{"id":6079,"date":"2023-06-05T13:25:07","date_gmt":"2023-06-05T06:25:07","guid":{"rendered":"https:\/\/mark.co.id\/sites\/?page_id=6079"},"modified":"2023-07-02T21:03:47","modified_gmt":"2023-07-02T14:03:47","slug":"training-cgmp","status":"publish","type":"page","link":"https:\/\/mark.co.id\/sites\/academy\/training-cgmp\/","title":{"rendered":"Training cGMP"},"content":{"rendered":"

[vc_row][vc_column][vc_column_text]<\/p>\n

Praktik produksi yang baik (GMP = Good Manufacturing Practices) adalah praktik-praktik kerja yang diwajibkan agar sesuai dengan pedoman yang direkomendasikan oleh lembaga yang mengontrol otorisasi dan perizinan pembuatan dan penjualan makanan dan minuman, kosmetik, produk farmasi, suplemen makanan, dan peralatan medis. GMP memberikan persyaratan minimum yang harus dipenuhi oleh produsen untuk memastikan bahwa produk mereka secara konsisten berkualitas tinggi, dari batch ke batch, untuk tujuan penggunaan. Aturan yang mengatur setiap industri mungkin berbeda secara signifikan; namun, tujuan utama GMP untuk mencegah terjadinya kerugian pada pengguna akhir. Prinsip tambahan termasuk memastikan produk akhir bebas dari kontaminasi, konsisten dalam pembuatannya, telah didokumentasikan dengan baik, personelnya terlatih dengan baik, dan produk tersebut telah diperiksa kualitasnya lebih tidak hanya pada tahap akhir. GMP biasanya dipastikan melalui penggunaan yang efektif dari sistem manajemen mutu (QMS \u2013 ISO 9001).<\/p>\n

[\/vc_column_text][vc_text_separator 1=”style=““color:” 2=”#00529F;“>KELAS” 3=”INI” 4=”DITUJUKAN” 5=”KEPADA“” title=”MENGAPA SERTIFIKASI CGMP ?<\/b>” i_icon_fontawesome=”fa fa-user-circle-o” i_color=”custom” add_icon=”true” i_custom_color=”#00529f”][vc_column_text css=”.vc_custom_1685948897950{margin-top: -3% !important;margin-left: 5% !important;}”]<\/p>\n

GMP versi Organisasi Kesehatan Dunia (WHO = Organisasi Kesehatan Dunia) digunakan oleh regulator farmasi dan industri farmasi di lebih dari 100 negara di seluruh dunia, terutama di negara berkembang. GMP Uni Eropa (EU-GMP) memberlakukan persyaratan yang serupa dengan GMP WHO, seperti halnya versi FDA di AS. GMP serupa digunakan di negara lain seperti Australia, Kanada, Jepang, Arab Saudi, Singapura, Filipina, Vietnam, dan negara lain yang memiliki persyaratan GMP yang sangat maju\/canggih. Di Inggris Raya, Medicines Act (1968) mencakup sebagian besar aspek GMP dalam apa yang biasa disebut sebagai “The Orange Guide”, yang dinamai demikian karena warna; secara resmi dikenal sebagai Aturan dan Panduan untuk Produsen dan Distributor Farmasi. Sedangkan di Amerika Serikat FDA mewajibkan persyaratan GMP yang sangat spesifik yang berbeda dari yang ada di Uni-Eropa dan negara lain, obat yang disetujui atau disintesis tanpa sertifikasi FDA AS tidak dapat dijual secara legal di Amerika Serikat.<\/p>\n

Sejak publikasi GMP untuk Bahan Farmasi Aktif tahun 1999, oleh International Conference on Harmonization (ICH), GMP sekarang berlaku di negara-negara tersebut dan pengelompokan perdagangan yang merupakan penandatangan ICH (UE, Jepang, dan AS), dan berlaku di negara lain (misalnya , Australia, Kanada, Singapura) telah mengadopsi pedoman ICH untuk pembuatan dan pengujian bahan baku aktif.<\/p>\n

[\/vc_column_text][vc_text_separator 1=”style=““color:” 2=”#00529F;“>TUJUAN” 3=”PEMBELAJARAN“” title=”TUJUAN & SASARAN TRAINING CGMP?<\/b>” i_icon_fontawesome=”fa fa-heart” i_color=”custom” add_icon=”true” i_custom_color=”#00529f”][vc_row_inner css=”.vc_custom_1603262103784{margin-top: -3% !important;margin-left: 4% !important;}”][vc_column_inner width=”1\/2″][vc_cta h2=”” h4=”Memahami kaitan cGMP dengan standar keamanan pangan (BRCGS, ISO);” h4_font_container=”color:%23ffffff” h4_use_theme_fonts=”yes” txt_align=”center” style=”custom” use_custom_fonts_h4=”true” custom_background=”#00529f”][\/vc_cta][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_cta h2=”” h4=”Mampu mengembangkan prosedur dan rekaman serta mengimplementasikan persyaratan cGMP di Industri;” h4_font_container=”color:%23ffffff” h4_use_theme_fonts=”yes” txt_align=”center” style=”custom” use_custom_fonts_h4=”true” custom_background=”#00529f”][\/vc_cta][\/vc_column_inner][\/vc_row_inner][vc_row_inner css=”.vc_custom_1603262111762{margin-top: -3% !important;margin-left: 4% !important;}”][vc_column_inner][vc_cta h2=”” h4=”Mereview ketidaksesuaian yang sering ditemukan dalam audit\/ inspeksi terkait cGMP;” h4_font_container=”color:%23ffffff” h4_use_theme_fonts=”yes” txt_align=”center” style=”custom” use_custom_fonts_h4=”true” custom_background=”#00529f”][\/vc_cta][vc_cta h2=”” h4=”Sasaran: Mahasiswa\/ Dosen\/ Guru di bidang Farmasi\/ Kedokteran\/ Teknik\/ Lifescience, Karyawan, Supervisor, Apoteker, Manager, Marketing, CEO, Director.” h4_font_container=”color:%23ffffff” h4_use_theme_fonts=”yes” txt_align=”center” style=”custom” use_custom_fonts_h4=”true” custom_background=”#00529f”][\/vc_cta][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1600334440877{margin-top: 2% !important;}”][vc_column][vc_separator style=”dashed” border_width=”4″][vc_row_inner][vc_column_inner width=”1\/3″][vc_single_image image=”1960″ img_size=”full” alignment=”center” 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[vc_row][vc_column][vc_column_text] Praktik produksi yang baik (GMP = Good Manufacturing Practices) adalah praktik-praktik kerja yang diwajibkan agar sesuai dengan pedoman yang direkomendasikan oleh lembaga yang mengontrol otorisasi dan perizinan pembuatan dan penjualan makanan dan minuman, kosmetik, produk farmasi, suplemen makanan, dan peralatan medis. GMP memberikan persyaratan minimum yang harus dipenuhi oleh produsen untuk memastikan bahwa produk […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":3643,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"yoast_head":"\nTraining cGMP | Markcert<\/title>\n<meta name=\"description\" content=\"Praktik produksi yang baik (GMP = Good Manufacturing Practices) adalah praktik-praktik kerja yang diwajibkan agar sesuai dengan pedoman yang\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mark.co.id\/sites\/academy\/training-cgmp\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Training cGMP | Markcert\" \/>\n<meta property=\"og:description\" content=\"Praktik produksi yang baik (GMP = Good Manufacturing Practices) adalah praktik-praktik kerja yang diwajibkan agar sesuai dengan pedoman yang\" \/>\n<meta property=\"og:url\" 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