{"id":8263,"date":"2024-05-29T11:47:52","date_gmt":"2024-05-29T03:47:52","guid":{"rendered":"https:\/\/greenoo.tw\/?p=8263"},"modified":"2026-01-08T15:49:24","modified_gmt":"2026-01-08T07:49:24","slug":"fda-cosmetic-gmp-guidance-taiwan-manufacturer-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda-cosmetic-gmp-guidance-taiwan-manufacturer-2026\/","title":{"rendered":"\u3010\u7da0\u5708\u5708\u8aaa\u8de8\u5883\u3011\u7f8e\u570bFDA\u95dc\u65bc\u5316\u599d\u54c1GMP\u7684\u6307\u5c0e\u610f\u898b\uff082026\u6700\u65b0\uff09"},"content":{"rendered":"<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-19368\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-cosmetic-gmp-guidance-feature-2026.png\" alt=\"\u7f8e\u570bFDA\u5316\u599d\u54c1GMP\u6307\u5c0e\u610f\u898b\u5c01\u9762\uff0c\u986f\u793a\u5de5\u5ee0\u751f\u7522\u7dda\u5716\u793a\u82072026\u6700\u65b0\u5408\u898f\u89e3\u6790\uff0c\u6a19\u8a3b\u975e\u5f37\u5236\u6027\u81ea\u9858\u9075\u5faa\u7279\u6027\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-cosmetic-gmp-guidance-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-cosmetic-gmp-guidance-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-cosmetic-gmp-guidance-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-cosmetic-gmp-guidance-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-cosmetic-gmp-guidance-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\n<h2>FDA\u5316\u599d\u54c1GMP\u662f\u5f37\u5236\u8981\u6c42\u55ce\uff1f\u53f0\u7063\u5de5\u5ee0\u5fc5\u9808\u4e86\u89e3\u7684\u95dc\u9375\u5dee\u7570<\/h2>\n<p><strong>\u4e0d\uff0cFDA\u5316\u599d\u54c1GMP\u76ee\u524d\u4e0d\u662f\u5f37\u5236\u6027\u6cd5\u898f\u8981\u6c42\uff0c\u800c\u662f\u81ea\u9858\u9075\u5faa\u7684\u6307\u5c0e\u610f\u898b\u3002<\/strong> \u6839\u64da <a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-guidance-regulation\/draft-guidance-industry-good-manufacturing-practice-gmps-cosmetics\" target=\"_blank\" rel=\"noopener\">FDA\u5b98\u65b9\u5316\u599d\u54c1GMP\u6307\u5c0e\u6587\u4ef6<\/a>{:target=&#8221;_blank&#8221;}\uff0cFDA\u63d0\u4f9b\u7684GMP\u6307\u5357\u5c6c\u65bc\u300c\u975e\u7d04\u675f\u6027\u5efa\u8b70\u300d\uff08non-binding recommendations\uff09\uff0c\u8207\u85e5\u54c1\u6216\u98df\u54c1\u7684\u5f37\u5236\u6027GMP\u4e0d\u540c\u3002\u7136\u800c\uff0c\u9019\u4e0d\u4ee3\u8868\u53f0\u7063\u5de5\u5ee0\u53ef\u4ee5\u5ffd\u8996GMP\uff0c\u56e0\u70ba\uff1a<\/p>\n<ul>\n<li><strong>MoCRA\u6cd5\u898f\u5f37\u5316\u54c1\u8cea\u8981\u6c42<\/strong>\uff1a2022\u5e74\u901a\u904e\u7684MoCRA\u6cd5\u6848\u96d6\u672a\u5f37\u5236GMP\uff0c\u4f46\u8981\u6c42\u5316\u599d\u54c1\u5fc5\u9808\u7b26\u5408\u300c\u5b89\u5168\u6a19\u6e96\u300d\uff0c\u5be6\u52d9\u4e0a\u9700\u900f\u904e\u826f\u597d\u88fd\u9020\u898f\u7bc4\u9054\u6210<\/li>\n<li><strong>\u5e02\u5834\u7af6\u722d\u529b\u8003\u91cf<\/strong>\uff1a\u7f8e\u570b\u5927\u578b\u96f6\u552e\u5546\uff08\u5982Sephora\u3001Ulta\uff09\u8207\u96fb\u5546\u5e73\u53f0\uff08Amazon\uff09\u591a\u8981\u6c42\u4f9b\u61c9\u5546\u63d0\u4f9bGMP\u8b49\u660e<\/li>\n<li><strong>\u7522\u54c1\u8cac\u4efb\u98a8\u96aa<\/strong>\uff1a\u82e5\u7522\u54c1\u51fa\u73fe\u54c1\u8cea\u554f\u984c\u5c0e\u81f4\u6d88\u8cbb\u8005\u50b7\u5bb3\uff0c\u7f3a\u4e4fGMP\u7d00\u9304\u5c07\u6210\u70ba\u8a34\u8a1f\u4e0d\u5229\u8b49\u64da<\/li>\n<\/ul>\n<p>\u9019\u4f7f\u5f97\u300c\u81ea\u9858\u4f46\u5fc5\u8981\u300d\u6210\u70baFDA\u5316\u599d\u54c1GMP\u7684\u5be6\u52d9\u5b9a\u4f4d\uff0c\u53f0\u7063\u5916\u8cbf\u5de5\u5ee0\u9700\u6b63\u78ba\u7406\u89e3\u5176\u6cd5\u5f8b\u5730\u4f4d\u8207\u5546\u696d\u50f9\u503c\u3002<\/p>\n<hr \/>\n<h2>\u70ba\u4ec0\u9ebcFDA\u4e0d\u5f37\u5236\u5316\u599d\u54c1GMP\uff1f\u6cd5\u898f\u80cc\u666f\u8207\u6f14\u8b8a<\/h2>\n<h3>FDA\u5316\u599d\u54c1\u76e3\u7ba1\u7684\u6b77\u53f2\u5b9a\u4f4d<\/h3>\n<p>FDA\u5c0d\u5316\u599d\u54c1\u7684\u76e3\u7ba1\u6b0a\u9650\u6e90\u81ea1938\u5e74\u300a\u806f\u90a6\u98df\u54c1\u3001\u85e5\u54c1\u548c\u5316\u599d\u54c1\u6cd5\u300b\uff08FD&amp;C Act\uff09\uff0c\u4f46\u8a72\u6cd5\u6848\u8ce6\u4e88FDA\u7684\u5316\u599d\u54c1\u7ba1\u7406\u6b0a\u9650\u9060\u4f4e\u65bc\u85e5\u54c1\u6216\u98df\u54c1\u3002\u4f9d\u64da <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-G\/part-700\" target=\"_blank\" rel=\"noopener\">CFR Title 21 Part 700<\/a>{:target=&#8221;_blank&#8221;}\uff0cFDA\u50c5\u80fd\uff1a<\/p>\n<ul>\n<li>\u8981\u6c42\u5316\u599d\u54c1\u4e0d\u5f97\u647b\u5047\uff08adulterated\uff09\u6216\u6a19\u793a\u4e0d\u5be6\uff08misbranded\uff09<\/li>\n<li>\u7981\u6b62\u4f7f\u7528\u7279\u5b9a\u6709\u5bb3\u6210\u5206<\/li>\n<li>\u4e0a\u5e02\u5f8c\u76e3\u6e2c\u8207\u53ec\u56de\u4e0d\u5b89\u5168\u7522\u54c1<\/li>\n<\/ul>\n<p>\u4f46FDA\u7121\u6b0a\u8981\u6c42\u5316\u599d\u54c1\u4e0a\u5e02\u524d\u5be9\u6279\u6216\u5f37\u5236\u57f7\u884c\u751f\u7522\u6a19\u6e96\uff0c\u9019\u8207\u6b50\u76df\u7684\u9810\u5148\u5be9\u67e5\u5236\u5ea6\u5f62\u6210\u9bae\u660e\u5c0d\u6bd4\u3002\u56e0\u6b64\uff0cFDA\u9078\u64c7\u767c\u5e03\u300c\u6307\u5c0e\u610f\u898b\u300d\u800c\u975e\u300c\u5f37\u5236\u6cd5\u898f\u300d\uff0c\u9f13\u52f5\u696d\u8005\u81ea\u4e3b\u63a1\u7528GMP\u3002<\/p>\n<h3>MoCRA\u6cd5\u6848\u5e36\u4f86\u7684\u8b8a\u5316<\/h3>\n<p><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra\" target=\"_blank\" rel=\"noopener\">MoCRA\u6cd5\u6848<\/a>{:target=&#8221;_blank&#8221;}\u65bc2022\u5e7412\u6708\u7c3d\u7f72\u751f\u6548\uff0c\u9996\u6b21\u8ce6\u4e88FDA\u66f4\u591a\u5316\u599d\u54c1\u76e3\u7ba1\u6b0a\u529b\uff0c\u5305\u62ec\u8a2d\u65bd\u8a3b\u518a\u3001\u7522\u54c1\u5217\u8868\u3001\u4e0d\u826f\u4e8b\u4ef6\u5f37\u5236\u7533\u5831\u7b49\u3002\u96d6\u7136MoCRA\u672a\u76f4\u63a5\u5f37\u5236GMP\uff0c\u4f46\u6cd5\u6848\u7b2c612\u689d\u8981\u6c42\u5316\u599d\u54c1\u300c\u4e0d\u5f97\u647b\u5047\u300d\uff0c\u5be6\u52d9\u4e0a\u9700\u900f\u904e\u826f\u597d\u88fd\u9020\u5be6\u52d9\u8b49\u660e\u7522\u54c1\u5b89\u5168\u6027\u3002<\/p>\n<p>\u5b8c\u6574\u7684MoCRA\u6cd5\u898f\u5f71\u97ff\u8acb\u53c3\u8003\u6211\u5011\u7684 <a href=\"https:\/\/greenoo.tw\/zh\/mocra-fda-cosmetic-registration-guide\/\" target=\"_blank\" rel=\"noopener\">MoCRA\u6cd5\u898f\u4e0a\u8def\u5f8c\uff0cFDA\u5316\u599d\u54c1\u8a3b\u518a\u5236\u5ea6\u5b8c\u6574\u89e3\u6790<\/a>\u3002<\/p>\n<hr \/>\n<h2>FDA\u5316\u599d\u54c1GMP\u6307\u5c0e\u610f\u898b\u6838\u5fc3\u5167\u5bb9\uff1a5\u5927\u7ba1\u7406\u8981\u7d20<\/h2>\n<h3>\u8981\u7d201\uff1a\u4eba\u54e1\u7ba1\u7406\uff08Personnel\uff09<\/h3>\n<p><strong>\u6838\u5fc3\u8981\u6c42<\/strong>\uff1a<\/p>\n<ul>\n<li>\u751f\u7522\u8207\u54c1\u7ba1\u4eba\u54e1\u9700\u5177\u5099\u9069\u7576\u8a13\u7df4\u8207\u8cc7\u683c<\/li>\n<li>\u5efa\u7acb\u5065\u5eb7\u76e3\u6e2c\u6a5f\u5236\uff0c\u907f\u514d\u75be\u75c5\u6c61\u67d3\u7522\u54c1<\/li>\n<li>\u660e\u78ba\u8077\u8cac\u5283\u5206\uff0c\u907f\u514d\u89d2\u8272\u885d\u7a81<\/li>\n<\/ul>\n<p><strong>\u53f0\u7063\u5de5\u5ee0\u5be6\u52d9\u61c9\u7528<\/strong>\uff1a<br \/>\n\u8a31\u591a\u53f0\u7063\u4ee3\u5de5\u5ee0\u5df2\u6709ISO 9001\u6216ISO 22716\u8a8d\u8b49\uff0c\u4eba\u54e1\u7ba1\u7406\u67b6\u69cb\u53ef\u76f4\u63a5\u5c0d\u61c9FDA\u8981\u6c42\u3002\u95dc\u9375\u662f\u5efa\u7acb\u82f1\u6587\u7248\u8a13\u7df4\u7d00\u9304\uff0c\u4fbf\u65bc\u7f8e\u570b\u5ba2\u6236\u7a3d\u6838\u3002<\/p>\n<h3>\u8981\u7d202\uff1a\u5ee0\u623f\u8207\u8a2d\u65bd\uff08Plant and Grounds\uff09<\/h3>\n<p><strong>\u6838\u5fc3\u8981\u6c42<\/strong>\uff1a<\/p>\n<ul>\n<li>\u751f\u7522\u5340\u57df\u9700\u8207\u975e\u751f\u7522\u5340\u57df\u660e\u78ba\u5340\u9694<\/li>\n<li>\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\uff08\u5982\u9999\u7cbe\u3001\u8272\u6599\uff09<\/li>\n<li>\u9069\u7576\u7684\u901a\u98a8\u3001\u7167\u660e\u3001\u6eab\u6fd5\u5ea6\u63a7\u5236<\/li>\n<\/ul>\n<p><strong>\u53f0\u7063\u5de5\u5ee0\u5be6\u52d9\u61c9\u7528<\/strong>\uff1a<br \/>\n\u5f69\u599d\u8207\u8b77\u819a\u54c1\u751f\u7522\u7dda\u61c9\u5206\u958b\uff0c\u907f\u514d\u8272\u6599\u6b98\u7559\u3002\u82e5\u5de5\u5ee0\u540c\u6642\u751f\u7522\u5316\u599d\u54c1\u8207\u975e\u5316\u599d\u54c1\uff08\u5982\u6e05\u6f54\u5291\uff09\uff0c\u9700\u6709\u5be6\u9ad4\u9694\u96e2\u63aa\u65bd\u3002<\/p>\n<h3>\u8981\u7d203\uff1a\u8a2d\u5099\u8207\u5668\u5177\uff08Equipment and Utensils\uff09<\/h3>\n<p><strong>\u6838\u5fc3\u8981\u6c42<\/strong>\uff1a<\/p>\n<ul>\n<li>\u8a2d\u5099\u6750\u8cea\u4e0d\u5f97\u8207\u7522\u54c1\u767c\u751f\u5316\u5b78\u53cd\u61c9<\/li>\n<li>\u5efa\u7acb\u6e05\u6f54\u8207\u6d88\u6bd2\u6a19\u6e96\u4f5c\u696d\u7a0b\u5e8f\uff08SOP\uff09<\/li>\n<li>\u5b9a\u671f\u6821\u6b63\u6e2c\u91cf\u5100\u5668<\/li>\n<\/ul>\n<p><strong>\u53f0\u7063\u5de5\u5ee0\u5be6\u52d9\u61c9\u7528<\/strong>\uff1a<br \/>\n\u4e0d\u93fd\u92fc\u8a2d\u5099\u512a\u65bc\u5851\u81a0\u5bb9\u5668\uff0c\u907f\u514d\u5851\u5316\u5291\u6eb6\u51fa\u3002\u5efa\u8b70\u5efa\u7acb\u300c\u8a2d\u5099\u6e05\u6f54\u9a57\u8b49\u7d00\u9304\u300d\uff0c\u8b49\u660e\u4e0d\u540c\u6279\u6b21\u9593\u7121\u4ea4\u53c9\u6c61\u67d3\u3002<\/p>\n<h3>\u8981\u7d204\uff1a\u751f\u7522\u8207\u88fd\u7a0b\u7ba1\u5236\uff08Production and Process Controls\uff09<\/h3>\n<p><strong>\u6838\u5fc3\u8981\u6c42<\/strong>\uff1a<\/p>\n<ul>\n<li>\u5efa\u7acb\u6279\u6b21\u7d00\u9304\u7cfb\u7d71\uff0c\u53ef\u8ffd\u6eaf\u539f\u6599\u81f3\u6210\u54c1<\/li>\n<li>\u95dc\u9375\u88fd\u7a0b\u53c3\u6578\u9700\u76e3\u63a7\uff08\u5982\u4e73\u5316\u6eab\u5ea6\u3001pH\u503c\uff09<\/li>\n<li>\u7559\u6a23\u4fdd\u5b58\uff0c\u4fbf\u65bc\u54c1\u8cea\u8ffd\u8e64<\/li>\n<\/ul>\n<p><strong>\u53f0\u7063\u5de5\u5ee0\u5be6\u52d9\u61c9\u7528<\/strong>\uff1a<br \/>\n\u9019\u662fFDA\u7a3d\u6838\u6700\u5e38\u6aa2\u67e5\u7684\u9805\u76ee\u3002\u5efa\u8b70\u4f7f\u7528ERP\u7cfb\u7d71\u7ba1\u7406\u6279\u6b21\u865f\u78bc\uff0c\u4e26\u4fdd\u7559\u81f3\u5c113\u5e74\u7d00\u9304\uff08\u5c0d\u61c9\u7f8e\u570b\u7522\u54c1\u8cac\u4efb\u8a34\u8a1f\u6642\u6548\uff09\u3002<\/p>\n<h3>\u8981\u7d205\uff1a\u5be6\u9a57\u5ba4\u7ba1\u5236\uff08Laboratory Controls\uff09<\/h3>\n<p><strong>\u6838\u5fc3\u8981\u6c42<\/strong>\uff1a<\/p>\n<ul>\n<li>\u539f\u6599\u9032\u6599\u6aa2\u9a57\uff08\u5982\u5fae\u751f\u7269\u3001\u91cd\u91d1\u5c6c\uff09<\/li>\n<li>\u534a\u6210\u54c1\u8207\u6210\u54c1\u54c1\u8cea\u6e2c\u8a66<\/li>\n<li>\u7a69\u5b9a\u6027\u6e2c\u8a66\uff08\u4fdd\u5b58\u671f\u9650\u9a57\u8b49\uff09<\/li>\n<\/ul>\n<p><strong>\u53f0\u7063\u5de5\u5ee0\u5be6\u52d9\u61c9\u7528<\/strong>\uff1a<br \/>\n\u82e5\u5de5\u5ee0\u7121\u81ea\u6709\u5be6\u9a57\u5ba4\uff0c\u53ef\u59d4\u5916\u6aa2\u6e2c\uff0c\u4f46\u9700\u4fdd\u7559\u5b8c\u6574\u6aa2\u9a57\u5831\u544a\u3002\u5fae\u751f\u7269\u6e2c\u8a66\uff08\u5982\u7e3d\u751f\u83cc\u6578\u3001\u5927\u8178\u687f\u83cc\uff09\u662f\u6700\u4f4e\u8981\u6c42\u3002<\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<h2>FDA GMP vs \u6b50\u76dfISO 22716\uff1a\u53f0\u7063\u5de5\u5ee0\u8a72\u9078\u64c7\u54ea\u4e00\u500b\uff1f<\/h2>\n<h3>\u5169\u5957\u6a19\u6e96\u7684\u6838\u5fc3\u5dee\u7570<\/h3>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>\u6bd4\u8f03\u9805\u76ee<\/th>\n<th>FDA GMP \u6307\u5c0e\u610f\u898b<\/th>\n<th>\u6b50\u76df ISO 22716<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u6cd5\u5f8b\u5730\u4f4d<\/strong><\/td>\n<td>\u81ea\u9858\u9075\u5faa\uff0c\u975e\u5f37\u5236<\/td>\n<td>\u6b50\u76df\u5e02\u5834\u5f37\u5236\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td><strong>\u8a8d\u8b49\u6a5f\u5236<\/strong><\/td>\n<td>\u7121\u5b98\u65b9\u8a8d\u8b49\uff0c\u9760\u81ea\u6211\u8072\u660e<\/td>\n<td>\u9700\u7b2c\u4e09\u65b9\u8a8d\u8b49\u6a5f\u69cb\u7a3d\u6838<\/td>\n<\/tr>\n<tr>\n<td><strong>\u6587\u4ef6\u8981\u6c42<\/strong><\/td>\n<td>\u5efa\u8b70\u5efa\u7acb\uff0c\u7121\u7279\u5b9a\u683c\u5f0f<\/td>\n<td>\u5f37\u5236\u8981\u6c42\u8a73\u7d30\u6587\u4ef6\u5316<\/td>\n<\/tr>\n<tr>\n<td><strong>\u9069\u7528\u5e02\u5834<\/strong><\/td>\n<td>\u7f8e\u570b\u5e02\u5834\u52a0\u5206\u9805<\/td>\n<td>\u6b50\u76df\u3001\u82f1\u570b\u3001\u90e8\u5206\u4e9e\u6d32\u5e02\u5834\u5fc5\u5099<\/td>\n<\/tr>\n<tr>\n<td><strong>\u7a3d\u6838\u983b\u7387<\/strong><\/td>\n<td>\u50c5\u5728FDA\u8abf\u67e5\u6642\u6aa2\u67e5<\/td>\n<td>\u6bcf\u5e74\u6216\u6bcf\u4e09\u5e74\u5b9a\u671f\u7a3d\u6838<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h3>\u53f0\u7063\u5de5\u5ee0\u7684\u5be6\u52d9\u9078\u64c7\u7b56\u7565<\/h3>\n<p><strong>\u60c5\u58831\uff1a\u4e3b\u8981\u51fa\u53e3\u7f8e\u570b\u5e02\u5834<\/strong><\/p>\n<ul>\n<li>\u512a\u5148\u5efa\u7acb\u7b26\u5408FDA GMP\u7684\u5167\u90e8\u7ba1\u7406\u5236\u5ea6<\/li>\n<li>\u7121\u9700\u82b1\u8cbb\u8a8d\u8b49\u8cbb\u7528\uff0c\u4f46\u9700\u5b8c\u6574\u7d00\u9304\u5099\u67e5<\/li>\n<li>\u5efa\u8b70\u53c3\u8003ISO 22716\u67b6\u69cb\uff0c\u63d0\u5347\u7ba1\u7406\u6c34\u6e96<\/li>\n<\/ul>\n<p><strong>\u60c5\u58832\uff1a\u540c\u6642\u51fa\u53e3\u7f8e\u570b\u8207\u6b50\u76df<\/strong><\/p>\n<ul>\n<li>\u76f4\u63a5\u53d6\u5f97ISO 22716\u8a8d\u8b49\uff08\u6db5\u84cbFDA\u8981\u6c42\uff09<\/li>\n<li>\u8a8d\u8b49\u8cbb\u7528\u7d0415-30\u842c\u53f0\u5e63\uff0c\u4f46\u53ef\u540c\u6642\u6eff\u8db3\u5169\u500b\u5e02\u5834<\/li>\n<li>\u7f8e\u570b\u5ba2\u6236\u666e\u904d\u63a5\u53d7ISO 22716\u4f5c\u70baGMP\u8b49\u660e<\/li>\n<\/ul>\n<p><strong>\u60c5\u58833\uff1a\u50c5\u63a5ODM\u8a02\u55ae\uff0c\u4e0d\u76f4\u63a5\u51fa\u53e3<\/strong><\/p>\n<ul>\n<li>\u7531\u54c1\u724c\u5546\u6c7a\u5b9a\u662f\u5426\u9700\u8981GMP\u8b49\u660e<\/li>\n<li>\u5efa\u8b70\u81f3\u5c11\u5efa\u7acb\u57fa\u790e\u6279\u6b21\u7d00\u9304\u8207\u54c1\u7ba1\u6587\u4ef6<\/li>\n<li>\u53ef\u4f5c\u70ba\u672a\u4f86\u53d6\u5f97\u8a8d\u8b49\u7684\u6e96\u5099\u57fa\u790e<\/li>\n<\/ul>\n<p>\u5b8c\u6574\u7684\u5408\u898f\u7b56\u7565\u898f\u5283\u8acb\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/zh\/taiwan-seller-fda-cosmetic-compliance-guide\/\" target=\"_blank\" rel=\"noopener\">\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u51fa\u53e3\u7f8e\u570bFDA\u5316\u599d\u54c1\u5408\u898f\u5168\u6307\u5357<\/a>\u3002<\/p>\n<hr \/>\n<h2>\u53f0\u7063\u5de5\u5ee0\u5be6\u65bdFDA GMP\u76843\u500b\u5e38\u898b\u8aa4\u5340<\/h2>\n<h3>\u8aa4\u53401\uff1a\u300cFDA\u6c92\u5f37\u5236\uff0c\u6240\u4ee5\u4e0d\u7528\u505aGMP\u300d<\/h3>\n<p><strong>\u6b63\u78ba\u8a8d\u77e5<\/strong>\uff1a<br \/>\n\u96d6\u7136FDA\u672a\u5f37\u5236GMP\uff0c\u4f46\u4f9d\u64da <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-700.11\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u00a7 700.11<\/a>{:target=&#8221;_blank&#8221;}\uff0c\u5316\u599d\u54c1\u4e0d\u5f97\u647b\u5047\u3002\u82e5\u7522\u54c1\u56e0\u88fd\u7a0b\u4e0d\u7576\u5c0e\u81f4\u6c61\u67d3\uff08\u5982\u5fae\u751f\u7269\u8d85\u6a19\uff09\uff0cFDA\u4ecd\u53ef\u8a8d\u5b9a\u70ba\u647b\u5047\u4e26\u6263\u7559\u9032\u53e3\u3002\u5efa\u7acbGMP\u662f\u8b49\u660e\u300c\u672a\u647b\u5047\u300d\u7684\u6700\u6709\u6548\u65b9\u5f0f\u3002<\/p>\n<h3>\u8aa4\u53402\uff1a\u300c\u6211\u5011\u6709ISO 9001\u5c31\u5920\u4e86\u300d<\/h3>\n<p><strong>\u6b63\u78ba\u8a8d\u77e5<\/strong>\uff1a<br \/>\nISO 9001\u662f\u901a\u7528\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\uff0c\u672a\u91dd\u5c0d\u5316\u599d\u54c1\u7279\u6027\uff08\u5982\u5fae\u751f\u7269\u63a7\u5236\u3001\u6210\u5206\u7a69\u5b9a\u6027\uff09\u3002FDA GMP\u6216ISO 22716\u624d\u5305\u542b\u5316\u599d\u54c1\u5c08\u5c6c\u8981\u6c42\uff0c\u5982\uff1a<\/p>\n<ul>\n<li>\u9632\u8150\u7cfb\u7d71\u9a57\u8b49\uff08Preservative Challenge Test\uff09<\/li>\n<li>\u8272\u6599\u6279\u6b21\u9593\u8272\u5dee\u7ba1\u7406<\/li>\n<li>\u9999\u7cbe\u904e\u654f\u539f\u6a19\u793a\u8ffd\u6eaf<\/li>\n<\/ul>\n<h3>\u8aa4\u53403\uff1a\u300c\u53ea\u8981\u6709\u6279\u6b21\u7d00\u9304\u5c31\u7b97\u7b26\u5408GMP\u300d<\/h3>\n<p><strong>\u6b63\u78ba\u8a8d\u77e5<\/strong>\uff1a<br \/>\n\u6279\u6b21\u7d00\u9304\u50c5\u662fGMP\u7684\u4e00\u90e8\u5206\u3002\u5b8c\u6574\u7684GMP\u9700\u6db5\u84cb\u4eba\u54e1\u8a13\u7df4\u3001\u8a2d\u5099\u7dad\u8b77\u3001\u74b0\u5883\u76e3\u6e2c\u3001\u504f\u5dee\u8655\u7406\u7b49\u7cfb\u7d71\u6027\u7ba1\u7406\u3002\u5efa\u8b70\u4f7f\u7528\u300cGMP\u81ea\u6211\u8a55\u4f30\u6aa2\u6838\u8868\u300d\uff0c\u78ba\u8a8d\u662f\u5426\u907a\u6f0f\u95dc\u9375\u9805\u76ee\u3002<\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<h2>2026\u5e74\u5f8cFDA\u5316\u599d\u54c1GMP\u7684\u767c\u5c55\u8da8\u52e2<\/h2>\n<h3>\u8da8\u52e21\uff1aMoCRA\u63a8\u52d5GMP\u9593\u63a5\u5f37\u5236\u5316<\/h3>\n<p>\u96d6\u7136MoCRA\u672a\u660e\u6587\u8981\u6c42GMP\uff0c\u4f46\u6cd5\u6848\u7b2c611\u689d\u8ce6\u4e88FDA\u300c\u8a2d\u65bd\u6aa2\u67e5\u6b0a\u300d\uff0cFDA\u53ef\u96a8\u6642\u7a3d\u6838\u5316\u599d\u54c1\u751f\u7522\u8a2d\u65bd\u3002\u5be6\u52d9\u4e0a\uff0cFDA\u6aa2\u67e5\u54e1\u6703\u53c3\u8003GMP\u6307\u5c0e\u610f\u898b\u8a55\u4f30\u5de5\u5ee0\u662f\u5426\u7b26\u5408\u300c\u672a\u647b\u5047\u300d\u6a19\u6e96\uff0c\u4f7fGMP\u6210\u70ba\u4e8b\u5be6\u4e0a\u7684\u5408\u898f\u8981\u6c42\u3002<\/p>\n<h3>\u8da8\u52e22\uff1a\u96fb\u5546\u5e73\u53f0\u63d0\u9ad8GMP\u9580\u6abb<\/h3>\n<p>Amazon\u3001Walmart\u7b49\u96fb\u5546\u5e73\u53f0\u9678\u7e8c\u8981\u6c42\u5316\u599d\u54c1\u8ce3\u5bb6\u63d0\u4f9b\uff1a<\/p>\n<ul>\n<li>\u7b2c\u4e09\u65b9GMP\u8a8d\u8b49\uff08\u5982ISO 22716\uff09<\/li>\n<li>\u7522\u54c1\u5b89\u5168\u6027\u6e2c\u8a66\u5831\u544a<\/li>\n<li>\u88fd\u9020\u5546\u8cac\u4efb\u4fdd\u96aa\u8b49\u660e<\/li>\n<\/ul>\n<p>\u672a\u4f86\u53f0\u7063\u5de5\u5ee0\u82e5\u8981\u9032\u5165\u7f8e\u570b\u96fb\u5546\u5e02\u5834\uff0cGMP\u8b49\u660e\u5c07\u6210\u70ba\u57fa\u672c\u5165\u5834\u5238\u3002<\/p>\n<h3>\u8da8\u52e23\uff1a\u6d88\u8cbb\u8005\u900f\u660e\u5ea6\u8981\u6c42\u63d0\u5347<\/h3>\n<p>\u7f8e\u570b\u6d88\u8cbb\u8005\u8d8a\u4f86\u8d8a\u95dc\u6ce8\u7522\u54c1\u4f86\u6e90\u8207\u88fd\u9020\u54c1\u8cea\uff0c\u54c1\u724c\u5546\u9700\u5728\u5b98\u7db2\u63ed\u9732\u4ee3\u5de5\u5ee0\u8cc7\u8a0a\u3002\u64c1\u6709GMP\u8a8d\u8b49\u7684\u53f0\u7063\u5de5\u5ee0\u5c07\u7372\u5f97\u66f4\u591a\u54c1\u724c\u5546\u9752\u775e\uff0c\u5f62\u6210\u5e02\u5834\u7af6\u722d\u512a\u52e2\u3002<\/p>\n<hr \/>\n<h2>\u7e3d\u7d50<\/h2>\n<ul>\n<li><strong>FDA\u5316\u599d\u54c1GMP\u70ba\u81ea\u9858\u9075\u5faa\u7684\u6307\u5c0e\u610f\u898b\uff0c\u975e\u5f37\u5236\u6cd5\u898f<\/strong>\uff0c\u4f46MoCRA\u6cd5\u6848\u8207\u5e02\u5834\u8da8\u52e2\u4f7f\u5176\u6210\u70ba\u5be6\u52d9\u5fc5\u8981<\/li>\n<li><strong>\u4e94\u5927\u7ba1\u7406\u8981\u7d20<\/strong>\u6db5\u84cb\u4eba\u54e1\u3001\u5ee0\u623f\u3001\u8a2d\u5099\u3001\u88fd\u7a0b\u3001\u5be6\u9a57\u5ba4\uff0c\u53f0\u7063\u5de5\u5ee0\u53ef\u53c3\u8003ISO 22716\u67b6\u69cb\u5efa\u7acb<\/li>\n<li><strong>\u8207\u6b50\u76dfISO 22716\u76f8\u6bd4<\/strong>\uff0cFDA GMP\u7121\u9700\u8a8d\u8b49\u4f46\u9700\u5b8c\u6574\u7d00\u9304\uff0c\u540c\u6642\u51fa\u53e3\u7f8e\u6b50\u5e02\u5834\u5efa\u8b70\u76f4\u63a5\u53d6\u5f97ISO 22716<\/li>\n<li><strong>\u5e38\u898b\u8aa4\u5340<\/strong>\u5305\u62ec\u8aa4\u4ee5\u70ba\u4e0d\u5f37\u5236\u5c31\u4e0d\u7528\u505a\u3001ISO 9001\u53ef\u66ff\u4ee3\u3001\u50c5\u9700\u6279\u6b21\u7d00\u9304\u5373\u53ef<\/li>\n<li><strong>2026\u5e74\u5f8c\u8da8\u52e2<\/strong>\u986f\u793aGMP\u5c07\u9593\u63a5\u5f37\u5236\u5316\uff0c\u96fb\u5546\u5e73\u53f0\u8207\u6d88\u8cbb\u8005\u900f\u660e\u5ea6\u8981\u6c42\u63d0\u9ad8\u9580\u6abb<\/li>\n<\/ul>\n<p>\u82e5\u5c0dFDA\u5316\u599d\u54c1GMP\u5be6\u65bd\u4ecd\u6709\u7591\u554f\uff0c\u6b61\u8fce\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/zh\/\" target=\"_blank\" rel=\"noopener\">\u7da0\u5708\u5708\u5b98\u7db2<\/a> \u7684\u5c08\u696d\u9867\u554f\u670d\u52d9\uff0c\u6216\u95b1\u8b80\u6211\u5011\u7684 <a href=\"https:\/\/greenoo.tw\/zh\/fda-cosmetic-compliance-registration-to-market\/\" target=\"_blank\" rel=\"noopener\">FDA\u5316\u599d\u54c1\u5408\u898f\u5730\u5716\uff1a\u5f9e\u8a3b\u518a\u5230\u4e0a\u5e02<\/a>\u3002<\/p>\n<hr \/>\n<h2>\u53c3\u8003\u8cc7\u6599<\/h2>\n<p>\u672c\u6587\u5167\u5bb9\u57fa\u65bc\u4ee5\u4e0bFDA\u5b98\u65b9\u8cc7\u6599\u64b0\u5beb\uff08\u622a\u81f32026\u5e741\u6708\uff09\uff1a<\/p>\n<ol>\n<li>U.S. Food and Drug Administration. &#8220;Draft Guidance for Industry: Good Manufacturing Practice (GMP)\/ISO 22716 Guidelines for Cosmetics.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-guidance-regulation\/draft-guidance-industry-good-manufacturing-practice-gmps-cosmetics\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/cosmetics\/cosmetics-guidance-regulation\/draft-guidance-industry-good-manufacturing-practice-gmps-cosmetics<\/a><\/li>\n<li>U.S. Food and Drug Administration. &#8220;Modernization of Cosmetics Regulation Act of 2022 (MoCRA).&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra<\/a><\/li>\n<li>Code of Federal Regulations Title 21, Part 700. &#8220;General Cosmetics.&#8221; <em>eCFR<\/em>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-G\/part-700\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-G\/part-700<\/a><\/li>\n<\/ol>\n<p><em>\u8a3b\uff1aFDA\u6cd5\u898f\u53ef\u80fd\u66f4\u65b0\uff0c\u5efa\u8b70\u67e5\u95b1\u6700\u65b0\u5b98\u65b9\u6587\u4ef6\u6216\u8aee\u8a62\u5c08\u696d\u9867\u554f\u3002<\/em><\/p>\n<hr \/>\n<p><strong>\u76f8\u95dc\u6587\u7ae0<\/strong>\uff1a<\/p>\n<ul>\n<li><a href=\"https:\/\/greenoo.tw\/zh\/mocra-fda-cosmetic-registration-guide\/\" target=\"_blank\" rel=\"noopener\">MoCRA\u6cd5\u898f\u4e0a\u8def\u5f8c\uff0cFDA\u5316\u599d\u54c1\u8a3b\u518a\u5236\u5ea6\u5b8c\u6574\u89e3\u6790\uff082026\u6700\u65b0\uff09<\/a><\/li>\n<li><a href=\"https:\/\/greenoo.tw\/zh\/taiwan-seller-fda-cosmetic-compliance-guide\/\" target=\"_blank\" rel=\"noopener\">\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u51fa\u53e3\u7f8e\u570bFDA\u5316\u599d\u54c1\u5408\u898f\u5168\u6307\u5357\uff082026\u6700\u65b0\uff09<\/a><\/li>\n<\/ul>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>FDA\u5316\u599d\u54c1GMP\u662f\u5f37\u5236\u8981\u6c42\u55ce\uff1f\u53f0\u7063\u5de5\u5ee0\u5fc5\u9808\u4e86\u89e3\u7684\u95dc\u9375\u5dee\u7570 \u4e0d\uff0cFDA\u5316\u599d\u54c1GMP\u76ee\u524d\u4e0d\u662f\u5f37\u5236\u6027\u6cd5\u898f\u8981\u6c42\uff0c\u800c\u662f [&hellip;]<\/p>","protected":false},"author":11,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[45],"tags":[],"class_list":["post-8263","post","type-post","status-publish","format-standard","hentry","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/8263"}],"collection":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/comments?post=8263"}],"version-history":[{"count":3,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/8263\/revisions"}],"predecessor-version":[{"id":19370,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/8263\/revisions\/19370"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=8263"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=8263"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=8263"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}