{"id":166,"date":"2024-04-19T16:40:26","date_gmt":"2024-04-19T07:40:26","guid":{"rendered":"https:\/\/cm-plus.co.jp\/vn\/?page_id=166"},"modified":"2025-09-25T15:06:25","modified_gmt":"2025-09-25T06:06:25","slug":"qualification_validation","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/qualification_validation\/","title":{"rendered":"Validation Consulting"},"content":{"rendered":"<div id=\"qualification_validation\">\n<div id=\"pagePath\">\n<ul>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/\">Trang ch\u1ee7<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/\">D\u1ecbch v\u1ee5<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/\">T\u01b0 v\u1ea5n<\/a>\/<\/li>\n<li>T\u01b0 v\u1ea5n Th\u1ea9m \u0111\u1ecbnh<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">T\u01b0 v\u1ea5n<\/span><br class=\"wpTag\">T\u01b0 v\u1ea5n Th\u1ea9m \u0111\u1ecbnh<br \/>\n<span class=\"h1Photo\"><br \/>\n<span class=\"maskBox\"><br \/>\n<span class=\"topCover\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\" alt=\"Consulting Validation Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/image-service12.webp\" alt=\"Consulting Validation Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/image-service12.webp\" alt=\"Consulting Validation Consulting\"><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/h1>\n<\/div>\n<\/div>\n<div class=\"content\">\n<div class=\"mainBox\">\n<article id=\"conts\">\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Th\u1ea9m \u0111\u1ecbnh trong S\u1ea3n xu\u1ea5t D\u01b0\u1ee3c ph\u1ea9m<\/h2>\n<p class=\"text\">Th\u1ea9m \u0111\u1ecbnh \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a nh\u01b0 sau:<br class=\"wpTag\"><br \/>\n\u201cM\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh \u0111\u01b0\u1ee3c ghi ch\u00e9p v\u0103n b\u1ea3n cung c\u1ea5p \u0111\u1ea3m b\u1ea3o m\u1ee9c \u0111\u1ed9 cao r\u1eb1ng m\u1ed9t quy tr\u00ecnh, ph\u01b0\u01a1ng ph\u00e1p ho\u1eb7c h\u1ec7 th\u1ed1ng c\u1ee5 th\u1ec3 s\u1ebd t\u1ea1o ra k\u1ebft qu\u1ea3 \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc m\u1ed9t c\u00e1ch nh\u1ea5t qu\u00e1n. (ICH Q7A)\u201d<br class=\"wpTag\"><br \/>\n\u201cThi\u1ebft l\u1eadp b\u1eb1ng ch\u1ee9ng \u0111\u01b0\u1ee3c ghi ch\u00e9p cung c\u1ea5p \u0111\u1ea3m b\u1ea3o m\u1ee9c \u0111\u1ed9 cao r\u1eb1ng m\u1ed9t quy tr\u00ecnh c\u1ee5 th\u1ec3 s\u1ebd lu\u00f4n t\u1ea1o ra s\u1ea3n ph\u1ea9m \u0111\u00e1p \u1ee9ng c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt v\u00e0 thu\u1ed9c t\u00ednh ch\u1ea5t l\u01b0\u1ee3ng \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc m\u1ed9t c\u00e1ch nh\u1ea5t qu\u00e1n. (H\u01b0\u1edbng d\u1eabn Th\u1ea9m \u0111\u1ecbnh quy tr\u00ecnh c\u1ee7a FDA n\u0103m 1987)\u201d<\/p>\n<p class=\"text\">Th\u1ef1c hi\u1ec7n Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u qu\u1ea3 v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng cao l\u00e0 m\u1ed9t trong nh\u1eefng th\u00e1ch th\u1ee9c quan tr\u1ecdng nh\u1ea5t c\u1ea7n \u0111\u1ea1t \u0111\u01b0\u1ee3c trong c\u00e1c d\u1ef1 \u00e1n x\u00e2y d\u1ef1ng m\u1edbi ho\u1eb7c c\u1ea3i t\u1ea1o c\u00e1c nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m. G\u1ea7n \u0111\u00e2y, ng\u00e0nh c\u00f4ng nghi\u1ec7p d\u01b0\u1ee3c ph\u1ea9m \u0111\u00e3 chuy\u1ec3n \u0111\u1ed5i t\u1eeb Th\u1ea9m \u0111\u1ecbnh truy\u1ec1n th\u1ed1ng sang \u201cTh\u1ea9m \u0111\u1ecbnh d\u1ef1a tr\u00ean khoa h\u1ecdc v\u00e0 r\u1ee7i ro\u201d. Qu\u00e1 tr\u00ecnh chuy\u1ec3n \u0111\u1ed5i n\u00e0y \u0111\u00f2i h\u1ecfi ph\u1ea3i tri\u1ec3n khai \u0111\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 t\u1ea1o ra c\u00e1c k\u1ebf ho\u1ea1ch Th\u1ea9m \u0111\u1ecbnh d\u1ef1a tr\u00ean c\u00e1c \u0111\u00e1nh gi\u00e1 n\u00e0y, t\u0103ng c\u01b0\u1eddng n\u1ed7 l\u1ef1c c\u1ea7n thi\u1ebft cho qu\u00e1 tr\u00ecnh Th\u1ea9m \u0111\u1ecbnh.<\/p>\n<p>CM Plus cung c\u1ea5p c\u00e1c d\u1ecbch v\u1ee5 ph\u00f9 h\u1ee3p v\u1edbi nhu c\u1ea7u c\u1ee7a kh\u00e1ch h\u00e0ng, t\u1eeb h\u1ed7 tr\u1ee3 t\u1ea1o k\u1ebf ho\u1ea1ch Th\u1ea9m \u0111\u1ecbnh g\u1ed1c v\u00e0 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro, \u0111\u1ebfn chu\u1ea9n b\u1ecb v\u00e0 th\u1ef1c hi\u1ec7n c\u00e1c \u0111\u1ec1 c\u01b0\u01a1ng \u0111\u1ec3 \u0110\u00e1nh gi\u00e1 (DQ, IQ, OQ, PQ) ngay t\u1eeb giai \u0111o\u1ea1n l\u1eadp k\u1ebf ho\u1ea1ch. \u0110i\u1ec1u n\u00e0y gi\u00fap gi\u1ea3m b\u1edbt g\u00e1nh n\u1eb7ng cho kh\u00e1ch h\u00e0ng.<\/p>\n<p class=\"text\">Ngo\u00e0i ra, ch\u00fang t\u00f4i c\u00f3 th\u1ec3 \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u v\u1ec1 nhi\u1ec7m v\u1ee5 Th\u1ea9m \u0111\u1ecbnh ri\u00eang, t\u00e1ch bi\u1ec7t v\u1edbi c\u00e1c nhi\u1ec7m v\u1ee5 l\u1eadp k\u1ebf ho\u1ea1ch v\u00e0 thi\u1ebft k\u1ebf. Ch\u00fang t\u00f4i linh ho\u1ea1t trong vi\u1ec7c ph\u1ea3n h\u1ed3i cho nh\u1eefng kh\u00e1ch h\u00e0ng \u0111\u00e3 h\u1ee3p t\u00e1c v\u1edbi ch\u00fang t\u00f4i trong giai \u0111o\u1ea1n x\u00e2y d\u1ef1ng, v\u00ec v\u1eady h\u00e3y tho\u1ea3i m\u00e1i tham kh\u1ea3o \u00fd ki\u1ebfn \u200b\u200bc\u1ee7a ch\u00fang t\u00f4i.<\/p>\n<div class=\"comApplyBox\">\n<p class=\"ttl\">Vui l\u00f2ng li\u00ean h\u1ec7 v\u1edbi ch\u00fang t\u00f4i n\u1ebfu b\u1ea1n c\u1ea7n t\u01b0 v\u1ea5n v\u1ec1 v\u1ea5n \u0111\u1ec1 th\u1ea9m \u0111\u1ecbnh.<\/p>\n<div class=\"comApplyLink\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/contact_us\/\"><span class=\"sub\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon-mail.webp\" width=\"20\" alt=\"Contact Form\">LI\u00caN H\u1ec6<\/span><\/a><\/div>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Quy tr\u00ecnh Th\u1ea9m \u0111\u1ecbnh trong m\u1ed9t D\u1ef1 \u00e1n<\/h2>\n<div class=\"comStepInner\">\n<div class=\"area\">\n<div class=\"ttlBox\">\n<div class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img02.webp\" alt=\"Preparing the Validation Master Plan\"><\/div>\n<h3 class=\"headLine06\">Chu\u1ea9n b\u1ecb K\u1ebf ho\u1ea1ch Th\u1ea9m \u0111\u1ecbnh G\u1ed1c <\/h3>\n<\/div>\n<p class=\"wpTag\">K\u1ebf ho\u1ea1ch Th\u1ea9m \u0111\u1ecbnh g\u1ed1c (VMP) l\u00e0 m\u1ed9t k\u1ebf ho\u1ea1ch Th\u1ea9m \u0111\u1ecbnh  to\u00e0n di\u1ec7n \u0111\u01b0\u1ee3c bi\u00ean so\u1ea1n cho m\u1ed9t d\u1ef1 \u00e1n x\u00e2y d\u1ef1ng nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m. T\u00e0i li\u1ec7u n\u00e0y th\u01b0\u1eddng ghi l\u1ea1i c\u00e1c m\u1ee5c sau, \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh theo n\u1ed9i dung c\u1ee7a d\u1ef1 \u00e1n:<\/p>\n<div class=\"whiteBox\">\n<ul class=\"comRaiList\">\n<li>Ch\u00ednh s\u00e1ch Th\u1ea9m \u0111\u1ecbnh<\/li>\n<li>C\u1ea5u tr\u00fac t\u1ed5 ch\u1ee9c cho c\u00e1c ho\u1ea1t \u0111\u1ed9ng Th\u1ea9m \u0111\u1ecbnh<\/li>\n<li>C\u00e1c h\u1ec7 th\u1ed1ng ph\u1ea3i th\u1ef1c hi\u1ec7n Th\u1ea9m \u0111\u1ecbnh (c\u01a1 s\u1edf, thi\u1ebft b\u1ecb, m\u00e1y m\u00f3c, v.v.)<\/li>\n<li>T\u1ed5ng quan v\u1ec1 c\u00e1c quy tr\u00ecnh s\u1ea3n xu\u1ea5t<\/li>\n<li>\u0110\u1ecbnh d\u1ea1ng cho c\u00e1c \u0111\u1ec1 c\u01b0\u01a1ng v\u00e0 b\u00e1o c\u00e1o kh\u00e1c nhau<\/li>\n<li>L\u1ecbch tr\u00ecnh Th\u1ea9m \u0111\u1ecbnh<\/li>\n<li>Ki\u1ec3m so\u00e1t thay \u0111\u1ed5i v\u00e0 qu\u1ea3n l\u00fd sai l\u1ec7ch<\/li>\n<li>Tham chi\u1ebfu \u0111\u1ebfn c\u00e1c t\u00e0i li\u1ec7u, v.v.<\/li>\n<\/ul>\n<\/div>\n<p class=\"wpTag\">VMP \u0111\u01b0\u1ee3c t\u00f3m t\u1eaft trong giai \u0111o\u1ea1n l\u1eadp k\u1ebf ho\u1ea1ch c\u01a1 b\u1ea3n c\u1ee7a l\u1ecbch tr\u00ecnh t\u1ed5ng th\u1ec3 c\u1ee7a d\u1ef1 \u00e1n, l\u00e0m r\u00f5 ch\u00ednh s\u00e1ch th\u1ea9m \u0111\u1ecbnh cho d\u1ef1 \u00e1n.<\/p>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/arrow05.webp\" alt=\"\"><\/div>\n<div class=\"area\">\n<div class=\"ttlBox\">\n<div class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img01.webp\" alt=\"Conducting Risk Assessment\"><\/div>\n<h3 class=\"headLine06\">Ti\u1ebfn h\u00e0nh \u0110\u00e1nh gi\u00e1 R\u1ee7i ro<\/h3>\n<\/div>\n<p class=\"wpTag\">Trong nh\u1eefng n\u0103m g\u1ea7n \u0111\u00e2y, ph\u01b0\u01a1ng ph\u00e1p qu\u1ea3n l\u00fd r\u1ee7i ro ch\u1ea5t l\u01b0\u1ee3ng \u0111\u00e3 \u0111\u01b0\u1ee3c t\u00edch h\u1ee3p v\u00e0o quy tr\u00ecnh l\u1eadp k\u1ebf ho\u1ea1ch \u0111\u1ec3 th\u1ea9m \u0111\u1ecbnh. M\u1ed9t k\u1ebf ho\u1ea1ch Th\u1ea9m \u0111\u1ecbnh \u0111\u01b0\u1ee3c t\u1ea1o ra d\u1ef1a tr\u00ean k\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro. Trong giai \u0111o\u1ea1n \u0111\u00e1nh gi\u00e1 r\u1ee7i ro, ph\u1ea1m vi h\u1ec7 th\u1ed1ng ph\u1ea3i \u0111\u1ec3 \u0110\u00e1nh gi\u00e1 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh v\u00e0 n\u1ed9i dung c\u1ee7a c\u00e1c m\u1ee5c x\u00e1c minh s\u1ebd \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n trong DQ, IQ, OQ v\u00e0 PQ \u0111\u01b0\u1ee3c l\u1eadp k\u1ebf ho\u1ea1ch.<\/p>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/arrow05.webp\" alt=\"\"><\/div>\n<div class=\"area\">\n<div class=\"ttlBox\">\n<div class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img12.webp\" alt=\"Executing Qualification (DQ, IQ, OQ)\"><\/div>\n<h3 class=\"headLine06\">Th\u1ef1c hi\u1ec7n \u0110\u00e1nh gi\u00e1 (DQ, IQ, OQ)<\/h3>\n<\/div>\n<p class=\"wpTag\">D\u1ef1a tr\u00ean k\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro, c\u00e1c \u0111\u1ec1 c\u01b0\u01a1ng theo c\u00e1c k\u1ebf ho\u1ea1ch \u0110\u00e1nh gi\u00e1 kh\u00e1c nhau \u0111\u01b0\u1ee3c t\u1ea1o ra. Trong giai \u0111o\u1ea1n th\u1ef1c hi\u1ec7n \u0110\u00e1nh gi\u00e1, \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i ki\u1ec3m so\u00e1t thay \u0111\u1ed5i v\u00e0 sai l\u1ec7ch m\u1ed9t c\u00e1ch h\u1ee3p l\u00fd, \u0111\u1ea3m b\u1ea3o c\u00e1c \u0110\u00e1nh gi\u00e1 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo c\u00e1c t\u00e0i li\u1ec7u thi\u1ebft k\u1ebf v\u00e0 \u0111\u1ec1 c\u01b0\u01a1ng \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t. G\u1ea7n \u0111\u00e2y, vi\u1ec7c tham chi\u1ebfu k\u1ebft qu\u1ea3 c\u1ee7a c\u00e1c Ki\u1ec3m tra nghi\u1ec7m thu t\u1ea1i x\u01b0\u1edfng (FAT) ho\u1eb7c Ki\u1ec3m tra nghi\u1ec7m thu t\u1ea1i C\u00f4ng tr\u01b0\u1eddng (SAT) do c\u00e1c nh\u00e0 cung c\u1ea5p th\u1ef1c hi\u1ec7n trong IQ v\u00e0 OQ \u0111\u1ec3 ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 \u0111\u00e3 tr\u1edf th\u00e0nh th\u00f4ng l\u1ec7 ph\u1ed5 bi\u1ebfn.<\/p>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/arrow05.webp\" alt=\"\"><\/div>\n<div class=\"area\">\n<div class=\"ttlBox\">\n<div class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img13.webp\" alt=\"Executing PQ, Process Validation, Cleaning Validation, and Analytical Method Validation\"><\/div>\n<h3 class=\"headLine06\">Th\u1ef1c hi\u1ec7n PQ, Th\u1ea9m \u0111\u1ecbnh Quy tr\u00ecnh, Th\u1ea9m \u0111\u1ecbnh v\u1ec7 sinh v\u00e0 Th\u1ea9m \u0111\u1ecbnh ph\u01b0\u01a1ng ph\u00e1p ph\u00e2n t\u00edch<\/h3>\n<\/div>\n<p class=\"wpTag\">Sau khi ho\u00e0n th\u00e0nh IOQ, PQ v\u00e0 th\u1ea9m \u0111\u1ecbnh quy tr\u00ecnh (PV) cho c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t s\u1ebd \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh. PQ s\u1eed d\u1ee5ng nguy\u00ean li\u1ec7u ho\u1eb7c placebo \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong s\u1ea3n xu\u1ea5t th\u1ef1c t\u1ebf \u0111\u1ec3 x\u00e1c minh s\u1ea3n xu\u1ea5t trong \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh x\u1ea5u nh\u1ea5t, l\u1ea5y m\u1eabu c\u00e1c qu\u00e1 tr\u00ecnh quan tr\u1ecdng v\u00e0 trung gian \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o s\u1ea3n xu\u1ea5t kh\u1ea3 thi trong ph\u1ea1m vi v\u1eadn h\u00e0nh d\u1ef1 ki\u1ebfn. Do c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng nguy\u00ean li\u1ec7u \u0111\u1eaft ti\u1ec1n cho PQ v\u00e0 PV, n\u00ean \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i s\u1eed d\u1ee5ng d\u1eef li\u1ec7u OQ, xem x\u00e9t k\u1ef9 l\u01b0\u1ee1ng c\u00e1c m\u1ee5c th\u1ef1c hi\u1ec7n PQ v\u00e0 PV \u0111\u1ec3 t\u1ea1o ra c\u00e1c k\u1ebf ho\u1ea1chth\u1ea9m \u0111\u1ecbnh hi\u1ec7u qu\u1ea3 v\u00e0 th\u1ef1c hi\u1ec7n ch\u00fang m\u1ed9t c\u00e1ch h\u1ee3p l\u00fd. H\u01a1n n\u1eefa, \u0111\u1ed1i v\u1edbi th\u1ea9m \u0111\u1ecbnh quy tr\u00ecnh, th\u1ea9m \u0111\u1ecbnh ph\u01b0\u01a1ng ph\u00e1p v\u1ec7 sinh v\u00e0 ph\u01b0\u01a1ng ph\u00e1p ph\u00e2n t\u00edch \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 c\u0169ng l\u00e0 \u0111i\u1ec1u c\u1ea7n thi\u1ebft. S\u1ea3n xu\u1ea5t ch\u1ec9 c\u00f3 th\u1ec3 b\u1eaft \u0111\u1ea7u khi t\u1ea5t c\u1ea3 c\u00e1c quy tr\u00ecnh th\u1ea9m \u0111\u1ecbnh n\u00e0y ho\u00e0n t\u1ea5t.<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">T\u1ea1i CM Plus\u2026<\/h2>\n<h3 class=\"headLine06\">X\u00e1c \u0111\u1ecbnh ph\u1ea1m vi \u0111\u00e1nh gi\u00e1  s\u1eed d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p ti\u1ebfp c\u1eadn d\u1ef1a tr\u00ean r\u1ee7i ro<\/h3>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qualification_validation\/img01.webp\" alt=\"Determining Qualification Scope Using Risk-Based Approach\"><\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">\u1ede giai \u0111o\u1ea1n l\u1eadp k\u1ebf ho\u1ea1ch th\u1ea9m \u0111\u1ecbnh, tr\u01b0\u1edbc ti\u00ean c\u1ea7n ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 r\u1ee7i ro \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 xem c\u00e1c c\u01a1 s\u1edf v\u00e0 thi\u1ebft b\u1ecb (h\u1ec7 th\u1ed1ng) \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o c\u00f3 t\u00e1c \u0111\u1ed9ng tr\u1ef1c ti\u1ebfp \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m v\u00e0 s\u1ef1 an to\u00e0n c\u1ee7a b\u1ec7nh nh\u00e2n hay kh\u00f4ng. D\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 n\u00e0y, ph\u1ea1m vi c\u1ee7a c\u00e1c h\u1ec7 th\u1ed1ng \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh (\u0111\u00e1nh gi\u00e1 h\u1ec7 th\u1ed1ng). Vi\u1ec7c ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 h\u1ec7 th\u1ed1ng ch\u00ednh x\u00e1c cho ph\u00e9p \u0111\u00e1nh gi\u00e1 h\u1ee3p l\u00fd, d\u1eabn \u0111\u1ebfn c\u1ea3i thi\u1ec7n ch\u1ea5t l\u01b0\u1ee3ng c\u00f4ng vi\u1ec7c th\u1ea9m \u0111\u1ecbnh v\u00e0 gi\u1ea3m chi ph\u00ed kh\u00f4ng c\u1ea7n thi\u1ebft.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">So\u1ea1n th\u1ea3o K\u1ebf ho\u1ea1ch \u0110\u00e1nh gi\u00e1 D\u1ef1a tr\u00ean URS<\/h3>\n<p class=\"text\">Ph\u1ee5 l\u1ee5c 15 c\u1ee7a PIC\/S GMP quy \u0111\u1ecbnh r\u1eb1ng th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt y\u00eau c\u1ea7u c\u1ee7a ng\u01b0\u1eddi d\u00f9ng (URS) ph\u1ea3i \u0111\u01b0\u1ee3c tham chi\u1ebfu trong su\u1ed1t v\u00f2ng \u0111\u1eddi th\u1ea9m \u0111\u1ecbnh. Do \u0111\u00f3, URS c\u1ea7n \u0111\u01b0\u1ee3c tham chi\u1ebfu t\u1eeb c\u00e1c giai \u0111o\u1ea1n ban \u0111\u1ea7u c\u1ee7a \u0111\u00e1nh gi\u00e1 . T\u1ea1i CM Plus, ch\u00fang t\u00f4i \u0111\u1ec1 xu\u1ea5t so\u1ea1n th\u1ea3o k\u1ebf ho\u1ea1ch \u0111\u00e1nh gi\u00e1 d\u1ef1 th\u1ea3o b\u1eaft \u0111\u1ea7u b\u1eb1ng URS. C\u00e1ch ti\u1ebfp c\u1eadn n\u00e0y \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c y\u00eau c\u1ea7u \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh trong URS \u0111\u01b0\u1ee3c li\u00ean k\u1ebft tr\u1ef1c ti\u1ebfp v\u1edbi c\u00e1c m\u1ee5c x\u00e1c minh, l\u00e0m r\u00f5 m\u1ed1i quan h\u1ec7 gi\u1eefa c\u00e1c y\u00eau c\u1ea7u v\u00e0 \u0111\u00e1nh gi\u00e1 v\u00e0 cho ph\u00e9p t\u1ea1o ra c\u00e1c k\u1ebf ho\u1ea1ch \u0111\u00e1nh gi\u00e1 ph\u00f9 h\u1ee3p. H\u01a1n n\u1eefa, ngay c\u1ea3 trong c\u00e1c ho\u1ea1t \u0111\u1ed9ng sau khi tri\u1ec3n khai, vi\u1ec7c tham chi\u1ebfu URS c\u0169ng t\u1ea1o \u0111i\u1ec1u ki\u1ec7n thu\u1eadn l\u1ee3i cho vi\u1ec7c qu\u1ea3n l\u00fd thay \u0111\u1ed5i ph\u00f9 h\u1ee3p.<\/p>\n<div class=\"bigPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qualification_validation\/img02.webp\" alt=\"Drafting Qualification Plans Based on URS\"><br \/>\n<span class=\"photoIco\"><br \/>\n<a href=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qualification_validation\/img02.webp\" class=\"popImg\">&nbsp;<\/a><br \/>\n<\/span>\n<\/div>\n<h3 class=\"headLine06\">Th\u1ea9m \u0111\u1ecbnh H\u1ec7 th\u1ed1ng M\u00e1y t\u00ednh \/Ph\u1ea7n m\u1ec1m <\/h3>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qualification_validation\/photo01.webp\" alt=\"Validation for Computer Systems\/Software\"><\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">Ch\u00fang t\u00f4i c\u0169ng cung c\u1ea5p h\u1ed7 tr\u1ee3 \u0111\u1ec3 tri\u1ec3n khai th\u1ea9m \u0111\u1ecbnh h\u1ec7 th\u1ed1ng m\u00e1y t\u00ednh (CSV) v\u00e0 \u0111\u1ea3m b\u1ea3o ph\u1ea7n m\u1ec1m m\u00e1y t\u00ednh (CSA) cho vi\u1ec7c gi\u1edbi thi\u1ec7u c\u00e1c h\u1ec7 th\u1ed1ng CNTT nh\u01b0 H\u1ec7 th\u1ed1ng Th\u1ef1c hi\u1ec7n S\u1ea3n xu\u1ea5t (MES) v\u00e0 H\u1ec7 th\u1ed1ng Qu\u1ea3n l\u00fd Th\u00f4ng tin Ph\u00f2ng th\u00ed nghi\u1ec7m (LIMS). Ph\u01b0\u01a1ng ph\u00e1p c\u1ee7a ch\u00fang t\u00f4i tu\u00e2n th\u1ee7 ISPE GAMP5 (Phi\u00ean b\u1ea3n th\u1ee9 2) v\u00e0 h\u01b0\u1edbng d\u1eabn d\u1ef1 th\u1ea3o CSA c\u1ee7a FDA, cung c\u1ea5p c\u00e1c \u0111\u1ec1 xu\u1ea5t v\u1ec1 ho\u1ea1t \u0111\u1ed9ng th\u1eed nghi\u1ec7m v\u00e0 t\u1ea1o k\u1ebf ho\u1ea1ch d\u1ef1a tr\u00ean r\u1ee7i ro. Ch\u00fang t\u00f4i c\u0169ng cung c\u1ea5p t\u01b0 v\u1ea5n v\u1ec1 c\u00e1c y\u00eau c\u1ea7u v\u1ec1 t\u00ednh to\u00e0n v\u1eb9n c\u1ee7a d\u1eef li\u1ec7u (b\u1ea3o m\u1eadt, theo d\u00f5i truy v\u1ebft, l\u01b0u tr\u1eef d\u1eef li\u1ec7u, v.v.) c\u1ea7n thi\u1ebft cho c\u00e1c h\u1ec7 th\u1ed1ng m\u00e1y t\u00ednh.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Qu\u1ea3n l\u00fd H\u1ed3 s\u01a1 d\u1ef1a tr\u00ean Th\u1ef1c h\u00e0nh H\u1ed3 s\u01a1 t\u1ed1t (GDP)<\/h3>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qualification_validation\/photo02.webp\" alt=\"Document Management Based on Good Document Practice (GDP)\"><\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">Vi\u1ec7c Th\u1ea9m \u0111\u1ecbnh th\u00e0nh c\u00f4ng kh\u00f4ng th\u1ec3 di\u1ec5n ra n\u1ebfu kh\u00f4ng c\u00f3 qu\u1ea3n l\u00fd t\u00e0i li\u1ec7u th\u00e0nh c\u00f4ng trong m\u1ed9t d\u1ef1 \u00e1n. T\u1ea1i CM Plus, ch\u00fang t\u00f4i cung c\u1ea5p h\u01b0\u1edbng d\u1eabn v\u00e0 h\u1ed7 tr\u1ee3 d\u1ef1a tr\u00ean Th\u1ef1c h\u00e0nh t\u00e0i li\u1ec7u t\u1ed1t (GDP), bao g\u1ed3m qu\u1ea3n l\u00fd t\u00e0i li\u1ec7u c\u1ee7a nh\u00e0 cung c\u1ea5p v\u00e0 ch\u00ednh th\u1ee9c h\u00f3a c\u00e1c quy t\u1eafc t\u1ea1o h\u1ed3 s\u01a1, \u0111\u1ec3 h\u1ed7 tr\u1ee3 vi\u1ec7c t\u1ea1o t\u00e0i li\u1ec7u tu\u00e2n th\u1ee7 GMP. Ngo\u00e0i ra, ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 vi\u1ec7c t\u1ea1o t\u00e0i li\u1ec7u hu\u1ea5n luy\u1ec7n GMP, \u0111\u1ec1 c\u01b0\u01a1ng PQ\/PV v\u00e0 SOP d\u1ef1a tr\u00ean nhu c\u1ea7u c\u1ee7a kh\u00e1ch h\u00e0ng.<\/p>\n<\/div>\n<\/div>\n<ul class=\"comInfoList\">\n<li>\n<p class=\"wpTag\">\u0110\u1ec3 th\u1ea9m \u0111\u1ecbnh nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t v\u00e0 thi\u1ebft b\u1ecb ki\u1ebfn \u200b\u200btr\u00fac,<br class=\"wpTag\">pvui l\u00f2ng tham kh\u1ea3o m\u1ee5c V\u1eadn h\u00e0nh &#038; \u0110\u00e1nh gi\u00e1 (C&#038;Q) trong d\u1ecbch v\u1ee5 k\u1ef9 thu\u1eadt.<\/p>\n<div class=\"comLink\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/project_flow\/commissioning_qualification\/\"><span class=\"subSpan\">Quy tr\u00ecnh \u0110\u00e1nh gi\u00e1 v\u00e0 Th\u1ea9m \u0111\u1ecbnh<\/span><\/a><\/div>\n<\/li>\n<\/ul>\n<\/section>\n<hr class=\"lineHr\">\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">N\u1ed9i dung li\u00ean quan<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/portfolio\/project_details\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/div>\n<p><span class=\"subSpan\">D\u1ef1 \u00e1n<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/about_cm_plus\/record\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/div>\n<p><span class=\"subSpan\">Th\u00e0nh t\u1ef1u qua c\u00e1c con s\u1ed1<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section class=\"validation\">\n<h2 class=\"headLine04\">Th\u00f4ng tin h\u1eefu \u00edch<\/h2>\n<p class=\"wpTag\">Vui l\u00f2ng tham kh\u1ea3o c\u00e1c b\u00e0i vi\u1ebft tr\u00ean trang web ph\u1ed5 bi\u1ebfn th\u00f4ng tin c\u1ee7a ch\u00fang t\u00f4i \u201cGMP platform\u201d.\t<br class=\"wpTag\"><br \/>\nM\u1eb7c d\u00f9 ti\u00eau \u0111\u1ec1 bao g\u1ed3m \u201cX\u00e2y d\u1ef1ng nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m\u201d, nh\u01b0ng n\u1ed9i dung \u00e1p d\u1ee5ng cho vi\u1ec7c x\u00e2y d\u1ef1ng trong nhi\u1ec1u ng\u00e0nh c\u00f4ng nghi\u1ec7p kh\u00e1c nhau, kh\u00f4ng gi\u1edbi h\u1ea1n \u1edf c\u00e1c nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo07.webp\" alt=\"\u201cHow to Build a Pharmaceutical Plant\u201d\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cB\u00ed quy\u1ebft x\u00e2y d\u1ef1ng nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m\u201d<\/h4>\n<p class=\"wpTag\">Ki\u1ebfn th\u1ee9c chuy\u00ean m\u00f4n \u0111\u1ec3 ho\u00e0n th\u00e0nh th\u00e0nh c\u00f4ng c\u00e1c d\u1ef1 \u00e1n x\u00e2y d\u1ef1ng nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m \u0111\u01b0\u1ee3c bi\u00ean so\u1ea1n. N\u00f3 bao g\u1ed3m c\u00e1c ho\u1ea1t \u0111\u1ed9ng C&#038;Q\/Th\u1ea9m \u0111\u1ecbnh c\u1ea7n \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u1edf t\u1eebng giai \u0111o\u1ea1n c\u1ee7a d\u1ef1 \u00e1n. N\u00f3 gi\u1ea3i th\u00edch m\u1ecdi th\u1ee9 t\u1eeb vi\u1ec7c x\u00e2y d\u1ef1ng chi\u1ebfn l\u01b0\u1ee3c C&#038;Q \u0111\u1ebfn DR\/DQ, SAT v\u00e0 IQ\/OQ.<\/p>\n<\/div>\n<\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=7025\" target=\"_blank\" rel=\"noopener noreferrer\">M\u1ee5c l\u1ee5c Ki\u1ebfn th\u1ee9c chuy\u00ean m\u00f4n v\u1ec1 X\u00e2y d\u1ef1ng Nh\u00e0 m\u00e1y D\u01b0\u1ee3c ph\u1ea9m<\/a><\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=1786\" target=\"_blank\" rel=\"noopener noreferrer\">X\u00e2y d\u1ef1ng Chi\u1ebfn l\u01b0\u1ee3c cho C&#038;Q<\/a><\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=8895\" target=\"_blank\" rel=\"noopener noreferrer\">Xem x\u00e9t thi\u1ebft k\u1ebf (DR) v\u00e0 \u0110\u00e1nh gi\u00e1 thi\u1ebft k\u1ebf (DQ)<\/a><\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=8937\" target=\"_blank\" rel=\"noopener noreferrer\">SAT, Danh m\u1ee5c c\u00e1c c\u00f4ng vi\u1ec7c c\u1ea7n ho\u00e0n t\u1ea5t., IQ\/OQ<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Ti\u1ebfng Nh\u1eadt)<\/span><\/div>\n<p class=\"wpTag text\">Ch\u00fang t\u00f4i \u0111\u00e3 xu\u1ea5t b\u1ea3n m\u1ed9t cu\u1ed1n s\u00e1ch phi\u00ean b\u1ea3n ti\u1ebfng Anh. Vui l\u00f2ng tham kh\u1ea3o tin t\u1ee9c n\u00e0y.<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/en\/news\/event\/2023_0609\/\" rel=\"noopener noreferrer\"> B\u00e0i thuy\u1ebft tr\u00ecnh t\u1ea1i H\u1ed9i ngh\u1ecb th\u01b0\u1eddng ni\u00ean n\u0103m 2023 c\u1ee7a ISPE Indonesia<\/a><\/div>\n<\/div>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo09.webp\" alt=\"\u201cQu\u1ea3n l\u00fd d\u1ef1 \u00e1n c\u1ee7a ch\u1ee7 \u0111\u1ea7u t\u01b0 trong x\u00e2y d\u1ef1ng nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m, \u1ea5n b\u1ea3n l\u1ea7n th\u1ee9 2\u201d\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cQu\u1ea3n l\u00fd d\u1ef1 \u00e1n c\u1ee7a ch\u1ee7 \u0111\u1ea7u t\u01b0 trong x\u00e2y d\u1ef1ng nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m, \u1ea5n b\u1ea3n l\u1ea7n th\u1ee9 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[&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":155,"menu_order":54,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[10,11],"class_list":["post-166","page","type-page","status-publish","hentry","keywords-validation","keywords-gmpgdp"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Validation Consulting\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"Experienced consultants in validation provide support with services tailored to your specific challenges.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/qualification_validation\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" 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