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programı ilaç, kozmetik, medikal cihazlar, gıda, tarım, kimya ve laboratuvar sektörlerinde aktif olarak kullanılmaktadır."]},"beginTime":397,"endTime":497,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=397&ask_summarization=1"},{"index":3,"title":"GMP'nin Tarihsel Gelişimi","list":{"type":"unordered","items":["1905 yılında difteri aşısının kontaminasyonu kaynaklı 20 ölümle birlikte Dünya Sağlık Örgütü ve sağlık platformları harekete geçmeye başlamıştır.","1906 yılında Chicago'da et paketleme endüstrisinin kötü şartları nedeniyle zehirlenmelere sebebiyet verilmesi, Amerika Birleşik Devletleri'nin Gıda ve İlaç Dairesi'nin kurulmasına vesile olmuştur.","1937 yılında sülfni limit öksürük şurubundan kaynaklı 107 ölüm, 1955 yılında çocuk felci aşısındaki aktif virüs nedeniyle 250 çocuk felci vakası yaşanmıştır."]},"beginTime":497,"endTime":585,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=497&ask_summarization=1"},{"index":4,"title":"Önemli Vakalar ve GMP'nin Doğuşu","list":{"type":"unordered","items":["1959 yılında tüm dünyada etkisini gösteren ve tarihe \"Contergam faciası\" olarak geçen olayda, gebelerde mide bulantısını bertaraf etmek için kullanılan talidomid etken maddesi plasentadan fetusa geçerek kolsuz, bacaksız veya küçük kol küçük bacak şeklinde anormallerle dünyaya gelen birçok çocuk meydana gelmiştir.","1958 yılında Birleşmiş Milletler Gıda ve Tarım Örgütü \"İyi İmalat ve Kontrolü Milletlerarası Kararı\" çıkarmıştır."]},"beginTime":585,"endTime":788,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=585&ask_summarization=1"},{"index":5,"title":"GMP'nin Tarihsel Gelişimi","list":{"type":"unordered","items":["1960 yılında Amerika Birleşik Devletleri'nin Gıda ve İlaç Dairesi, milletlerarası kararın gıda ürünleri için kullanılmasını uygun görüyor ve öneriyor.","1968 yılında Dünya Sağlık Örgütü, Contergan faciasından sonra iyi ilaç imalat ve kalite kontrol uygulamaları önerisi getiriyor.","1970'li yıllarda ilk olarak Avrupa Birliği'nde ve Amerika Birleşik Devletleri'nde uygulamalar başlanıyor, 1992 yılında 12 Avrupa Birliği ülkesi tarafından ortak bir rehber yayınlanıyor ve 1993 yılında GMP iyi üretim uygulamaları kanunlaşıyor."]},"beginTime":800,"endTime":869,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=800&ask_summarization=1"},{"index":6,"title":"Türkiye'de GMP'nin Gelişimi","list":{"type":"unordered","items":["Türkiye'de 1928'lerden bu yana ilaç endüstrisinde devlet kontrolü var, İspanya ve Tıbbi Müstazarlar Kanunu devlet kontrolünde ilaç üretilmesini konu alan bir kanun.","1984 yılında Beşeri Tıbbi Ürünler İmalathaneleri Yönetmeliği Kalite Kontrol Esasları çıkıyor.","1994 yılında Beşeri Tıbbi Ürünler İmalathaneleri Yönetmeliği bir uygulama kılavuzu çıkartıyor ve 2004 yılında son şekliyle yayınlanıyor."]},"beginTime":869,"endTime":925,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=869&ask_summarization=1"},{"index":7,"title":"Türkiye'de GMP'nin Gelişimi (Devam)","list":{"type":"unordered","items":["2011 yılında Tarım ve Orman Bakanlığı Veteriner Tıbbi Ürünler Hakkında Yönetmelik çıkartıyor ve bir GMP kılavuzu yayınlıyorlar.","2013 yılında ISO 22716 kozmetik ürünler için iyi imalat uygulamaları kılavuzu yürürlüğe giriyor.","Türkiye'de yaygın olan Avrupa Birliği'nin GMP kılavuzudur ve bu kılavuz diğer ülkelerin kılavuzlarını rehber göstererek oluşturulmuştur."]},"beginTime":925,"endTime":1075,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=925&ask_summarization=1"},{"index":8,"title":"GMP'nin Diğer Sektörlerdeki Uygulamaları","list":{"type":"unordered","items":["GMP kılavuzları Avrupa Birliği GMP kılavuzundan alınmış olup, farklı sektörlerde bağımsız kuruluşlar tarafından bu sistem kendi bünyelerinde kurulabilir.","Türkiye'de sadece veteriner tıbbi ürün ve beşeri tıbbi ürünler devlet nezdinde zorunluluk gerektirdiği için bu GMP kılavuzları var.","GMP mantığı ihtiyaca binaen gitgide büyüyen bir kılavuzlar zinciri olup, tarım, laboratuvar, dökümantasyon, ticaret, dağıtım, yem güvenliği, hijyen ve bilgisayarlı sistemler gibi alanlarda da benzer kılavuzlar bulunmaktadır."]},"beginTime":1075,"endTime":1185,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1075&ask_summarization=1"},{"index":9,"title":"GMP Temel İlkeleri","list":{"type":"unordered","items":["GMP temel ilkeleri, bir işletme GMP ile bir GMPli bir işletme olmak istiyorsa uyması gereken dokuz temel ilkeyi içerir.","GMP temel ilkelerinin ilki kalite yönetimi olup, ürünün amaçlanmış kullanımına uygun olarak, kalite ve etkinlik yönünden kullanıcı riske sokmayacak şekilde üretilmesini ister.","GMP'de kalite güvence anlayışı vardır ve bir ürünün amacına uygun olarak üretildiğinden emin olmak ve buna güvenmek için uygulanan sistematik ve organize edilmiş işlemleri ifade eder."]},"beginTime":1185,"endTime":1421,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1185&ask_summarization=1"},{"index":10,"title":"Kalite Güvence ve Kalite Yönetim Sistemi","list":{"type":"unordered","items":["Kalite güvence, hammadde tedarikten kalite kontrol sonuçlarına kadar olan bütün kısımların hepsini kapsayarak ürünlerin toplam kalitesini sağlamakla görevlidir.","Kalite yönetim sistemi oturttuktan ve kalite güvencemizi kurduktan sonra, bu sistemlere dahil olacak personellere geçilir."]},"beginTime":1421,"endTime":1501,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1421&ask_summarization=1"},{"index":11,"title":"Cip'in Temel İlkeleri ve Kilit Personel","list":{"type":"unordered","items":["Cip'in temel ilkelerinin ikinci maddesi, tatmin edici bir kalite güvence sisteminin ve yürütülmesinin kişilere bağlı olduğunu belirtir.","GMP temel ilkelerinde kilit personeller belirlenmiştir ve yönetimin sistemin sorumluluğu tamamen bu kilit personeller üzerindedir.","Kilit personeller sorumlu yöneticiler, mesul müdürler, üretim sorumluları, kalite kontrol sorumluları ve kalite güvence sorumlularıdır."]},"beginTime":1506,"endTime":1578,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1506&ask_summarization=1"},{"index":12,"title":"Personel İçin Yönetimden Beklenenler","list":{"type":"unordered","items":["Cipli bir tesiste yönetimden yeterli sayıda kalifiye personel olması beklenir, çünkü yeterli sayıda personel çok daha önemlidir.","Cihanp'in kuralına göre bir kişiye yapabileceğinden daha fazla iş verilemez, verilirse kaliteyi riske sokar.","Her personel için belirlenmiş görev tanımı olması ve planlanmış eğitimlerin olması gerekir."]},"beginTime":1578,"endTime":1639,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1578&ask_summarization=1"},{"index":13,"title":"Eğitim ve Personel Sorumluluğu","list":{"type":"unordered","items":["Cipli bir tesiste işe alınan kişilerin kesinlikle belirli eğitimlerden geçmesi gerekir, bunların başı Cip temel eğitimidir.","Eğitimler sektörüne göre değişir; asseptik sahada çalışanlar asseptik alanlara giriş çıkış kuralları, gıda tesisinde çalışanlar temel hijyen ve gıdaya temas eden maddeler, laboratuvarda çalışanlar laboratuvar güvenliği eğitimlerini almış olmalıdır.","Eğitim almış personellerin takibi gerekir, verilen eğitimlerin etkili olup olmadığı ve kişilere geçip geçmediği kontrol edilmelidir."]},"beginTime":1639,"endTime":1732,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1639&ask_summarization=1"},{"index":14,"title":"Personelden Beklenenler","list":{"type":"unordered","items":["Personelden, ona verilmiş olan görev tanımı kapsamında verilen eğitimlere riayet ederek sürekli gelişime açık bir davranış sergilemesi beklenir.","GMP eğitime dirençli, dökümana dirençli personelleri bünyesinde barındırmayı istemez.","Bir işi uzun yıllardır başarılı bir şekilde yapıyor olabilirsiniz ama sürekli gelişime açık, sürekli eğitimlere açık ve yeniliklere açık bir şekilde davranmanız gerekir."]},"beginTime":1732,"endTime":1789,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1732&ask_summarization=1"},{"index":15,"title":"Tesis ve Ekipman Durumu","list":{"type":"unordered","items":["Üretime ve prosese uygun tesis, tüm alanların üretim ve personel açısından konforun sağlanması ve doğru ekipman seçimi gereklidir.","Tesis temizlik, dezenfeksiyonu uygun olmalı, çapraz bulaşmaya izin vermeyecek şekilde tasarlanmış olmalı ve büyümeye açık dizayn edilmiş olmalıdır.","Tesis dış zararlılara korunaklı olmalı ve pes kontrol sistemi zayıf olmamalıdır."]},"beginTime":1789,"endTime":1899,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1789&ask_summarization=1"},{"index":16,"title":"Personel Konforu ve Doğru Ekipman Seçimi","list":{"type":"unordered","items":["Personel açısından konforlu bir çalışma sahası gereklidir; sıcaklık, nem, basınç dengeleri ürünü ve personeli riske atmayacak şekilde ayarlanmalıdır.","Uygun aydınlatma, ses seviyeleri ve personelin sağlığını riske atmayan çalışma ortamı sağlanmalıdır.","Doğru ekipman, prosesi riske atmayacak ekipmandır ve tüm ekipmanların temizlik ve bakım planlamalarının yapılmış olması gerekir."]},"beginTime":1899,"endTime":1995,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=1899&ask_summarization=1"},{"index":17,"title":"Dökümantasyon Sisteminin Özellikleri","list":{"type":"unordered","items":["Dökümantasyon sisteminde yalın ve anlaşılır bir dille yazılmış dökümanların olması gerekir, çünkü okuyacak kişiler ilkokul mezunu olabilir.","Dökümanlar hatasız, ulaşılabilir ve yazılı halde bulunmalıdır, ayrıca gözden geçirmeye uygun şekilde tasarlanmalıdır.","Dökümanlar yapılan işi kesinlikle yansıtmalı, aksi takdirde yapılan iş yazılan işi tamamlamaz ve örtüşmez."]},"beginTime":2001,"endTime":2163,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=2001&ask_summarization=1"},{"index":18,"title":"Temel Dökümanlar","list":{"type":"unordered","items":["Standart işlem prosedürleri (SOP) her bir işlem için yazılmalı, uygulamalar için talimatlar hazırlanmalıdır.","Cihaz kullanımları, temizlikler, hammaddelerin ve bitmiş ürünlerin spesifikasyonları (kimliği) yazılı ve onaylı olmalıdır.","Seri üretim, beş üretim veya bant üretim için kayıtlar aktarılmalı, hammaddeden bitmiş ürüne kadar olan süreç dökümante edilmelidir."]},"beginTime":2163,"endTime":2236,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=2163&ask_summarization=1"},{"index":19,"title":"Kalite Güvencesi ve Dökümantasyon","list":{"type":"unordered","items":["Kaliteli bir dökümantasyon sistemi için güçlü bir kalite güvence sistemi gereklidir.","Kalite yönetim sistemi kurulduktan, personel eğitildikten ve ekipmanlar CIP'ye göre tasarlandıktan sonra üretim, depolama ve dağıtıma geçilebilir.","CIP hammadde kabulden bitmiş ürünün tüketiciye ulaşmasına kadar geçen süreyi kontrol altında olmasını ve yazılı prosedürlere göre işlem yapılmasını ister."]},"beginTime":2236,"endTime":2307,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=2236&ask_summarization=1"},{"index":20,"title":"Yazılı Prosedürlerin Önemi","list":{"type":"unordered","items":["Yazılı prosedürler işlemlere göre olmadığı zaman, özellikle yeni personel işe alındığında, iş yapamamış personel konumuna düşebilir.","Yazılı prosedürlere göre işlem yapılmadığı zaman sistem sadece kişiler üzerinden yürümüş olur, bu da yönetim sisteminin kabul etmediği bir şeydir.","Bir ürüne uygun belgelenmiş, test edilmiş hammaddeler kullanılmalı, çapraz bulaşmaya izin verilmemeli ve sistemler GMP kurallarına göre valide edilmelidir."]},"beginTime":2307,"endTime":2412,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=2307&ask_summarization=1"},{"index":21,"title":"Üretim ve Depolama Koşulları","list":{"type":"unordered","items":["Üretim kayıtları anlık olarak tutulmalıdır, aksi takdirde zamanla unutulabilir.","Teknik ekipler, kalite güvence, kalite kontrol ve diğer departmanların üretim hattına müdahalesi olacaksa, ürünü ve personeli riske atmayacak şekilde davranmalıdır.","Depolama koşulları tanımlanmış, uygun ve takip edilebilir olmalıdır, özellikle bitmiş ürünlerin sıcaklık haritalaması sürekli test edilmelidir."]},"beginTime":2412,"endTime":2463,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=2412&ask_summarization=1"},{"index":22,"title":"Etiketler ve Kalite Kontrol","list":{"type":"unordered","items":["Etiketler tanımlı olmalı ve doğru kullanılmalıdır, sadece bitmiş üründe değil süreç içerisinde de birçok etiket kullanılır.","Etiket hatalarından dolayı tanımlanmamış, düşmüş veya kusurlu etiketler kuruluşların başına kötü tecrübeler getirebilir.","Kalite kontrol için CIP'nin en büyük temel ilkesi üretimden bağımsız olmasıdır, hammadde, bitmiş ürün, validasyon kontrolleri ve personel hijyen kontrolleri gibi birçok test işi vardır."]},"beginTime":2463,"endTime":2622,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=2463&ask_summarization=1"},{"index":23,"title":"Laboratuvar Uygulamaları","list":{"type":"unordered","items":["Laboratuvarlar için CIP yerine daha çok CIP (İyi Laboratuvar Uygulamaları) odaklı çalışmalar tavsiye edilir.","Her bağımsız laboratuvarın CIP odaklı çalışması önemlidir, CIP belgesi olabilir olmayabilir.","Kalite kontrol personelinin veya kalite güvencede çalışmak isteyen herkesin en azından CIP eğitimini alıp vizyonunu o doğrultuda geliştirmesi hem kendi içi işi için hem de laboratuvarın geliştirmesi için önemlidir."]},"beginTime":2622,"endTime":2701,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=2622&ask_summarization=1"},{"index":24,"title":"Dış Hizmetlerin Kontrolü","list":{"type":"unordered","items":["Dışarıdan alınan her hizmet (analiz, yarı mamüller, eğitim, validasyon) ürününüzün kalitesine üçüncü bir kişinin elinin değmesi demektir.","Kontratlı sözleşmeler ve imzalı anlaşmalar yapılması, tüm detayların net belirtilmesi ve yeterliliklerin sağlanmaması durumunda anlaşma yapılmaması tavsiye edilir.","Ürün kalite gözden geçirmeleri ve kontratlar gözden geçirilmeli, gerekirse firma değiştirilmeli veya yeniden konuşulmalıdır."]},"beginTime":2706,"endTime":2789,"href":"/video/preview/7609113414410093090?parent-reqid=1765156637760461-15297731267353741420-balancer-l7leveler-kubr-yp-klg-40-BAL&text=Gmpta&t=2706&ask_summarization=1"},{"index":25,"title":"Şikayet ve Geri Çekme Süreçleri","list":{"type":"unordered","items":["Kullanıcıların sahadan gelen şikayetlerin alınması, değerlendirilmesi ve sonuçlandırılmasını içeren bir prosedürün olması gerekir.","Şikayetler şeffaf ve objektif bir şekilde değerlendirilmeli, kanıtlarla dönüş yapılmalıdır.","Hatalı veya hatalı olması muhtemel ürünlerin geri çekilmesi için en kötü koşullara göre simülasyon yapılmalı ve yol haritası 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