{"id":172,"date":"2024-04-19T16:41:25","date_gmt":"2024-04-19T07:41:25","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=172"},"modified":"2024-08-08T12:03:26","modified_gmt":"2024-08-08T03:03:26","slug":"contamination_control_strategy","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/contamination_control_strategy\/","title":{"rendered":"Contamination Control Strategy (CCS) Consulting"},"content":{"rendered":"<div id=\"contamination_control_strategy\">\n<div id=\"pagePath\">\n<ul>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/\">Home<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\">Services<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\">Consulting<\/a>\/<\/li>\n<li>Contamination Control Strategy (CCS) Consulting<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Consulting<\/span><br class=\"wpTag\">Contamination Control Strategy<br \/> (CCS) Consulting<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\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\" alt=\"Consulting Contamination Control Strategy (CCS) Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service09.webp\" alt=\"Consulting Contamination Control Strategy (CCS) Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service09.webp\" alt=\"Consulting Contamination Control Strategy (CCS) 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\">What is the \u201cContamination Control Strategy (CCS)\u201d Required by the Revised EU GMP and PIC\/S GMP Annex 1?<\/h2>\n<p class=\"text01\">In 2022, both EU GMP Annex 1 (August 25, 2022) and PIC\/S GMP Annex 1 (September 9, 2022) were revised, resulting in significant changes from the previous Annex 1. Among the key points of the revisions, the \u201cContamination Control Strategy (CCS)\u201d is required in various sections, making the formulation of CCS a critical topic in the revised Annex 1.<\/p>\n<div class=\"comExtractBox\">\n<h3 class=\"headLine10\">What is CCS? (From the PIC\/S GMP Annex 1 Glossary)<\/h3>\n<div class=\"subBox\">\n<h4 class=\"headLine12\">Annex1 Glossary<\/h4>\n<p class=\"title fBold\">GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES\u00a0(PE 009-17)<\/p>\n<p class=\"sml\">Annex1 Glossary<\/p>\n<p class=\"wpTag\"><span class=\"fBold\">Contamination Control Strategy (CCS)\u00a0<\/span>\u2013 A planned set of controls for microorganisms, endotoxin\/pyrogen and particles, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to active substance, excipient and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/picscheme.org\/docview\/6608\" target=\"_blank\" rel=\"noopener noreferrer\">PIC\/S GMP ANNEXES<\/a><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Elements to Consider in the \u201cContamination Control Strategy (CCS)\u201d<\/h2>\n<p class=\"wpTag\">The development of CCS requires detailed technical and process knowledge. Potential sources of contamination include microbial contamination, cell debris (such as pyrogens and endotoxins), and particulate matter (such as glass, other visible, and sub-visible particles). The revised Annex 1 requires that the elements to be considered in CCS include at least the following (Annex 1 2.5):<\/p>\n<div class=\"awareness\">\n<ul class=\"comNumList\">\n<li><span class=\"num\">1.<\/span><span class=\"txt\">Plant and process design (including related documentation)<\/span><\/li>\n<li><span class=\"num\">2.<\/span><span class=\"txt\">Facilities and equipment<\/span><\/li>\n<li><span class=\"num\">3.<\/span><span class=\"txt\">Personnel<\/span><\/li>\n<li><span class=\"num\">4.<\/span><span class=\"txt\">Utilities<\/span><\/li>\n<li><span class=\"num\">5.<\/span><span class=\"txt\">Raw material management (including in-process controls)<\/span><\/li>\n<li><span class=\"num\">6.<\/span><span class=\"txt\">Product containers and closures<\/span><\/li>\n<li><span class=\"num\">7.<\/span><span class=\"txt\">Vendor approval (including suppliers of key components, providers of sterilization -services for parts and single-use systems, and other critical service providers)<\/span><\/li>\n<li><span class=\"num\">8.<\/span><span class=\"txt\">Outsourced activities (such as contract sterilization services) and the management of the availability\/communication of critical information between parties<\/span><\/li>\n<li><span class=\"num\">9.<\/span><span class=\"txt\">Process risk assessment<\/span><\/li>\n<li><span class=\"num\">10.<\/span><span class=\"txt\">Process validation<\/span><\/li>\n<li><span class=\"num\">11.<\/span><span class=\"txt\">Validation of sterilization processes<\/span><\/li>\n<li><span class=\"num\">12.<\/span><span class=\"txt\">Preventive maintenance (maintaining equipment, utilities, and facilities to a -standard that ensures no additional contamination risk, both planned and unplanned)<\/span><\/li>\n<li><span class=\"num\">13.<\/span><span class=\"txt\">Cleaning and decontamination (disinfection)<\/span><\/li>\n<li><span class=\"num\">14.<\/span><span class=\"txt\">Monitoring systems (including the assessment of the possibility of introducing scientifically sound alternative methods for the detection of environmental contamination)<\/span><\/li>\n<li><span class=\"num\">15.<\/span><span class=\"txt\">Preventive mechanisms (such as trend analysis, detailed investigations, root cause identification, corrective and preventive actions (CAPA), and the need for comprehensive investigative tools)<\/span><\/li>\n<li><span class=\"num\">16.<\/span><span class=\"txt\">Continuous improvement based on information obtained from the above.<\/span><\/li>\n<\/ul>\n<\/div>\n<\/section>\n<section class=\"secBox comBorBox\">\n<h2 class=\"headLine05\">Contamination Control Strategy (CCS) Consulting Services by CM Plus<\/h2>\n<p class=\"text01\">CM Plus offers the following support services tailored to the needs of customers considering CCS formulation.<\/p>\n<div class=\"comStepInner\">\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">STEP 01. Understanding the Key Points of CCS Formulation<\/span>Seminar on the Revised Annex 1\/CCS Formulation<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">We summarize the changes and key points in the revised ANNEX 1, focusing on the points of the revisions. We provide guidance on interpreting CCS-related descriptions and offer examples of CCS document structures to help visualize the actual creation of CCS documents.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/contamination_control_strategy\/photo01.webp\" alt=\"STEP 01. Understanding the Key Points of CCS Formulation Seminar on the Revised Annex 1\/CCS Formulation\"><\/div>\n<\/div>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/arrow05.webp\" alt=\"\"><\/div>\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">STEP 02. Reviewing the Current CCS<\/span>CCS Gap Analysis and Proposal of Review Methods for Individual CCS<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">We conduct a gap analysis and review the current contamination control measures, identifying issues and proposing improvement support.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/contamination_control_strategy\/photo02.webp\" alt=\"STEP 02. Reviewing the Current CCS CCS Gap Analysis and Proposal of Review Methods for Individual CCS\"><\/div>\n<\/div>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/arrow05.webp\" alt=\"\"><\/div>\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">STEP 03. Preparing Concrete Documents<\/span>CCS Document Preparation Support<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">We provide standard templates for CCS documents in line with the revised Annex 1 and, combined with the analysis in Step 2, we support the preparation of documents tailored to the client\u2019s needs.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/contamination_control_strategy\/photo03.webp\" alt=\"STEP 03. Preparing Concrete Documents CCS Document Preparation Support\"><\/div>\n<\/div>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/arrow06.webp\" alt=\"\"><\/div>\n<div class=\"area pink\">\n<div class=\"ttlBox\">\n<div class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/icon_img07.webp\" alt=\"Feel Free to Contact CM Plus\"><\/div>\n<h3 class=\"headLine06\">Feel Free to Contact CM Plus<\/h3>\n<\/div>\n<p class=\"wpTag\">CM Plus has consultants from various fields who can customize services to meet your needs. Feel free to contact us.<\/p>\n<div class=\"comApplyLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/contact_us\/\"><span class=\"sub\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/icon-mail.webp\" width=\"20\" alt=\"Click here to contact us.\">Click here to contact us.<\/span><\/a><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Related Contents<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/project_details\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/div>\n<p><span class=\"subSpan\">Projects<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/about_cm_plus\/record\/\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/div>\n<p><span class=\"subSpan\">Performance by Numbers<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section class=\"validation\">\n<h2 class=\"headLine04\">Useful Information<\/h2>\n<p class=\"wpTag\">Please refer to our information dissemination site \u201cGMP Platform\u201d for related articles.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo13.webp\" alt=\"\u201cContamination Control Strategy (CCS)\u201d Required by the Revised Annex 1\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cContamination Control Strategy (CCS)\u201d Required by the Revised Annex 1<\/h4>\n<p class=\"wpTag\">From the article:<br class=\"wpTag\"><br \/>\n\u201cThe EU \u2018GMP Guidance Annex 1\u2019 (the same content also applies to PIC\/S Annex 1) has been revised, requiring the formulation of a comprehensive strategy for contamination control called \u2018Contamination Control Strategy (CCS).\u2019 \u2026.\u201d<br class=\"wpTag\"><br \/>\nUnderstand the purpose from the background of its revision.<br class=\"wpTag\"><br \/>\nIncluding a translation of the ECA\u2019s Contamination Control Strategy formulation guideline: \u201cHow to Develop and Document Contamination Control Strategy.\u201d<\/p>\n<\/div>\n<\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=17299\" target=\"_blank\" rel=\"noopener noreferrer\"> About Contamination Control Strategy.<\/a><\/div>\n<\/div>\n<\/section>\n<section class=\"comOtherBox comOtherBox02\">\n<h2 class=\"headLine04\">Other Services<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" 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In 2022, both EU GMP Annex 1 (August 25, 2022) and PIC\/S GMP Annex 1 (September 9, 2022) were revised, resulting in significant changes from the previous Annex 1. Among the key points of the revisions, the \u201cContamination Control Strategy (CCS)\u201d is required in various sections, making the formulation of CCS a critical topic in the revised Annex 1. What is CCS? (From the PIC\/S GMP Annex 1 Glossary) Annex1 Glossary GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":155,"menu_order":56,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[11],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Contamination Control Strategy(CCS) Consulting\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"Experienced consultants in contamination control strategies 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\/en\/service\/consulting\/contamination_control_strategy\/\" \/>\n<meta property=\"og:locale\" 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