{"id":17992,"date":"2026-09-03T01:18:47","date_gmt":"2026-09-03T01:18:47","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17992"},"modified":"2026-09-07T01:33:14","modified_gmt":"2026-09-07T01:33:14","slug":"sop-for-temperature-and-humidity-monitoring-in-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-temperature-and-humidity-monitoring-in-pharmaceutical-industry\/","title":{"rendered":"\u0130la\u00e7 End\u00fcstrisinde S\u0131cakl\u0131k ve Nem \u0130zleme Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"
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\u0130la\u00e7 End\u00fcstrisinde S\u0131cakl\u0131k ve Nem \u0130zleme Konusunda Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc.<\/p>

\"\u0130la\u00e7
\u0130la\u00e7 End\u00fcstrisinde S\u0131cakl\u0131k ve Nem \u0130zleme Standart Prosed\u00fcr\u00fc.<\/strong><\/em><\/figcaption><\/figure>

1.0 AMA\u00c7:<\/strong><\/h2>

\u0130la\u00e7 fabrikas\u0131 genelindeki \u00fcretim, depolama ve laboratuvar alanlar\u0131nda s\u0131cakl\u0131k ve ba\u011f\u0131l nemin rutin olarak izlenmesi, kaydedilmesi ve incelenmesine ili\u015fkin prosed\u00fcr\u00fc belirlemek.<\/p>

2.0 KAPSAM:<\/strong><\/h2>

Bu Prosed\u00fcr, \u00fcretim salonlar\u0131, hammadde depolar\u0131, bitmi\u015f \u00fcr\u00fcn depolar\u0131, karantina odalar\u0131, so\u011fuk hava depolar\u0131, laboratuvarlar, stabilite odalar\u0131 ve \u00fcr\u00fcn kalitesinin \u00e7evresel ko\u015fullardan etkilenebilece\u011fi hava kilitleri dahil olmak \u00fczere t\u00fcm s\u0131n\u0131fland\u0131r\u0131lm\u0131\u015f ve kontroll\u00fc alanlar\u0131 kapsamaktad\u0131r.<\/p>

3.0 SORUMLULUK:<\/strong><\/h2>

B\u00f6lge Operat\u00f6r\u00fc, Kalite G\u00fcvence Sorumlusu ve Depo Sorumlusu<\/p>

4.0 SORUMLULUK:<\/strong><\/h2>

Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc.<\/p>

5.0 \u0130\u015eLEM:<\/strong><\/h2>

5.1 Her vardiya ba\u015flang\u0131c\u0131nda g\u00fcnl\u00fck izleme program\u0131n\u0131 g\u00f6zden ge\u00e7irin. Programda her bir konum, sens\u00f6r kimli\u011fi, okuma saati ve her tur i\u00e7in g\u00f6revli ki\u015fi listelenmi\u015ftir.<\/p>

5.2 Kalite G\u00fcvencesi (QA) ofisinden S\u0131cakl\u0131k ve Nem Kay\u0131t Defterini al\u0131n. Her alan\u0131n, g\u00fcnl\u00fck kay\u0131tlar i\u00e7in \u00f6nceden bas\u0131lm\u0131\u015f sat\u0131rlar\u0131 bulunan kendi kay\u0131t defteri vard\u0131r.<\/p>

5.3 Kalibre edilmi\u015f t\u00fcm termohigrometrelerin ve dijital veri kaydedicilerin \u00e7al\u0131\u015f\u0131r durumda olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. Ar\u0131zal\u0131 herhangi bir cihaz, izleme turu ba\u015flamadan \u00f6nce Kalite G\u00fcvencesi birimine bildirilmelidir.<\/p>

5.4 Kalite G\u00fcvence ofisinden ba\u015flayan g\u00fczerg\u00e2h haritas\u0131n\u0131 takip ederek her bir alan\u0131 do\u011fru s\u0131rayla ge\u00e7in. Bu g\u00fczerg\u00e2h, temiz ve daha az temiz b\u00f6lgeler aras\u0131ndaki \u00e7apraz kontaminasyon riskini s\u0131n\u0131rlamak \u00fczere tasarlanm\u0131\u015ft\u0131r.<\/p>

5.5 Kabul S\u0131n\u0131rlar\u0131:<\/strong><\/h3>

5.5.1 Her alan\u0131n s\u0131cakl\u0131k ve nem a\u00e7\u0131s\u0131ndan kendine \u00f6zg\u00fc kabul s\u0131n\u0131rlar\u0131 vard\u0131r. Bu s\u0131n\u0131rlar, \u00fcr\u00fcn kararl\u0131l\u0131k verileri ve GMP gereklilikleri temel al\u0131narak belirlenir.<\/p>

5.5.2 Ortak alanlar i\u00e7in standart s\u0131n\u0131rlar \u015funlard\u0131r:<\/strong><\/h4>

5.5.2.1 Genel \u00fcretim ve paketleme alanlar\u0131: S\u0131cakl\u0131k 20 ila 25 \u00b0C, Ba\u011f\u0131l Nem (RH) 45 ila 65%.<\/p>

5.5.2.2 Hammadde depolar\u0131 ve mamul depolar\u0131: S\u0131cakl\u0131k 25 \u00b0C\u2019nin alt\u0131nda, ba\u011f\u0131l nem \u2019\u0131n alt\u0131nda.<\/p>

5.5.2.3 So\u011fuk hava deposu (2 ila 8 \u00b0C\u2019lik odalar): S\u0131cakl\u0131k 2 ila 8 \u00b0C; ba\u011f\u0131l nem kritik \u00f6neme sahip de\u011fildir, ancak kay\u0131t amac\u0131yla kaydedilir.<\/p>

5.5.2.4 S\u0131cakl\u0131\u011f\u0131 kontroll\u00fc laboratuvarlar: S\u0131cakl\u0131k 20 ila 25 \u00b0C, ba\u011f\u0131l nem 30 ila 65%.<\/p>

5.5.2.5 Stabilite odalar\u0131: Ayar de\u011ferleri, ICH ko\u015fullar\u0131na g\u00f6re de\u011fi\u015fiklik g\u00f6sterir (25 \u00b0C\/60% ba\u011f\u0131l nem, 30 \u00b0C\/65% ba\u011f\u0131l nem, 40 \u00b0C\/75% ba\u011f\u0131l nem).<\/p>

5.5.3 Belirli \u00fcr\u00fcnler veya s\u00fcre\u00e7ler i\u00e7in daha kat\u0131 s\u0131n\u0131rlar ge\u00e7erli olabilir. Her zaman yukar\u0131daki genel de\u011ferleri de\u011fil, alan\u0131n duyuru panosunda belirtilen s\u0131n\u0131rlara uyun.<\/p>

5.5.4 Her alan i\u00e7in bir uyar\u0131 s\u0131n\u0131r\u0131, eylem s\u0131n\u0131r\u0131n\u0131n i\u00e7inde yer al\u0131r. Uyar\u0131 s\u0131n\u0131r\u0131n\u0131 a\u015fan bir \u00f6l\u00e7\u00fcm de\u011feri, izleme protokol\u00fcn\u00fc tetikler. Eylem s\u0131n\u0131r\u0131n\u0131 a\u015fan bir \u00f6l\u00e7\u00fcm de\u011feri ise sapma raporunu tetikler.<\/p>

5.6 \u0130zleme S\u0131kl\u0131\u011f\u0131:<\/strong><\/h3>

5.6.1 \u00c7o\u011fu alanda, vardiya ba\u015f\u0131na iki kez manuel \u00f6l\u00e7\u00fcm yap\u0131l\u0131r. \u0130lk \u00f6l\u00e7\u00fcm, vardiyan\u0131n ilk saati i\u00e7inde ger\u00e7ekle\u015ftirilir. \u0130kinci \u00f6l\u00e7\u00fcm ise vardiyan\u0131n son saati i\u00e7inde ger\u00e7ekle\u015ftirilir.<\/p>

5.6.2 So\u011fuk odalar ve steril odalar gibi y\u00fcksek riskli alanlarda, s\u00fcrekli elektronik kay\u0131t tutman\u0131n yan\u0131 s\u0131ra saat ba\u015f\u0131 manuel kontroller yap\u0131lmal\u0131d\u0131r.<\/p>

5.6.3 Kararl\u0131l\u0131k odalar\u0131ndaki veriler, dahili veri kaydedici taraf\u0131ndan her 15 dakikada bir kaydedilir. Bununla birlikte, g\u00fcnde iki kez manuel do\u011frulama \u00f6l\u00e7\u00fcm\u00fc de al\u0131nmaktad\u0131r.<\/p>

5.6.4 Depolama alanlar\u0131ndaki s\u00fcrekli veri kaydediciler, 24 saat boyunca 5 dakikal\u0131k aral\u0131klarla kay\u0131t yapmaktad\u0131r. Veriler, e\u011filim analizi amac\u0131yla haftal\u0131k olarak indirilmektedir.<\/p>

5.6.5 A\u015fa\u011f\u0131daki tetikleme ko\u015fullar\u0131 alt\u0131nda ek \u00f6l\u00e7\u00fcmler yap\u0131lmas\u0131 gerekmektedir:<\/p>

5.6.5.1 Bir HVAC sisteminin yeniden ba\u015flat\u0131lmas\u0131ndan veya planl\u0131 kapat\u0131lmas\u0131ndan sonra.<\/p>

5.6.5.2 Binalar\u0131n iklim kontrol\u00fcn\u00fc etkileyen \u015fiddetli hava olaylar\u0131 s\u0131ras\u0131nda.<\/p>

5.6.5.3 Herhangi bir kap\u0131 10 dakikadan fazla a\u00e7\u0131k b\u0131rak\u0131ld\u0131\u011f\u0131nda.<\/p>

5.6.5.4 Y\u00fczeylerde g\u00f6zle g\u00f6r\u00fcl\u00fcr bir yo\u011fu\u015fma veya don tabakas\u0131 olu\u015ftu\u011funda.<\/p>

5.6.5.5 Herhangi bir hava i\u015fleme \u00fcnitesinde bak\u0131m \u00e7al\u0131\u015fmas\u0131 yap\u0131ld\u0131ktan sonra.<\/p>

5.7 \u0130zleme Ara\u00e7lar\u0131:<\/strong><\/h3>

5.7.1 Duvara Monte Termohigrometreler:<\/b><\/strong><\/h4>

5.7.1.1 \u0130zlenen her alanda en az bir adet kalibre edilmi\u015f, duvara monte termohigrometre bulunur. Cihaz, dijital ekran\u0131nda o anki s\u0131cakl\u0131\u011f\u0131 ve ba\u011f\u0131l nemi g\u00f6sterir.<\/p>

5.7.1.2 \u00dcnite, zeminden 1,5 ila 1,8 metre y\u00fckseklikte monte edilir. Bu y\u00fckseklik, s\u00f6z konusu alandaki tipik \u00e7al\u0131\u015fma b\u00f6lgesine uygundur.<\/p>

5.7.1.3 Cihaz\u0131 kap\u0131lardan, havaland\u0131rma deliklerinden, \u0131s\u0131 kaynaklar\u0131ndan veya d\u0131\u015f duvarlardan en az 1 metre uzakta tutun. Bunlar\u0131n herhangi biri, yanl\u0131\u015f bir yerel \u00f6l\u00e7\u00fcm sonucuna yol a\u00e7abilir.<\/p>

5.7.1.4 \u0130zleme turu s\u0131ras\u0131nda her bir \u00fcnitedeki kalibrasyon etiketini kontrol edin. Kalibrasyon tarihi ge\u00e7mi\u015f bir \u00fcnite, resmi \u00f6l\u00e7\u00fcmler i\u00e7in kullan\u0131lamaz.<\/p>

5.7.2 Ta\u015f\u0131nabilir Referans Termohigrometreler:<\/b><\/strong><\/h4>

5.7.2.1 Kalite G\u00fcvence g\u00f6revlisi, anl\u0131k kontroller ve duvar tipi cihazlarla \u00e7apraz do\u011frulama yapmak \u00fczere ta\u015f\u0131nabilir bir referans cihaz\u0131 yan\u0131nda bulundurur.<\/p>

5.7.2.2 Ta\u015f\u0131nabilir \u00fcnite, daha s\u0131k\u0131 bir kalibrasyon program\u0131na sahiptir ve \u00f6l\u00e7\u00fcm de\u011ferleriyle ilgili her t\u00fcrl\u00fc ihtilaf durumunda ana referans g\u00f6revi g\u00f6r\u00fcr.<\/p>

5.7.2.3 Bir \u00f6l\u00e7\u00fcm kaydetmeden \u00f6nce, ta\u015f\u0131nabilir \u00fcnitenin yeni bir alanda en az 10 dakika boyunca dengeye gelmesine izin verin. H\u0131zl\u0131 alan de\u011fi\u015fiklikleri ge\u00e7ici sapmalara neden olabilir.<\/p>

5.7.2.4 Probu dikkatli bir \u015fekilde kullan\u0131n. Sens\u00f6r ucuna dokunmay\u0131n. V\u00fccut \u0131s\u0131s\u0131, s\u0131cakl\u0131k de\u011ferini birka\u00e7 dakika boyunca y\u00fckseltecektir.<\/p>

5.7.3 S\u00fcrekli Veri Kaydediciler:<\/b><\/strong><\/h4>

5.7.3.1 Veri kaydediciler, depolama alanlar\u0131na yerle\u015ftirilen ve sabit aral\u0131klarla s\u0131cakl\u0131k ve ba\u011f\u0131l nemi kaydetmeye yarayan, pille \u00e7al\u0131\u015fan k\u00fc\u00e7\u00fck cihazlard\u0131r.<\/p>

5.7.3.2 Her bir kay\u0131t cihaz\u0131, kendisini belirli bir konuma ba\u011flayan benzersiz bir kimlik numaras\u0131 ta\u015f\u0131r. De\u011fi\u015fiklik kontrol formu olmadan kay\u0131t cihaz\u0131n\u0131 bir b\u00f6lgeden di\u011ferine ta\u015f\u0131may\u0131n\u0131z.<\/p>

5.7.3.3 \u00dcretici yaz\u0131l\u0131m\u0131n\u0131 kullanarak kay\u0131t cihaz\u0131 verilerini haftal\u0131k olarak indirin. Her indirme dosyas\u0131n\u0131, dosya ad\u0131na kay\u0131t cihaz\u0131 kimli\u011fi, konum ve tarihi ekleyerek kaydedin. Haftal\u0131k dosya, Haftal\u0131k Veri Kay\u0131t Cihaz\u0131 \u0130ndirme Raporunun bir par\u00e7as\u0131n\u0131 olu\u015fturur.<\/p>

5.7.3.4 \u0130ndirilen verileri inceleyerek, uyar\u0131 veya eylem s\u0131n\u0131r\u0131n\u0131 a\u015fan herhangi bir de\u011fer olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. Her bir sapmay\u0131 ba\u015flang\u0131\u00e7 saati, biti\u015f saati ve s\u00fcresi ile i\u015faretleyin.<\/p>

5.7.3.5 Pil seviyesi d\u00fc\u015f\u00fck g\u00f6stergesi yand\u0131\u011f\u0131nda kay\u0131t cihaz\u0131n\u0131n pilini de\u011fi\u015ftirin. Pilin bitmesi nedeniyle olu\u015fan veri bo\u015flu\u011fu, bir sapma olarak rapor edilmelidir.<\/p>

5.7.4 Bina Y\u00f6netim Sistemi (BMS) Sens\u00f6rleri:<\/b><\/strong><\/h4>

5.7.4.1 BMS, iklimlendirme sistemi ile kontrol edilen her alan\u0131 merkezi bir izleme istasyonuna ba\u011flar. Bu istasyon, t\u00fcm sens\u00f6rlerden gelen canl\u0131 \u00f6l\u00e7\u00fcm de\u011ferlerini tek bir ekranda g\u00f6sterir.<\/p>

5.7.4.2 Herhangi bir \u00f6l\u00e7\u00fcm de\u011feri bir uyar\u0131 veya m\u00fcdahale s\u0131n\u0131r\u0131n\u0131 a\u015ft\u0131\u011f\u0131nda, BMS g\u00f6revli m\u00fchendise otomatik bir alarm g\u00f6nderir.<\/p>

5.7.4.3 Sabah turu s\u0131ras\u0131nda her alan i\u00e7in BMS de\u011ferlerini duvara monte edilmi\u015f ekrandaki de\u011ferlerle kar\u015f\u0131la\u015ft\u0131r\u0131n. 1 \u00b0C veya 5% ba\u011f\u0131l nemden fazla bir sapma olmas\u0131 durumunda servis \u00e7a\u011f\u0131r\u0131lmas\u0131 gerekir.<\/p>

5.7.4.4 G\u00fcnl\u00fck BMS Raporunu her g\u00fcn saat 08.00\u2019de yazd\u0131r\u0131n. Yazd\u0131r\u0131lan raporu, kalite g\u00fcvencesi incelemesinin ard\u0131ndan g\u00fcnl\u00fck izleme klas\u00f6r\u00fcne koyun.<\/p>

5.8 \u00d6l\u00e7\u00fcm Almak:<\/strong><\/h3>

5.8.1 Alana uygun hava kilidinden girin ve o b\u00f6lgeye ait giyinme prosed\u00fcr\u00fcn\u00fc izleyin.<\/p>

5.8.2 V\u00fccudunuzla sens\u00f6r\u00fc engellemeyecek \u015fekilde termohigrometrenin \u00f6n\u00fcne ge\u00e7in. V\u00fccut \u0131s\u0131s\u0131 ve nefes, \u00f6l\u00e7\u00fcm sonu\u00e7lar\u0131n\u0131 etkileyebilir.<\/p>

5.8.3 Ekran\u0131n sabitlenmesini beklemek i\u00e7in 30 saniye bekleyin. Dijital cihazlar, alan durumundaki bir de\u011fi\u015fiklik s\u0131ras\u0131nda bazen iki de\u011fer aras\u0131nda titreyebilir.<\/p>

5.8.4 \u00d6nce s\u0131cakl\u0131\u011f\u0131, ard\u0131ndan nemi okuyun. Her iki de\u011feri de ondal\u0131k basama\u011fa kadar, o anki zaman aral\u0131\u011f\u0131na ait kay\u0131t defteri sat\u0131r\u0131na kaydedin.<\/p>

5.8.5 Her bir de\u011ferin yan\u0131na sens\u00f6r kimli\u011fini, okuma zaman\u0131n\u0131 ve operat\u00f6r kimli\u011finizi yaz\u0131n\u0131z. Her bir giri\u015f, belirli bir sens\u00f6re ve ki\u015fiye kadar izlenebilir olmal\u0131d\u0131r.<\/p>

5.8.6 Kay\u0131t defterine giri\u015f yaparken yaln\u0131zca mavi veya siyah m\u00fcrekkep kullan\u0131n. Asla kur\u015fun kalem kullanmay\u0131n. Asla d\u00fczeltme s\u0131v\u0131s\u0131 kullanmay\u0131n. Herhangi bir hatay\u0131 d\u00fczeltmek i\u00e7in yanl\u0131\u015f giri\u015fin \u00fczerine tek bir \u00e7izgi \u00e7ekin, ard\u0131ndan do\u011fru de\u011feri ba\u015f harfiniz ve tarihi ile birlikte yaz\u0131n.<\/p>

5.8.7 \u00d6l\u00e7\u00fcmler tamamland\u0131ktan sonra sat\u0131r\u0131 imzalay\u0131n ve tarih at\u0131n. \u0130mzas\u0131z bir sat\u0131r ge\u00e7erli bir kay\u0131t olarak kabul edilmez.<\/p>

5.9 Gezi Y\u00f6netimi:<\/strong><\/h3>

5.9.1 Sapma, s\u00f6z konusu alan i\u00e7in belirlenen eylem s\u0131n\u0131r\u0131n\u0131n d\u0131\u015f\u0131nda kalan her t\u00fcrl\u00fc \u00f6l\u00e7\u00fcm de\u011feridir. Her sapma ara\u015ft\u0131r\u0131lmal\u0131 ve belgelenmelidir.<\/p>

5.9.2 Bir sapma tespit edildi\u011finde, a\u015fa\u011f\u0131daki ad\u0131mlar\u0131 s\u0131rayla uygulay\u0131n:<\/p>

5.9.2.1 Sens\u00f6r ar\u0131zas\u0131n\u0131 ekarte etmek i\u00e7in ta\u015f\u0131nabilir referans \u00fcnitesini kullanarak ikinci bir \u00f6l\u00e7\u00fcm yap\u0131n.<\/p>

5.9.2.2 \u0130kinci okuma da ba\u015far\u0131s\u0131z olursa, 15 dakika i\u00e7inde Kalite G\u00fcvencesi birimine ve vardiya amirine haber verin.<\/p>

5.9.2.3 B\u00f6lgedeki herhangi bir \u00fcr\u00fcn\u00fcn s\u0131n\u0131r d\u0131\u015f\u0131 ko\u015fullara maruz kal\u0131p kalmad\u0131\u011f\u0131n\u0131 kontrol edin. Etkilenen t\u00fcm \u00fcr\u00fcnleri, kalite g\u00fcvencesi incelemesi tamamlanana kadar karantinaya al\u0131n.<\/p>

5.9.2.4 Sapman\u0131n temel nedenini ara\u015ft\u0131rmas\u0131 i\u00e7in HVAC m\u00fchendisine bildirimde bulunun.<\/p>

5.9.2.5 Alan, s\u0131n\u0131r de\u011ferlerin i\u00e7ine geri d\u00f6nene kadar 30 dakikal\u0131k aral\u0131klarla izlemeye devam edin.<\/p>

5.9.3 \u00c7evresel Gezi Formu\u2019na geziyle ilgili bilgileri kaydedin. Formda tarih, saat, s\u00fcre, alan, sens\u00f6r kimli\u011fi, \u00f6l\u00e7\u00fcm de\u011feri, eylem s\u0131n\u0131r\u0131 ve \u00fcr\u00fcn etkisi bilgileri yer almal\u0131d\u0131r.<\/p>

5.9.4 Olaydan sonraki 24 saat i\u00e7inde formu Kalite G\u00fcvencesi (QA) birimine g\u00f6nderin. Kalite G\u00fcvencesi (QA) birimi, stabilite verilerine dayanarak etkilenen \u00fcr\u00fcnlerin piyasaya s\u00fcr\u00fclme durumuna ili\u015fkin karar verecektir.<\/p>

5.9.5 4 saati a\u015fan veya bitmi\u015f \u00fcr\u00fcn\u00fc etkileyen bir durum, tesis sapma SOP\u2019si kapsam\u0131nda resmi bir sapma raporunun haz\u0131rlanmas\u0131n\u0131 gerektirir.<\/p>

5.10 Cihazlar\u0131n Kalibrasyonu:<\/strong><\/h3>

5.10.1 T\u00fcm termohigrometreler ve veri kaydediciler, yetkili bir d\u0131\u015f kurulu\u015f taraf\u0131ndan veya tesisin kalibrasyon laboratuvar\u0131 taraf\u0131ndan kalibre edilmelidir.<\/p>

5.10.2 Kalibrasyon s\u0131kl\u0131\u011f\u0131, duvara monte edilen \u00fcniteler i\u00e7in alt\u0131 ayda bir, ta\u015f\u0131nabilir referans \u00fcniteler i\u00e7in ise \u00fc\u00e7 ayda birdir.<\/p>

5.10.3 Veri kaydediciler, iki s\u0131cakl\u0131k noktas\u0131nda (\u00e7al\u0131\u015fma aral\u0131\u011f\u0131n\u0131n alt ve \u00fcst s\u0131n\u0131rlar\u0131nda) ve iki nem noktas\u0131nda (standart doymu\u015f tuz referanslar\u0131yla e\u015fle\u015fen 33% RH ve 75% RH de\u011ferlerinde) kalibre edilir.<\/p>

5.10.4 Her bir cihaz i\u00e7in bir Cihaz Kalibrasyon Sertifikas\u0131 d\u00fczenlenir. Sertifikada, ba\u015flang\u0131\u00e7taki de\u011ferler, son durumdaki de\u011ferler ve uygulanan d\u00fczeltme fakt\u00f6rleri belirtilir.<\/p>

5.10.5 Ba\u015far\u0131l\u0131 bir kalibrasyonun ard\u0131ndan her bir cihaza bir kalibrasyon etiketi yap\u0131\u015ft\u0131r\u0131n. Etikette kalibrasyon tarihi, bir sonraki kalibrasyon tarihi ve sertifika numaras\u0131 belirtilir.<\/p>

5.10.6 Kalibrasyon testinden ge\u00e7emeyen bir cihaz derhal kullan\u0131mdan kald\u0131r\u0131l\u0131r ve onar\u0131m veya de\u011fi\u015ftirme amac\u0131yla g\u00f6nderilir. Kalibrasyon testinden ge\u00e7ememe durumu, son ba\u015far\u0131l\u0131 testten bu yana elde edilen verilerin geriye d\u00f6n\u00fck olarak incelenmesini gerektirebilir.<\/p>

5.11 Veri \u0130nceleme ve E\u011filim Analizi:<\/strong><\/h3>

5.11.1 Kalite G\u00fcvencesi (QA), her g\u00fcnl\u00fck kay\u0131t defteri giri\u015fini bir sonraki i\u015f g\u00fcn\u00fcn\u00fcn sonuna kadar inceler. \u0130mzal\u0131 bir inceleme raporu, t\u00fcm \u00f6l\u00e7\u00fcm de\u011ferlerinin s\u0131n\u0131rlar i\u00e7inde oldu\u011funu teyit eder.<\/p>

5.11.2 Her bir alan i\u00e7in haftal\u0131k veri kaydedici verileri bir e\u011filim grafi\u011fine i\u015flenir. Grafik, her g\u00fcn i\u00e7in en y\u00fcksek, en d\u00fc\u015f\u00fck ve ortalama de\u011ferleri g\u00f6sterir.<\/p>

5.11.3 Kalite G\u00fcvencesi (QA) bir Ayl\u0131k Trend Raporu haz\u0131rlar. Rapor, herhangi bir s\u0131n\u0131r a\u015f\u0131m\u0131 meydana gelmemi\u015f olsa bile, eylem s\u0131n\u0131rlar\u0131na do\u011fru bir sapma g\u00f6steren t\u00fcm alanlar\u0131 i\u015faretler.<\/p>

5.11.4 \u00dc\u00e7 ayl\u0131k y\u00f6netim inceleme komitesi, t\u00fcm Ayl\u0131k Trend Raporlar\u0131n\u0131 inceler. Sistemik sorunlara sorumlu ki\u015filer atan\u0131r ve d\u00fczeltme i\u00e7in hedef tarihler belirlenir.<\/p>

5.11.5 T\u00fcm s\u0131cakl\u0131k ve nem kay\u0131tlar\u0131, en az be\u015f y\u0131l veya \u00fcr\u00fcn\u00fcn raf \u00f6mr\u00fc art\u0131 bir y\u0131l s\u00fcreyle saklan\u0131r; bu s\u00fcrelerden hangisi daha uzunsa o s\u00fcre ge\u00e7erlidir.<\/p>

5.12 KAYIT:<\/strong><\/h3>

5.12.1 S\u0131cakl\u0131k ve Nem Kay\u0131t Defteri.<\/p>

5.12.2 G\u00fcnl\u00fck BMS Raporu<\/strong><\/h4>

5.12.3 Haftal\u0131k Veri Kaydedici \u0130ndirme Raporu.<\/p>

5.12.4 \u00c7evre Gezisi Formu.<\/p>

5.12.5 Cihaz Kalibrasyon Sertifikas\u0131.<\/p>

5.12.6 Ayl\u0131k Trend Raporu.<\/p>

6.0 KISALTMALAR:<\/strong><\/h2>

6.1 Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP):<\/strong> Standart \u0130\u015fletme Prosed\u00fcr\u00fc.<\/p>

6.2 Kalite G\u00fcvencesi:<\/strong> Kalite G\u00fcvencesi.<\/p>

6,3 ba\u011f\u0131l nem:<\/strong> Ba\u011f\u0131l Nem.<\/p>

6.4 HVAC:<\/strong> Is\u0131tma, Havaland\u0131rma ve Klima.<\/p>

6.5 BMS:<\/strong> Bina Y\u00f6netim Sistemi.<\/p>

6.6 GMP:<\/strong> \u0130yi \u00dcretim Uygulamalar\u0131.<\/p>

6.7 ICH:<\/strong> Uluslararas\u0131 Uyum Konseyi.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Standard operating procedure of Temperature and Humidity Monitoring in the Pharmaceutical Industry. 1.0 OBJECTIVE: To define the procedure for routine […]<\/p>\n","protected":false},"author":1,"featured_media":18013,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[61],"tags":[],"class_list":["post-17992","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/17992","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/comments?post=17992"}],"version-history":[{"count":0,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/17992\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/18013"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=17992"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=17992"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=17992"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}