf \u03bc\u03ad\u03c1\u03bf\u03c2 2 \u03b5\u03c0\u03b9\u03ba\u03b5\u03bd\u03c4\u03c1\u03ce\u03bd\u03b5\u03c4\u03b1\u03b9 \u03c3\u03c4\u03b1 API \u03ba\u03b1\u03b9 \u03c0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 20 \u03b4\u03b9\u03b1\u03c6\u03bf\u03c1\u03b5\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b5\u03bd\u03cc\u03c4\u03b7\u03c4\u03b5\u03c2. <\/p>\n\n\n\n

\u0397 \u03c4\u03b5\u03bb\u03b5\u03c5\u03c4\u03b1\u03af\u03b1 \u03b1\u03bd\u03b1\u03b8\u03b5\u03ce\u03c1\u03b7\u03c3\u03b7 \u03c4\u03bf\u03c5 \u03bf\u03b4\u03b7\u03b3\u03bf\u03cd PIC\/S GMP \u03c4\u03bf\u03bd \u0391\u03cd\u03b3\u03bf\u03c5\u03c3\u03c4\u03bf \u03c4\u03bf\u03c5 2023 \u03c4\u03bf\u03bd \u03b5\u03c5\u03b8\u03c5\u03b3\u03c1\u03b1\u03bc\u03bc\u03af\u03b6\u03b5\u03b9 \u03bc\u03b5 \u03c4\u03bf \u03b1\u03bd\u03b1\u03b8\u03b5\u03c9\u03c1\u03b7\u03bc\u03ad\u03bd\u03bf \u03c0\u03b1\u03c1\u03ac\u03c1\u03c4\u03b7\u03bc\u03b1 1. <\/p>\n\n\n\n

\u0391\u03bd \u03ba\u03b1\u03b9 \u03b4\u03b5\u03bd \u03c5\u03c0\u03ac\u03c1\u03c7\u03bf\u03c5\u03bd \u03c0\u03bf\u03bb\u03bb\u03ad\u03c2 \u03b4\u03b9\u03b1\u03c6\u03bf\u03c1\u03ad\u03c2 \u03bc\u03b5\u03c4\u03b1\u03be\u03cd \u03c4\u03bf\u03c5 \u03bf\u03b4\u03b7\u03b3\u03bf\u03cd GMP PIC\/S \u03ba\u03b1\u03b9 \u03c4\u03c9\u03bd \u03bf\u03b4\u03b7\u03b3\u03ce\u03bd GMP \u03c4\u03b7\u03c2 \u0395\u0395, \u03bc\u03b5\u03c1\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c0\u03cc \u03b1\u03c5\u03c4\u03ad\u03c2 \u03b5\u03c0\u03b9\u03c3\u03b7\u03bc\u03b1\u03af\u03bd\u03bf\u03bd\u03c4\u03b1\u03b9 \u03c0\u03b1\u03c1\u03b1\u03ba\u03ac\u03c4\u03c9:<\/p>\n\n\n\n

    \n
  • \u03a4\u03bf \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03cc \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd \u03b1\u03bd\u03b1\u03c6\u03ad\u03c1\u03b5\u03c4\u03b1\u03b9 \u03c9\u03c2 \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03cc \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd \u03c3\u03c4\u03bf\u03bd \u03bf\u03b4\u03b7\u03b3\u03cc PIC\/S GMP.<\/li>\n\n\n\n
  • \u039f \u03bf\u03b4\u03b7\u03b3\u03cc\u03c2 PIC\/S GMP Guide \u03b4\u03b5\u03bd \u03b1\u03bd\u03b1\u03c6\u03ad\u03c1\u03b5\u03c4\u03b1\u03b9 \u03c3\u03b5 \u03bf\u03b4\u03b7\u03b3\u03af\u03b5\u03c2 \u03c4\u03b7\u03c2 \u0395\u0395 \u03ae MRAs.<\/li>\n\n\n\n
  • \u03a4\u03bf \u03b5\u03b9\u03b4\u03b9\u03ba\u03b5\u03c5\u03bc\u03ad\u03bd\u03bf \u03c0\u03c1\u03cc\u03c3\u03c9\u03c0\u03bf \u03b1\u03bd\u03b1\u03c6\u03ad\u03c1\u03b5\u03c4\u03b1\u03b9 \u03c9\u03c2 \u03b5\u03be\u03bf\u03c5\u03c3\u03b9\u03bf\u03b4\u03bf\u03c4\u03b7\u03bc\u03ad\u03bd\u03bf \u03c0\u03c1\u03cc\u03c3\u03c9\u03c0\u03bf \u03c3\u03c4\u03bf\u03bd \u03bf\u03b4\u03b7\u03b3\u03cc PIC\/S GMP.<\/li>\n\n\n\n
  • \u0394\u03b5\u03b4\u03bf\u03bc\u03ad\u03bd\u03bf\u03c5 \u03cc\u03c4\u03b9 \u03b4\u03b5\u03bd \u03b5\u03af\u03bd\u03b1\u03b9 \u03cc\u03bb\u03b5\u03c2 \u03bf\u03b9 \u03c3\u03c5\u03bc\u03bc\u03b5\u03c4\u03ad\u03c7\u03bf\u03c5\u03c3\u03b5\u03c2 \u03b1\u03c1\u03c7\u03ad\u03c2 \u03c3\u03c4\u03bf \u03c0\u03bb\u03b1\u03af\u03c3\u03b9\u03bf \u03c4\u03bf\u03c5 \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 PIC \u03c3\u03c5\u03bc\u03b2\u03b1\u03bb\u03bb\u03cc\u03bc\u03b5\u03bd\u03b1 \u03bc\u03ad\u03c1\u03b7 \u03c4\u03b7\u03c2 \u03a3\u03cd\u03bc\u03b2\u03b1\u03c3\u03b7\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u0395\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03ae \u03a6\u03b1\u03c1\u03bc\u03b1\u03ba\u03bf\u03c0\u03bf\u03b9\u03af\u03b1, \u03bf \u03bf\u03b4\u03b7\u03b3\u03cc\u03c2 PIC\/S \u03b1\u03bd\u03b1\u03c6\u03ad\u03c1\u03b5\u03b9 \u03b1\u03c0\u03bb\u03ce\u03c2 \u03c4\u03b7\u03bd \u0395\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03ae \u03ae \u03ac\u03bb\u03bb\u03b7 \u03c3\u03c7\u03b5\u03c4\u03b9\u03ba\u03ae \u03a6\u03b1\u03c1\u03bc\u03b1\u03ba\u03bf\u03c0\u03bf\u03b9\u03af\u03b1.<\/li>\n<\/ul>\n\n\n\n

    \u03a0\u03b1\u03c1\u03ac\u03c1\u03c4\u03b7\u03bc\u03b1 1 \u0391\u03bd\u03b1\u03ba\u03b5\u03c6\u03b1\u03bb\u03b1\u03af\u03c9\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03b1\u03bd\u03b1\u03b8\u03b5\u03ce\u03c1\u03b7\u03c3\u03b7\u03c2<\/h3>\n\n\n\n

    \u03a0\u03b1\u03c1\u03cc\u03bb\u03bf \u03c0\u03bf\u03c5 \u03c4\u03bf \u03c0\u03b1\u03c1\u03ac\u03c1\u03c4\u03b7\u03bc\u03b1 1 \u03b4\u03b5\u03bd \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03c4\u03bf \u03b5\u03c0\u03af\u03ba\u03b5\u03bd\u03c4\u03c1\u03bf \u03b1\u03c5\u03c4\u03bf\u03cd \u03c4\u03bf\u03c5 \u03b9\u03c3\u03c4\u03bf\u03bb\u03bf\u03b3\u03af\u03bf\u03c5, \u03c0\u03b1\u03c1\u03b1\u03b8\u03ad\u03c4\u03bf\u03c5\u03bc\u03b5 \u03bc\u03b9\u03b1 \u03c3\u03cd\u03bd\u03c4\u03bf\u03bc\u03b7 \u03c5\u03c0\u03b5\u03bd\u03b8\u03cd\u03bc\u03b9\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03bc\u03b5\u03b3\u03ac\u03bb\u03b7\u03c2 \u03b1\u03bd\u03b1\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7\u03c2 \u03c4\u03bf\u03c5 \u03c0\u03b1\u03c1\u03b1\u03c1\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 1 \u03b3\u03b9\u03b1 \u03bd\u03b1 \u03c3\u03c7\u03b7\u03bc\u03b1\u03c4\u03af\u03c3\u03bf\u03c5\u03bc\u03b5 \u03bc\u03b9\u03b1 \u03b5\u03b9\u03ba\u03cc\u03bd\u03b1 \u03b3\u03b9\u03b1 \u03c4\u03b7 \u03b4\u03b7\u03bc\u03b9\u03bf\u03c5\u03c1\u03b3\u03af\u03b1 \u03c4\u03bf\u03c5 \u03bf\u03b4\u03b7\u03b3\u03bf\u03cd PIC\/S GMP. <\/p>\n\n\n\n

    \u03a4\u03bf \u03c0\u03b1\u03c1\u03ac\u03c1\u03c4\u03b7\u03bc\u03b1 1 \u03b4\u03b7\u03bc\u03bf\u03c3\u03b9\u03b5\u03cd\u03b8\u03b7\u03ba\u03b5 \u03b1\u03c1\u03c7\u03b9\u03ba\u03ac \u03c4\u03bf 1971 \u03ba\u03b1\u03b9 \u03c5\u03c0\u03ad\u03c3\u03c4\u03b7 \u03c0\u03bf\u03bb\u03bb\u03b1\u03c0\u03bb\u03ad\u03c2 \u03b1\u03bb\u03bb\u03b1\u03b3\u03ad\u03c2, \u03b5\u03bd\u03ce \u03c3\u03c4\u03b1 \u03c4\u03ad\u03bb\u03b7 \u03c4\u03bf\u03c5 2017 \u03b4\u03b7\u03bc\u03bf\u03c3\u03b9\u03b5\u03cd\u03b8\u03b7\u03ba\u03b5 \u03c4\u03bf \u03c0\u03c1\u03ce\u03c4\u03bf \u03c3\u03c7\u03ad\u03b4\u03b9\u03bf \u03bc\u03b9\u03b1\u03c2 \u03c3\u03b7\u03bc\u03b1\u03bd\u03c4\u03b9\u03ba\u03ae\u03c2 \u03b1\u03bd\u03b1\u03b8\u03b5\u03ce\u03c1\u03b7\u03c3\u03b7\u03c2.  \u039c\u03b5\u03c4\u03b1\u03be\u03cd \u03c4\u03bf\u03c5 2017 \u03ba\u03b1\u03b9 \u03c4\u03bf\u03c5 2023 \u03bf\u03b9 \u03b1\u03bb\u03bb\u03b1\u03b3\u03ad\u03c2 \u03c3\u03c4\u03b7 \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03bf\u03b2\u03b9\u03bf\u03bc\u03b7\u03c7\u03b1\u03bd\u03af\u03b1 \u03ae\u03c4\u03b1\u03bd \u03c4\u03cc\u03c3\u03bf \u03c3\u03b7\u03bc\u03b1\u03bd\u03c4\u03b9\u03ba\u03ad\u03c2 \u03c0\u03bf\u03c5 \u03b7 \u03bf\u03bc\u03ac\u03b4\u03b1 \u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1\u03c2 \u03c4\u03c9\u03bd \u03b5\u03c0\u03b9\u03b8\u03b5\u03c9\u03c1\u03b7\u03c4\u03ce\u03bd GMP\/GDP \u03ba\u03b1\u03b9 \u03b7 \u03b5\u03c0\u03b9\u03c4\u03c1\u03bf\u03c0\u03ae PIC\/S \u03c3\u03c5\u03bd\u03ad\u03c3\u03c4\u03b7\u03c3\u03b1\u03bd \u03b1\u03c0\u03cc \u03ba\u03bf\u03b9\u03bd\u03bf\u03cd \u03c4\u03b7\u03bd \u03b1\u03bd\u03b1\u03b8\u03b5\u03ce\u03c1\u03b7\u03c3\u03b7 \u03c4\u03bf\u03c5 \u03c0\u03b1\u03c1\u03b1\u03c1\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 1.  \u0397 \u03b1\u03bd\u03b1\u03b8\u03b5\u03c9\u03c1\u03b7\u03bc\u03ad\u03bd\u03b7 \u03ba\u03b1\u03c4\u03b5\u03c5\u03b8\u03c5\u03bd\u03c4\u03ae\u03c1\u03b9\u03b1 \u03b3\u03c1\u03b1\u03bc\u03bc\u03ae \u03c4\u03bf\u03c5 \u03a0\u03b1\u03c1\u03b1\u03c1\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 1 \u03c0\u03c1\u03bf\u03c3\u03b1\u03c1\u03bc\u03cc\u03b6\u03b5\u03c4\u03b1\u03b9 \u03c3\u03c4\u03b7 \u03bc\u03b5\u03c4\u03b1\u03b2\u03bf\u03bb\u03ae \u03c4\u03c9\u03bd \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03ce\u03bd \u03ba\u03b1\u03b9 \u03b8\u03b5\u03c1\u03b1\u03c0\u03b5\u03c5\u03c4\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03bc\u03b1\u03b6\u03af \u03bc\u03b5 \u03c4\u03b1 \u03bd\u03ad\u03b1 \u03b5\u03be\u03b1\u03c4\u03bf\u03bc\u03b9\u03ba\u03b5\u03c5\u03bc\u03ad\u03bd\u03b1 \u03c6\u03ac\u03c1\u03bc\u03b1\u03ba\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b9\u03c2 \u03c0\u03c1\u03bf\u03b7\u03b3\u03bc\u03ad\u03bd\u03b5\u03c2 \u03b8\u03b5\u03c1\u03b1\u03c0\u03b5\u03af\u03b5\u03c2.  \u0395\u03bd \u03bf\u03bb\u03af\u03b3\u03bf\u03b9\u03c2, \u03c4\u03bf \u03c0\u03b1\u03c1\u03ac\u03c1\u03c4\u03b7\u03bc\u03b1 1 \u03b1\u03c5\u03be\u03ae\u03b8\u03b7\u03ba\u03b5 \u03b1\u03c0\u03cc 16 \u03c3\u03b5 56 \u03c3\u03b5\u03bb\u03af\u03b4\u03b5\u03c2. \u03a0\u03c1\u03cc\u03ba\u03b5\u03b9\u03c4\u03b1\u03b9 \u03b3\u03b9\u03b1 \u03bc\u03b9\u03b1 \u03c3\u03b7\u03bc\u03b1\u03bd\u03c4\u03b9\u03ba\u03ae \u03b1\u03bd\u03b1\u03b8\u03b5\u03ce\u03c1\u03b7\u03c3\u03b7 \u03b3\u03b9\u03b1 \u03bd\u03b1 \u03c3\u03c5\u03bc\u03b2\u03b1\u03b4\u03af\u03c3\u03b5\u03b9 \u03bc\u03b5 \u03c4\u03b9\u03c2 \u03b1\u03bb\u03bb\u03b1\u03b3\u03ad\u03c2 \u03c3\u03c4\u03bf\u03bd \u03ba\u03bb\u03ac\u03b4\u03bf.  <\/p>\n\n\n\n

    FDA, MHRA \u03ba\u03b1\u03b9 PIC\/S – \u039f\u03bc\u03b1\u03b4\u03b9\u03ba\u03ae \u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03c3\u03c4\u03b1 \u03ba\u03b1\u03bb\u03cd\u03c4\u03b5\u03c1\u03ac \u03c4\u03b7\u03c2<\/h3>\n\n\n\n

    \u039c\u03b9\u03b1 \u03b5\u03c1\u03ce\u03c4\u03b7\u03c3\u03b7 \u03c0\u03bf\u03c5 \u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03bf\u03c5\u03bc\u03b5 \u03c0\u03bf\u03bb\u03cd \u03c3\u03c5\u03c7\u03bd\u03ac… \u03bc\u03c0\u03bf\u03c1\u03b5\u03af \u03bf FDA \u03bd\u03b1 \u03b5\u03c0\u03b9\u03b2\u03ac\u03bb\u03b5\u03b9 \u03c4\u03b9\u03c2 \u03bd\u03ad\u03b5\u03c2 \u03b1\u03bd\u03b1\u03b8\u03b5\u03c9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03bf\u03c5 \u03c0\u03b1\u03c1\u03b1\u03c1\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 1;  \u0397 \u03b1\u03c0\u03bb\u03ae \u03b1\u03c0\u03ac\u03bd\u03c4\u03b7\u03c3\u03b7 \u03b5\u03af\u03bd\u03b1\u03b9 \u03cc\u03c7\u03b9, \u03bf FDA \u03b5\u03c0\u03b1\u03bd\u03b5\u03be\u03b5\u03c4\u03ac\u03b6\u03b5\u03b9 \u03ba\u03b1\u03b9 \u03b1\u03bd\u03c4\u03bb\u03b5\u03af \u03bc\u03cc\u03bd\u03bf \u03b1\u03c0\u03cc \u03c4\u03bf\u03bd \u039a\u03ce\u03b4\u03b9\u03ba\u03b1 \u039f\u03bc\u03bf\u03c3\u03c0\u03bf\u03bd\u03b4\u03b9\u03b1\u03ba\u03ce\u03bd \u039a\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03bc\u03ce\u03bd (CFR).  \u0397 \u03bc\u03b5\u03b3\u03b1\u03bb\u03cd\u03c4\u03b5\u03c1\u03b7 \u03b1\u03c0\u03ac\u03bd\u03c4\u03b7\u03c3\u03b7 \u03b5\u03af\u03bd\u03b1\u03b9 “\u03cc\u03c0\u03bf\u03c5 \u03c5\u03c0\u03ac\u03c1\u03c7\u03b5\u03b9 \u03c0\u03b1\u03c1\u03b1\u03b2\u03af\u03b1\u03c3\u03b7 \u03c5\u03c0\u03ac\u03c1\u03c7\u03b5\u03b9 \u03ba\u03b1\u03b9 \u03c4\u03c1\u03cc\u03c0\u03bf\u03c2”.  \u039c\u03b5 \u03c4\u03b7\u03bd PIC\/S \u03bd\u03b1 \u03b4\u03b7\u03bc\u03b9\u03bf\u03c5\u03c1\u03b3\u03b5\u03af \u03ad\u03bd\u03b1 \u03ba\u03bf\u03b9\u03bd\u03cc \u03ad\u03b4\u03b1\u03c6\u03bf\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b9\u03c2 56 \u03b4\u03b9\u03b1\u03c6\u03bf\u03c1\u03b5\u03c4\u03b9\u03ba\u03ad\u03c2 \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c1\u03c7\u03ad\u03c2 \u03ba\u03b1\u03b9 \u03bd\u03b1 \u03b5\u03c0\u03b9\u03c4\u03c1\u03ad\u03c0\u03b5\u03b9 \u03c4\u03b7\u03bd \u03b1\u03bc\u03bf\u03b9\u03b2\u03b1\u03af\u03b1 \u03b5\u03bc\u03c0\u03b9\u03c3\u03c4\u03bf\u03c3\u03cd\u03bd\u03b7 \u03bc\u03b5\u03c4\u03b1\u03be\u03cd \u03c4\u03bf\u03c5\u03c2, \u03b8\u03b1 \u03c0\u03c1\u03ad\u03c0\u03b5\u03b9 \u03bd\u03b1 \u03b1\u03bd\u03b1\u03bc\u03ad\u03bd\u03bf\u03c5\u03bc\u03b5 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03bc\u03b5\u03c4\u03b1\u03be\u03cd \u03c4\u03c9\u03bd \u03bf\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03ce\u03bd. <\/p>\n\n\n\n

    \u03a4\u03cc\u03c3\u03bf \u03bf FDA \u03cc\u03c3\u03bf \u03ba\u03b1\u03b9 \u03bf MHRA \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03bf\u03cd\u03bd, \u03b5\u03c0\u03b9\u03b8\u03b5\u03c9\u03c1\u03bf\u03cd\u03bd \u03ba\u03b1\u03b9 \u03c0\u03b1\u03c1\u03b1\u03c0\u03ad\u03bc\u03c0\u03bf\u03c5\u03bd \u03c4\u03b9\u03c2 \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b5\u03b3\u03ba\u03b1\u03c4\u03b1\u03c3\u03c4\u03ac\u03c3\u03b5\u03b9\u03c2. \u0397 PIC\/S \u03b4\u03b5\u03bd \u03b5\u03ba\u03c4\u03b5\u03bb\u03b5\u03af \u03ba\u03b1\u03bc\u03af\u03b1 \u03b1\u03c0\u03cc \u03b1\u03c5\u03c4\u03ad\u03c2 \u03c4\u03b9\u03c2 \u03bb\u03b5\u03b9\u03c4\u03bf\u03c5\u03c1\u03b3\u03af\u03b5\u03c2. \u0397 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03bc\u03b5\u03c4\u03b1\u03be\u03cd MHRA \u03ba\u03b1\u03b9 FDA \u03ad\u03c7\u03b5\u03b9 \u03b3\u03af\u03bd\u03b5\u03b9 \u03c0\u03b9\u03bf \u03c3\u03c4\u03b5\u03bd\u03ae \u03ba\u03b1\u03b9 \u03c0\u03b9\u03bf \u03b5\u03bc\u03c6\u03b1\u03bd\u03ae\u03c2 \u03c4\u03b1 \u03c4\u03b5\u03bb\u03b5\u03c5\u03c4\u03b1\u03af\u03b1 \u03c7\u03c1\u03cc\u03bd\u03b9\u03b1. \u03a3\u03b5 \u03c0\u03bf\u03bb\u03bb\u03ac \u03b1\u03c0\u03cc \u03c4\u03b1 \u03c0\u03c1\u03cc\u03c3\u03c6\u03b1\u03c4\u03b1 \u03c3\u03c5\u03bd\u03ad\u03b4\u03c1\u03b9\u03b1, \u03c3\u03b7\u03bc\u03b5\u03b9\u03ce\u03bd\u03b5\u03c4\u03b1\u03b9 \u03cc\u03c4\u03b9 \u03b7 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03b1\u03c5\u03c4\u03ae \u03b3\u03af\u03bd\u03b5\u03c4\u03b1\u03b9 \u03cc\u03bb\u03bf \u03ba\u03b1\u03b9 \u03c0\u03b9\u03bf \u03b9\u03c3\u03c7\u03c5\u03c1\u03ae. \u03a0\u03bf\u03cd \u03b5\u03bd\u03c4\u03ac\u03c3\u03c3\u03b5\u03c4\u03b1\u03b9 \u03bb\u03bf\u03b9\u03c0\u03cc\u03bd \u03b7 PIC\/S \u03c3\u03b5 \u03b1\u03c5\u03c4\u03cc \u03c4\u03bf \u03c0\u03bb\u03b1\u03af\u03c3\u03b9\u03bf; \u039b\u03bf\u03b9\u03c0\u03cc\u03bd, \u03b7 PIC\/S \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03ba\u03bf\u03b9\u03bd\u03cc \u03bd\u03ae\u03bc\u03b1 \u03bc\u03b5\u03c4\u03b1\u03be\u03cd \u03c4\u03cc\u03c3\u03c9\u03bd \u03c0\u03bf\u03bb\u03bb\u03ce\u03bd \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03c4\u03b9\u03ba\u03ce\u03bd \u03b1\u03c1\u03c7\u03ce\u03bd. \u03a7\u03c1\u03b7\u03c3\u03b9\u03bc\u03b5\u03cd\u03bf\u03c5\u03bd \u03c0\u03c1\u03b1\u03b3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ac \u03c9\u03c2 \u03ad\u03bd\u03b1\u03c2 \u03ac\u03bb\u03bb\u03bf\u03c2 \u03c3\u03cd\u03bd\u03b4\u03b5\u03c3\u03bc\u03bf\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03c0\u03b1\u03b3\u03ba\u03cc\u03c3\u03bc\u03b9\u03b1 \u03bf\u03bc\u03b1\u03b4\u03b9\u03ba\u03ae \u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1. <\/p>\n\n\n\n

    \u039c\u03b5\u03bb\u03bb\u03bf\u03bd\u03c4\u03b9\u03ba\u03cc<\/h3>\n\n\n\n

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