{"id":345,"date":"2017-03-21T16:05:39","date_gmt":"2017-03-21T16:05:39","guid":{"rendered":"http:\/\/hkinternational.biz\/?page_id=345"},"modified":"2017-05-13T13:07:34","modified_gmt":"2017-05-13T13:07:34","slug":"gmp-services","status":"publish","type":"page","link":"https:\/\/hkinternational.biz\/vi\/gmp-services\/","title":{"rendered":"GMP Services"},"content":{"rendered":"<p><\/p>\n<h4>Supplier Auditing<\/h4>\n<ul>\n<li>We perform both initial qualification audits to approve a new supplier and on-going audits to meet the requirements of your supplier management programme. In addition, investigative audits following process concerns are also undertaken.<\/li>\n<li>We perform API and finished products manufacturers\u2019 audit to check compliance with ICH,EU GMP,US FDA ,WHO GMP ETC.<\/li>\n<\/ul>\n<h4>PREPARING MANUFACTURING SITES FOR EU\/PICs\/US FDA, WHO GMP:<\/h4>\n<ul>\n<li>Normally we start a project by performing a GAP Analysis. This GAP Analysis will inform the clients about the current GMP situation of the facility concerned. The length of the audit depends on the complexity of the manufacturing site and the number of products. We perform a comprehensive analysis of the documents available at the manufacturing site before the audit will be performed, e.g. Site Master File, certain SOPs, Validation Plan, batch Record etc. As a result of the document analysis and the GAP inspection on site a comprehensive report will be developed which contains a to-do list and a GAP analysis Normally we continue the support after the audit by managing the project list. This means that our experts will manage the oversight over the project plan and monitors the milestones of the project.<\/li>\n<li>On request our experts prepare certain GMP documentation for the clients, e.g. SOPs, Validation Master Plan etc. We support clients by contacting the relevant competent regulatory authority in charge of the marketing authorization or of the manufacturing authorization.<\/li>\n<\/ul>\n<h4>COMPUTERIZED SYSTEM VALIDATION:<\/h4>\n<ul>\n<li>We provide complete validation suite for automated manufacturing practices used in pharmaceutical industries. Having exceptional Exposure to various processes and undertaken several automation, Software &amp; validation projects of the automated manufacturing systems makes us proficient to take care of validation requirements and US FDA21CFR Part 11 related issues. We use an efficient systematic, risk based, quality system approach to developing protocols. We also employ a very pragmatic approach to protocol execution, which allows us to fulfill all regulatory documentation requirements efficiently and with minimum of delay and with a minimum of interference with our customer&#8217;s operations. We have distinctive expertise in validation documentation and validation implementation. Following key services includes:\n<ul>\n<li>Laboratory Information Management System (LIMS) validation.<\/li>\n<li>Custom Database and spreadsheet development and validation.<\/li>\n<li>HPLC, GC, SAS, LCMS, Chromatography software validation including configuration and validation of network data systems.<\/li>\n<li>Preparation of validation master plans.<\/li>\n<li>Development of requirement specifications, documentation, traceability matrices and other GAMP documentation. ERP \/SAP validation.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h4>\u0110\u00e1nh gi\u00e1 v\u00e0 th\u1ea9m \u0111\u1ecbnh:<\/h4>\n<ul>\n<li>Ch\u00fang t\u00f4i s\u1ebd cung c\u1ea5p nh\u1eefng t\u00e0i li\u1ec7u sau:\n<ul>\n<li>K\u1ebf ho\u1ea1ch th\u1ea9m \u0111\u1ecbnh g\u1ed1c.<\/li>\n<li>K\u1ebf ho\u1ea1ch \u0111\u00e1nh gi\u00e1 nguy c\u01a1.<\/li>\n<li>C\u00e1c \u0111\u1ec1 c\u01b0\u01a1ng \u0111\u00e1nh gi\u00e1 v\u00e0 th\u1ea9m \u0111\u1ecbnh nh\u01b0 DQ, IQ, OQ v\u00e0 PQ.<\/li>\n<li>Th\u1ea9m \u0111\u1ecbnh h\u1ec7 th\u1ed1ng ti\u1ec7n \u00edch, th\u1ea9m \u0111\u1ecbnh qu\u00e1 tr\u00ecnh, th\u1ea9m \u0111\u1ecbnh v\u1ec7 sinh, th\u1ea9m \u0111\u1ecbnh h\u1ec7 th\u1ed1ng HVAC.<\/li>\n<li>Chu\u1ea9n b\u1ecb b\u00e1o c\u00e1o t\u00f3m l\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Supplier Auditing We perform both initial qualification audits to approve a new supplier and on-going audits to meet the requirements of your supplier management programme. In addition, investigative audits following process concerns are also undertaken. We perform API and finished<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"class_list":["post-345","page","type-page","status-publish","hentry"],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/P8vQwO-5z","_links":{"self":[{"href":"https:\/\/hkinternational.biz\/vi\/wp-json\/wp\/v2\/pages\/345","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hkinternational.biz\/vi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/hkinternational.biz\/vi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/hkinternational.biz\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hkinternational.biz\/vi\/wp-json\/wp\/v2\/comments?post=345"}],"version-history":[{"count":6,"href":"https:\/\/hkinternational.biz\/vi\/wp-json\/wp\/v2\/pages\/345\/revisions"}],"predecessor-version":[{"id":568,"href":"https:\/\/hkinternational.biz\/vi\/wp-json\/wp\/v2\/pages\/345\/revisions\/568"}],"wp:attachment":[{"href":"https:\/\/hkinternational.biz\/vi\/wp-json\/wp\/v2\/media?parent=345"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}