{"id":172,"date":"2024-04-19T16:41:25","date_gmt":"2024-04-19T07:41:25","guid":{"rendered":"https:\/\/cm-plus.co.jp\/id\/?page_id=172"},"modified":"2025-09-25T15:35:17","modified_gmt":"2025-09-25T06:35:17","slug":"contamination_control_strategy","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/id\/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\/id\/\">Beranda<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/\">Layanan<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/\">Konsultasi<\/a>\/<\/li>\n<li>Konsultasi Strategi Pengendalian Kontaminasi (CCS)<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Konsultasi<\/span><br class=\"wpTag\">Konsultasi Strategi Pengendalian <br \/> Kontaminasi (CCS)<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\/id\/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\/id\/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\/id\/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\">Apa itu \u201cStrategi Pengendalian Kontaminasi (CCS)\u201d yang Diperlukan oleh Lampiran 1 GMP UE yang Direvisi dan GMP PIC\/S?<\/h2>\n<p class=\"text01\">Pada tahun 2022, baik Lampiran 1 GMP UE (25 Agustus 2022) maupun Lampiran 1 GMP PIC\/S (9 September 2022) direvisi, yang mengakibatkan perubahan signifikan dari Lampiran 1 sebelumnya. Di antara poin-poin utama revisi tersebut, \u201cStrategi Pengendalian Kontaminasi (CCS)\u201d diwajibkan di berbagai bagian, sehingga perumusan CCS menjadi topik penting dalam Lampiran 1 yang direvisi.<\/p>\n<div class=\"comExtractBox\">\n<h3 class=\"headLine10\">Apa itu CCS? (Dari Glosarium Lampiran 1 PIC\/S GMP)<\/h3>\n<div class=\"subBox\">\n<h4 class=\"headLine12\">Lampiran 1 Glosarium<\/h4>\n<p class=\"title fBold\">PANDUAN PRAKTIK PEMBUATAN YANG BAIK UNTUK PRODUK OBAT LAMPIRAN (PE 009-17)<\/p>\n<p class=\"sml\">Lampiran 1 Glosarium<\/p>\n<p class=\"wpTag\"><span class=\"fBold\">Strategi Pengendalian Kontaminasi (CCS)\u00a0<\/span>\u2013 Serangkaian pengendalian yang direncanakan untuk mikroorganisme, endotoksin\/pirogen, dan partikel, yang berasal dari pemahaman produk dan proses terkini yang menjamin kinerja proses dan kualitas produk. Pengendalian dapat mencakup parameter dan atribut yang terkait dengan zat aktif, bahan dan komponen produk eksipien dan obat, kondisi pengoperasian fasilitas dan peralatan, pengendalian selama proses, spesifikasi produk akhir, serta metode dan frekuensi pemantauan dan pengendalian terkait.<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/picscheme.org\/docview\/6608\" target=\"_blank\" rel=\"noopener noreferrer\">LAMPIRAN PIC\/S GMP<\/a><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Elemen-elemen yang Perlu Dipertimbangkan dalam \u201cStrategi Pengendalian Kontaminasi (CCS)\u201d<\/h2>\n<p class=\"wpTag\">Pengembangan CCS memerlukan pengetahuan teknis dan proses yang terperinci. Sumber potensial kontaminasi meliputi kontaminasi mikroba, serpihan sel (seperti pirogen dan endotoksin), dan materi partikulat (seperti kaca, partikel lain yang tampak, dan partikel yang tidak tampak). Lampiran 1 yang direvisi mensyaratkan bahwa elemen yang harus dipertimbangkan dalam CCS mencakup setidaknya hal berikut (Lampiran 1 2.5):<\/p>\n<div class=\"awareness\">\n<ul class=\"comNumList\">\n<li><span class=\"num\">1.<\/span><span class=\"txt\">Desain pabrik dan proses (termasuk dokumentasi terkait)<\/span><\/li>\n<li><span class=\"num\">2.<\/span><span class=\"txt\">Fasilitas dan peralatan<\/span><\/li>\n<li><span class=\"num\">3.<\/span><span class=\"txt\">Personel<\/span><\/li>\n<li><span class=\"num\">4.<\/span><span class=\"txt\">Utilitas<\/span><\/li>\n<li><span class=\"num\">5.<\/span><span class=\"txt\">Manajemen bahan baku (termasuk kontrol dalam proses)<\/span><\/li>\n<li><span class=\"num\">6.<\/span><span class=\"txt\">Wadah dan penutup produk<\/span><\/li>\n<li><span class=\"num\">7.<\/span><span class=\"txt\">Persetujuan vendor (termasuk pemasok komponen utama, penyedia layanan sterilisasi untuk suku cadang dan sistem sekali pakai, dan penyedia layanan penting lainnya)<\/span><\/li>\n<li><span class=\"num\">8.<\/span><span class=\"txt\">Aktivitas yang dialihdayakan (seperti layanan sterilisasi kontrak) dan manajemen ketersediaan\/komunikasi informasi penting antara para pihak<\/span><\/li>\n<li><span class=\"num\">9.<\/span><span class=\"txt\">Penilaian risiko proses<\/span><\/li>\n<li><span class=\"num\">10.<\/span><span class=\"txt\">Validasi proses<\/span><\/li>\n<li><span class=\"num\">11.<\/span><span class=\"txt\">Validasi proses sterilisasi<\/span><\/li>\n<li><span class=\"num\">12.<\/span><span class=\"txt\">Pemeliharaan preventif (memelihara peralatan, utilitas, dan fasilitas dengan standar yang memastikan tidak ada risiko kontaminasi tambahan, baik yang direncanakan maupun tidak direncanakan)<\/span><\/li>\n<li><span class=\"num\">13.<\/span><span class=\"txt\">Pembersihan dan dekontaminasi (disinfeksi)<\/span><\/li>\n<li><span class=\"num\">14.<\/span><span class=\"txt\">Sistem pemantauan (termasuk penilaian kemungkinan memperkenalkan metode alternatif yang ilmiah untuk mendeteksi kontaminasi lingkungan)<\/span><\/li>\n<li><span class=\"num\">15.<\/span><span class=\"txt\">Mekanisme pencegahan (seperti analisis tren, investigasi terperinci, identifikasi akar penyebab, tindakan korektif dan pencegahan (CAPA), dan perlunya alat investigasi yang komprehensif)<\/span><\/li>\n<li><span class=\"num\">16.<\/span><span class=\"txt\">Peningkatan berkelanjutan berdasarkan informasi yang diperoleh dari hal di atas.<\/span><\/li>\n<\/ul>\n<\/div>\n<\/section>\n<section class=\"secBox comBorBox\">\n<h2 class=\"headLine05\">Layanan Konsultasi Strategi Pengendalian Kontaminasi (CCS) oleh CM Plus<\/h2>\n<p class=\"text01\">CM Plus menawarkan layanan dukungan berikut yang disesuaikan dengan kebutuhan pelanggan yang mempertimbangkan formulasi CCS.<\/p>\n<div class=\"comStepInner\">\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">LANGKAH 01. Memahami Poin-Poin Utama Perumusan CCS<\/span>Seminar tentang Revisi Lampiran 1\/Perumusan CCS<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">Kami merangkum perubahan dan poin-poin penting dalam LAMPIRAN 1 yang telah direvisi, dengan fokus pada poin-poin revisi. Kami memberikan panduan tentang penafsiran deskripsi terkait CCS dan menawarkan contoh struktur dokumen CCS untuk membantu memvisualisasikan pembuatan dokumen CCS yang sebenarnya.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/wp-content\/themes\/cmplus\/image\/common\/arrow05.webp\" alt=\"\"><\/div>\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">LANGKAH 02. Meninjau CCS Saat Ini<\/span>Analisis Kesenjangan CCS dan Usulan Metode Peninjauan untuk CCS Individual<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">Kami melakukan analisis kesenjangan dan meninjau langkah-langkah pengendalian kontaminasi saat ini, mengidentifikasi masalah dan mengusulkan dukungan perbaikan.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/wp-content\/themes\/cmplus\/image\/common\/arrow05.webp\" alt=\"\"><\/div>\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">LANGKAH 03. Menyiapkan Dokumen Konkret<\/span>Dukungan Persiapan Dokumen CCS<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">Kami menyediakan templat standar untuk dokumen CCS sesuai dengan Lampiran 1 yang direvisi dan, dikombinasikan dengan analisis pada Langkah 2, kami mendukung penyusunan dokumen yang disesuaikan dengan kebutuhan klien.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/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\/id\/wp-content\/themes\/cmplus\/image\/common\/icon_img07.webp\" alt=\"Feel Free to Contact CM Plus\"><\/div>\n<h3 class=\"headLine06\">Jangan Ragu untuk Menghubungi CM Plus<\/h3>\n<\/div>\n<p class=\"wpTag\">CM Plus memiliki konsultan dari berbagai bidang yang dapat menyesuaikan layanan untuk memenuhi kebutuhan Anda. Jangan ragu untuk menghubungi kami.<\/p>\n<div class=\"comApplyLink\"><a href=\"https:\/\/cm-plus.co.jp\/id\/contact_us\/\"><span class=\"sub\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/icon-mail.webp\" width=\"20\" alt=\"Click here to contact us.\">Klik di sini untuk menghubungi kami.<\/span><\/a><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Konten Terkait<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/portfolio\/project_details\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/div>\n<p><span class=\"subSpan\">Proyek<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/about_cm_plus\/record\/\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/div>\n<p><span class=\"subSpan\">Kinerja berdasarkan Angka<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section class=\"validation\">\n<h2 class=\"headLine04\">Informasi yang Berguna<\/h2>\n<p class=\"wpTag\">Silakan merujuk ke situs penyebaran informasi kami \u201cGMP Platform\u201d untuk artikel terkait.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\">\u201cStrategi Pengendalian Kontaminasi (CCS)\u201d yang Diperlukan oleh Lampiran 1 yang Direvisi<\/h4>\n<p class=\"wpTag\">Dari Artikel:<br class=\"wpTag\"><br \/>\n\u201c\u2018Lampiran 1 Panduan GMP Uni Eropa\u2019 (konten yang sama juga berlaku untuk Lampiran 1 PIC\/S) telah direvisi, yang mengharuskan perumusan strategi komprehensif untuk pengendalian kontaminasi yang disebut \u2018Strategi Pengendalian Kontaminasi (CCS).\u2019 \u2026.\u201d<br class=\"wpTag\"><br \/>\nPahami tujuan dari latar belakang revisinya.<br class=\"wpTag\"><br \/>\nTermasuk terjemahan pedoman perumusan Strategi Pengendalian Kontaminasi ECA: \u201cCara Mengembangkan dan Mendokumentasikan Strategi Pengendalian Kontaminasi.\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\"> Tentang Strategi Pengendalian Kontaminasi.<\/a><\/div>\n<\/div>\n<\/section>\n<section class=\"comOtherBox comOtherBox02\">\n<h2 class=\"headLine04\">Layanan Lainnya<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo01.webp\" alt=\"Engineering, Project Management\"><\/span><br \/>\n<span class=\"subSpan\">Keahlian Teknik, Manajemen Proyek<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/support_for_training\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo03.webp\" alt=\"Education\/Training Support\"><\/span><br \/>\n<span class=\"subSpan\">Dukungan Pendidikan\/Pelatihan<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/technology_information\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo04.webp\" alt=\"Technical Information Services\"><\/div>\n<p><span class=\"subSpan\">Layanan Informasi Teknis<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<\/article>\n<aside id=\"sideBar\">\n\t<p class=\"sideTtl\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/\"><span class=\"txtSpan barlow\">Layanan<\/span><\/a><\/p>\n\t<ul id=\"menu-service\" class=\"sideList\"><li id=\"menu-item-238\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-238\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/\">Keahlian Teknik, Manajemen Proyek<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-253\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-253\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/production_facility\/\">Layanan Satu Atap untuk Fasilitas Produksi<\/a><\/li>\n\t<li id=\"menu-item-240\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-240\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/construction_management\/\">Tentang Manajemen Konstruksi<\/a><\/li>\n\t<li id=\"menu-item-239\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-239\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/feature\/\">Manajemen Konstruksi oleh CM Plus<\/a><\/li>\n\t<li id=\"menu-item-243\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-243\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/project_flow\/\">Konstruksi Fasilitas<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-245\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-245\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/project_flow\/business_concept\/\">Business Concept<\/a><\/li>\n\t\t<li id=\"menu-item-246\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-246\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/project_flow\/conceptual_design\/\">Conceptual Design<\/a><\/li>\n\t\t<li id=\"menu-item-247\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-247\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/project_flow\/basic_design\/\">Basic Design<\/a><\/li>\n\t\t<li id=\"menu-item-248\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-248\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/project_flow\/purocurement\/\">Procurement<\/a><\/li>\n\t\t<li id=\"menu-item-249\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-249\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/project_flow\/detailed-design_construction\/\">Detailed Design \/ Production Management<\/a><\/li>\n\t\t<li id=\"menu-item-244\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-244\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/project_flow\/commissioning_qualification\/\">Trial Operation -Commissioning &#038; Qualification-<\/a><\/li>\n\t<\/ul>\n<\/li>\n\t<li id=\"menu-item-254\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-254\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/\">Sektor<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-242\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-242\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/pharma_medical-device\/\">Farmasi dan Alat Kesehatan<\/a>\n\t\t<ul class=\"sub-menu\">\n\t\t\t<li id=\"menu-item-263\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-263\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/pharma_medical-device\/sterile_medicine\/\">Sterile Pharmaceutical<\/a><\/li>\n\t\t\t<li id=\"menu-item-264\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-264\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/pharma_medical-device\/oral_agent\/\">Oral Drugs<\/a><\/li>\n\t\t\t<li id=\"menu-item-256\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-256\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/pharma_medical-device\/medium_molecule_drugs\/\">Medium-Molecule API<\/a><\/li>\n\t\t\t<li id=\"menu-item-257\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-257\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/pharma_medical-device\/macromolecular_drugs\/\">Large-Molecule (Biopharmaceutical) API<\/a><\/li>\n\t\t\t<li id=\"menu-item-813\" class=\"menu-item menu-item-type-custom menu-item-object-custom menu-item-813\"><a href=\"\/en\/service\/consulting\/regenerative_medicine\/\">Regenerative Medicine<\/a><\/li>\n\t\t<\/ul>\n<\/li>\n\t\t<li id=\"menu-item-265\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-265\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/food\/\">Makanan<\/a><\/li>\n\t\t<li id=\"menu-item-261\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-261\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/cosmetic\/\">Kosmetik<\/a><\/li>\n\t\t<li id=\"menu-item-260\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-260\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/home-care\/\">Produk Perawatan Rumah<\/a><\/li>\n\t\t<li id=\"menu-item-262\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-262\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/semiconductor\/\">Semikonduktor dan Perangkat Elektronik<\/a><\/li>\n\t\t<li id=\"menu-item-259\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-259\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/data_center\/\">Pusat Data<\/a><\/li>\n\t\t<li id=\"menu-item-258\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-258\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/chemical_plant\/\">Pabrik Kimia<\/a><\/li>\n\t\t<li id=\"menu-item-5871\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5871\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/logistics\/\">Logistik<\/a><\/li>\n\t\t<li id=\"menu-item-5870\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5870\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/field\/halal\/\">Halal<\/a><\/li>\n\t<\/ul>\n<\/li>\n\t<li id=\"menu-item-250\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-250\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/overseas_project_support\/\">Manajemen Proyek Lintas Batas<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-251\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-251\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/overseas_project_support\/partners\/\">Alliance Partners in Southeast Asia<\/a><\/li>\n\t\t<li id=\"menu-item-252\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-252\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/overseas_project_support\/partners_2\/\">Collaboration Partners in Europe and America<\/a><\/li>\n\t<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-266\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-266\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/\">Konsultasi<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-272\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-272\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/gmdp_consulting\/\">Konsultasi GMP &#038; GDP Farmasi<\/a><\/li>\n\t<li id=\"menu-item-271\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-271\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/qms_consulting\/\">QMS Alat Kesehatan<\/a><\/li>\n\t<li id=\"menu-item-274\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-274\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/regulatory_affairs\/\">Konsultasi Urusan Regulasi<\/a><\/li>\n\t<li id=\"menu-item-267\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-267\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/qualification_validation\/\">Konsultasi Validasi<\/a><\/li>\n\t<li id=\"menu-item-270\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-270\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/regenerative_medicine\/\">Konsultasi Pengobatan Regeneratif<\/a><\/li>\n\t<li id=\"menu-item-273\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-273\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/\">Konsultasi Strategi Pengendalian Kontaminasi (CCS)<\/a><\/li>\n\t<li id=\"menu-item-5658\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5658\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/data_integrity\/\">Konsultasi Integritas Data (DI)<\/a><\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-277\" class=\"jsLi noChild menu-item menu-item-type-post_type menu-item-object-page menu-item-277\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/support_for_training\/\">Dukungan Pendidikan\/ Pelatihan<\/a><\/li>\n<li id=\"menu-item-275\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-275\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/technology_information\/\">Layanan Informasi Teknis<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-1872\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1872\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/technology_information\/corressa\/\">CORRESSA<\/a><\/li>\n\t<li id=\"menu-item-5851\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5851\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/technology_information\/energy_management\/\">Solusi Manajemen Energi \u201cCMP Way\u201d<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul><\/aside><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Beranda\/ Layanan\/ Konsultasi\/ Konsultasi Strategi Pengendalian Kontaminasi (CCS) KonsultasiKonsultasi Strategi Pengendalian Kontaminasi (CCS) Apa itu \u201cStrategi Pengendalian Kontaminasi (CCS)\u201d yang Diperlukan oleh Lampiran 1 GMP UE yang Direvisi dan GMP PIC\/S? Pada tahun 2022, baik Lampiran 1 GMP UE (25 Agustus 2022) maupun Lampiran 1 GMP PIC\/S (9 September 2022) direvisi, yang mengakibatkan perubahan signifikan dari Lampiran 1 sebelumnya. Di antara poin-poin utama revisi tersebut, \u201cStrategi Pengendalian Kontaminasi (CCS)\u201d diwajibkan di berbagai bagian, sehingga perumusan CCS menjadi topik penting dalam Lampiran 1 yang direvisi. Apa itu CCS? (Dari Glosarium Lampiran 1 PIC\/S GMP) Lampiran 1 Glosarium PANDUAN PRAKTIK PEMBUATAN YANG BAIK UNTUK PRODUK OBAT LAMPIRAN (PE 009-17) Lampiran 1 Glosarium [&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],"class_list":["post-172","page","type-page","status-publish","hentry","keywords-gmpgdp"],"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\/id\/service\/consulting\/contamination_control_strategy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus\" \/>\n<meta property=\"og:description\" content=\"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/\" \/>\n<meta property=\"og:site_name\" content=\"CM Plus\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-25T06:35:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/ogp.png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"17 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/\",\"url\":\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/\",\"name\":\"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus\",\"isPartOf\":{\"@id\":\"https:\/\/cm-plus.co.jp\/id\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\",\"datePublished\":\"2024-04-19T07:41:25+00:00\",\"dateModified\":\"2025-09-25T06:35:17+00:00\",\"description\":\"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.\",\"breadcrumb\":{\"@id\":\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#primaryimage\",\"url\":\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\",\"contentUrl\":\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u30db\u30fc\u30e0\",\"item\":\"https:\/\/cm-plus.co.jp\/id\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Services\",\"item\":\"https:\/\/cm-plus.co.jp\/id\/service\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Consulting\",\"item\":\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Contamination Control Strategy (CCS) Consulting\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/cm-plus.co.jp\/id\/#website\",\"url\":\"https:\/\/cm-plus.co.jp\/id\/\",\"name\":\"CM Plus\",\"description\":\"Your Partner in Facility Construction, Quality Assurance, and Training Support\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/cm-plus.co.jp\/id\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus","description":"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/","og_locale":"en_US","og_type":"article","og_title":"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus","og_description":"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.","og_url":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/","og_site_name":"CM Plus","article_modified_time":"2025-09-25T06:35:17+00:00","og_image":[{"url":"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/ogp.png"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"17 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/","url":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/","name":"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus","isPartOf":{"@id":"https:\/\/cm-plus.co.jp\/id\/#website"},"primaryImageOfPage":{"@id":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#primaryimage"},"image":{"@id":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#primaryimage"},"thumbnailUrl":"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/key01.webp","datePublished":"2024-04-19T07:41:25+00:00","dateModified":"2025-09-25T06:35:17+00:00","description":"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.","breadcrumb":{"@id":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#primaryimage","url":"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/key01.webp","contentUrl":"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/key01.webp"},{"@type":"BreadcrumbList","@id":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/contamination_control_strategy\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u30db\u30fc\u30e0","item":"https:\/\/cm-plus.co.jp\/id\/"},{"@type":"ListItem","position":2,"name":"Services","item":"https:\/\/cm-plus.co.jp\/id\/service\/"},{"@type":"ListItem","position":3,"name":"Consulting","item":"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/"},{"@type":"ListItem","position":4,"name":"Contamination Control Strategy (CCS) Consulting"}]},{"@type":"WebSite","@id":"https:\/\/cm-plus.co.jp\/id\/#website","url":"https:\/\/cm-plus.co.jp\/id\/","name":"CM Plus","description":"Your Partner in Facility Construction, Quality Assurance, and Training Support","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/cm-plus.co.jp\/id\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/pages\/172","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/comments?post=172"}],"version-history":[{"count":14,"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/pages\/172\/revisions"}],"predecessor-version":[{"id":6085,"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/pages\/172\/revisions\/6085"}],"up":[{"embeddable":true,"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/pages\/155"}],"wp:attachment":[{"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/media?parent=172"}],"wp:term":[{"taxonomy":"keywords","embeddable":true,"href":"https:\/\/cm-plus.co.jp\/id\/wp-json\/wp\/v2\/keywords?post=172"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}