{"id":17231,"date":"2026-08-04T00:44:35","date_gmt":"2026-08-04T00:44:35","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17231"},"modified":"2026-05-06T09:02:41","modified_gmt":"2026-05-06T09:02:41","slug":"sop-for-pest-control-in-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-pest-control-in-pharmaceutical-industry\/","title":{"rendered":"\u0130la\u00e7 End\u00fcstrisinde Ha\u015fere Kontrol\u00fc Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"17231\" class=\"elementor elementor-17231\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-656075b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"656075b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78348194\" data-id=\"78348194\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b902b66 product-data-tab elementor-widget elementor-widget-text-editor\" data-id=\"2b902b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u0130la\u00e7 End\u00fcstrisinde Ha\u015fere Kontrol\u00fcne \u0130li\u015fkin Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc.<\/p><figure id=\"attachment_17253\" aria-describedby=\"caption-attachment-17253\" style=\"width: 2000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-17253\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry.jpg\" alt=\"\u0130la\u00e7 End\u00fcstrisinde Ha\u015fere Kontrol\u00fc Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)\" width=\"2000\" height=\"1334\" title=\"\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry.jpg 2000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry-500x334.jpg 500w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry-1000x667.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry-300x200.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry-1024x683.jpg 1024w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry-768x512.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry-1536x1025.jpg 1536w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Pest-Control-in-Pharmaceutical-Industry-18x12.jpg 18w\" sizes=\"(max-width: 2000px) 100vw, 2000px\" \/><figcaption id=\"caption-attachment-17253\" class=\"wp-caption-text\"><em><strong>\u0130la\u00e7 End\u00fcstrisinde Ha\u015fere Kontrol\u00fc Standart \u0130\u015flem Prosed\u00fcr\u00fc.<\/strong><\/em><\/figcaption><\/figure><h2><strong>1.0 AMA\u00c7:<\/strong><\/h2><p>\u0130la\u00e7 fabrikas\u0131 genelinde ha\u015fere \u00f6nleme, tespit ve kontrol prosed\u00fcr\u00fcn\u00fc belirlemek. T\u00fcm bu prosed\u00fcr\u00fcn amac\u0131 basittir: B\u00f6cekleri, kemirgenleri, ku\u015flar\u0131 ve di\u011fer ha\u015fereleri, \u00fcr\u00fcn kalitesini tehlikeye atmadan veya personeli herhangi bir riske maruz b\u0131rakmadan tesisin d\u0131\u015f\u0131na tutmak.<\/p><h2><strong>2.0 KAPSAM:<\/strong><\/h2><p>Bu Prosed\u00fcr, tesisin tamam\u0131n\u0131 kapsamaktad\u0131r. \u00dcretim bloklar\u0131, depolar, kalite kontrol laboratuvarlar\u0131, hizmet alanlar\u0131, kantin, tuvaletler ve s\u0131n\u0131r duvar\u0131na kadar uzanan d\u0131\u015f \u00e7evre alan\u0131 bu kapsamdad\u0131r.<\/p><h2><strong>3.0 SORUMLULUK:<\/strong><\/h2><p>Temizlik Sorumlusu, D\u0131\u015f Ha\u015fere Kontrol Firmas\u0131 ve Kalite G\u00fcvence Sorumlusu.<\/p><h2><strong>4.0 SORUMLULUK:<\/strong><\/h2><p>Fabrika M\u00fcd\u00fcr\u00fc ve Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc.<\/p><h2><strong>5.0 \u0130\u015eLEM:<\/strong><\/h2><p>5.1 Tesisdeki ha\u015fere kontrol \u00e7al\u0131\u015fmalar\u0131, harici bir kurulu\u015fla yap\u0131lan resmi bir yaz\u0131l\u0131 s\u00f6zle\u015fme kapsam\u0131nda y\u00fcr\u00fct\u00fclmektedir. \u0130\u015fin kapsam\u0131, ziyaret s\u0131kl\u0131\u011f\u0131, kullan\u0131lan kimyasallar ve tutulmas\u0131 gereken t\u00fcm hizmet kay\u0131tlar\u0131 bu s\u00f6zle\u015fmede ayr\u0131nt\u0131l\u0131 olarak belirtilmi\u015ftir.<\/p><p>5.2 Genel Ha\u015fere Kontrol Program\u0131, Temizlik Sorumlusu\u2019nun dosyas\u0131nda bulunmaktad\u0131r. Programda, tesisin her bir alan\u0131 i\u00e7in o alana atanan m\u00fcdahale t\u00fcr\u00fc ve s\u0131kl\u0131\u011f\u0131 belirtilmi\u015ftir.<\/p><p>5.3 Her ha\u015fere kontrol\u00fc ziyareti, \u00f6nceden Kalite G\u00fcvencesi (QA) birimine bildirilmelidir. \u00dcretim veya depo alanlar\u0131na \u00f6nceden haber verilmeden yap\u0131lacak ziyaretler, giri\u015f kap\u0131s\u0131ndan ge\u00e7irilmeyecektir.<\/p><p>5.4 \u00dcr\u00fcnle temas eden bir alanda herhangi bir ha\u015fere kontrol \u00e7al\u0131\u015fmas\u0131 ba\u015flamadan \u00f6nce, Kalite G\u00fcvencesi (QA) biriminden bir \u201cHat Bo\u015faltma Onay\u0131\u201d al\u0131n\u0131r. Bu onay, \u00fcr\u00fcnlerin ve a\u00e7\u0131k ambalajlar\u0131n alan d\u0131\u015f\u0131na \u00e7\u0131kar\u0131ld\u0131\u011f\u0131 veya \u00fczerlerinin kapat\u0131ld\u0131\u011f\u0131na dair teyittir.<\/p><h3><strong>5.5 Hedef Zararl\u0131lar ve Risk:<\/strong><\/h3><p>5.5.1 Bir ila\u00e7 fabrikas\u0131nda \u00e7e\u015fitli zararl\u0131 t\u00fcrleri kontrol alt\u0131nda tutulmal\u0131d\u0131r. Her t\u00fcr, \u00fcr\u00fcn ve personel i\u00e7in kendine \u00f6zg\u00fc riskler bar\u0131nd\u0131r\u0131r.<\/p><p>5.5.2 Ba\u015fl\u0131ca hedef zararl\u0131lar ve her biriyle ili\u015fkili riskler a\u015fa\u011f\u0131da belirtilmi\u015ftir:<\/p><p>5.5.2.1 Kemirgenler (s\u0131\u00e7anlar ve fareler): hammaddeleri kirletir, ambalajlar\u0131 ve elektrik kablolar\u0131n\u0131 kemirerek deler ve ciddi zoonotik hastal\u0131klar ta\u015f\u0131r.<\/p><p>5.5.2.2 U\u00e7an b\u00f6cekler (sinekler, g\u00fcveler, sivrisinekler): V\u00fccutlar\u0131na bakteri bula\u015ft\u0131r\u0131r ve s\u0131cak depolanan malzemelerin i\u00e7ine yumurta b\u0131rak\u0131rlar.<\/p><p>5.5.2.3 S\u00fcr\u00fcnerek hareket eden b\u00f6cekler (hamamb\u00f6cekleri, kar\u0131ncalar, g\u00fcm\u00fc\u015fb\u00f6cekleri): Y\u00fczeylerde d\u0131\u015fk\u0131 ve deri kal\u0131nt\u0131lar\u0131 b\u0131rak\u0131r ve makinelerin \u00e7evresindeki s\u0131cak ve karanl\u0131k alanlarda saklan\u0131rlar.<\/p><p>5.5.2.4 Depolanan \u00fcr\u00fcn zararl\u0131lar\u0131 (b\u00f6cekler, k\u0131nkanatl\u0131lar, akarlar): depoda bulunan yard\u0131mc\u0131 maddeler ve ambalaj malzemeleri gibi kuru \u00fcr\u00fcnlere girerler.<\/p><p>5.5.2.5 Ku\u015flar (g\u00fcvercinler ve ser\u00e7eler): \u00c7at\u0131lar\u0131n \u00fczerinde ve y\u00fckleme rampalar\u0131n\u0131n \u00e7evresinde yuva yaparlar. D\u0131\u015fk\u0131lar\u0131 olduk\u00e7a asidiktir ve mantar sporlar\u0131 i\u00e7erir.<\/p><p>5.5.2.6 Sahipsiz hayvanlar (kediler, k\u00f6pekler): \u00c7evre duvarlar\u0131ndaki bo\u015fluklardan i\u00e7eri s\u0131zarak tesise t\u00fcy, parazit ve kir getirirler.<\/p><p>5.5.3 \u00dcretim veya depolama alan\u0131nda herhangi bir zararl\u0131 g\u00f6r\u00fclmesi durumunda, bu durum Zararl\u0131 G\u00f6r\u00fclme Kay\u0131t Defteri\u2019ne kaydedilir ve Kalite G\u00fcvencesi\u2019ne bildirilir. Do\u011frulanm\u0131\u015f bir istila durumunda ise, bu s\u00fcre\u00e7 bir ad\u0131m daha ileri gider ve g\u00f6r\u00fclme an\u0131ndan itibaren iki saat i\u00e7inde Kalite G\u00fcvencesi\u2019ne uyar\u0131da bulunulmas\u0131 gerekir.<\/p><h3><strong>5.6 \u00d6nleyici Tedbirler:<\/strong><\/h3><p>5.6.1 \u00d6nleme, tedaviden her zaman daha etkilidir. Tesis, kimyasallara a\u015f\u0131r\u0131 ba\u011f\u0131ml\u0131 kalmadan zararl\u0131 b\u00f6cek say\u0131s\u0131n\u0131 d\u00fc\u015f\u00fck tutmak i\u00e7in entegre zararl\u0131 b\u00f6cek y\u00f6netimi yakla\u015f\u0131m\u0131n\u0131 benimsemektedir.<\/p><p>5.6.2 Zararl\u0131lar\u0131n giri\u015fini engellemeye y\u00f6nelik yap\u0131sal \u00f6nlemler \u015funlard\u0131r:<\/p><p>5.6.2.1 Her t\u00fcrl\u00fc duvar \u00e7atla\u011f\u0131n\u0131, boru giri\u015fini ve kablo deli\u011fini \u00e7imento veya silikonla kapat\u0131n. Bu s\u0131zd\u0131rmazl\u0131k i\u015flemleri alt\u0131 ayda bir yeniden denetlenir.<\/p><p>5.6.2.2 T\u00fcm d\u0131\u015f drenaj kanallar\u0131na, pencerelere ve havaland\u0131rma deliklerine metal has\u0131r \u0131zgaralar tak\u0131n. Bir farenin ge\u00e7mesini engelleyecek kadar k\u00fc\u00e7\u00fck g\u00f6zl\u00fc bir has\u0131r se\u00e7in.<\/p><p>5.6.2.3 \u00dcretim ve depo alanlar\u0131n\u0131n giri\u015f noktalar\u0131na hava perdeleri veya kendili\u011finden kapanan kap\u0131lar tak\u0131lmal\u0131d\u0131r.<\/p><p>5.6.2.4 Y\u00fckleme rampalar\u0131ndaki t\u00fcm y\u00fckleme k\u00f6pr\u00fclerini kontrol edin. Her birinin treylere s\u0131k\u0131ca kapanmas\u0131 gerekir. 6 mm\u2019lik bir bo\u015fluk bile bir farenin i\u00e7eri s\u0131zmas\u0131na yeterlidir.<\/p><p>5.6.3 Zararl\u0131lar\u0131n \u00e7ekilmesini \u00f6nlemeye y\u00f6nelik temizlik \u00f6nlemleri \u015funlard\u0131r:<\/p><p>5.6.3.1 Yemek molas\u0131ndan sonraki bir saat i\u00e7inde kantinden t\u00fcm yemek art\u0131klar\u0131 temizlenmelidir. \u00c7\u00f6p kutusu binan\u0131n d\u0131\u015f\u0131nda tutulmal\u0131d\u0131r.<\/p><p>5.6.3.2 Her vardiya sonunda t\u00fcm \u00e7\u00f6p kutular\u0131n\u0131 bo\u015falt\u0131n. Gece boyunca koridorda b\u0131rak\u0131lan dolu bir \u00e7\u00f6p kutusu, ha\u015fereleri \u00e7eker.<\/p><p>5.6.3.3 Hammaddeleri paletler \u00fczerine istifleyin; zeminden en az 15 cm y\u00fckseklikte ve duvarlardan en az 45 cm uzakta olacak \u015fekilde. Bu bo\u015fluk, her istifin \u00e7evresinde g\u00f6rsel inceleme i\u00e7in bir yol b\u0131rak\u0131r.<\/p><p>5.6.3.4 Her t\u00fcrl\u00fc su s\u0131z\u0131nt\u0131s\u0131n\u0131 24 saat i\u00e7inde giderin. Biriken su, birka\u00e7 g\u00fcn i\u00e7inde sinekleri ve kemirgenleri i\u00e7eriye \u00e7eker.<\/p><p>5.6.3.5 \u00c7itleri ve a\u011fa\u00e7 dallar\u0131n\u0131, bina duvar\u0131ndan en az 1 metre uzakta kalacak \u015fekilde buday\u0131n. A\u015f\u0131r\u0131 b\u00fcy\u00fcm\u00fc\u015f bitkiler, zararl\u0131lar\u0131n \u00e7at\u0131ya kolayca ula\u015fmas\u0131na yol a\u00e7ar.<\/p><h3><strong>5.7 Ha\u015fere Kontrol Cihazlar\u0131:<\/strong><\/h3><h4><strong><b>5.7.1 Elektronik Sinek \u00d6ld\u00fcr\u00fcc\u00fcler (EFK):<\/b><\/strong><\/h4><p>5.7.1.1 EFK\u2019lar her ana giri\u015f noktas\u0131nda ve kantinde yer almaktad\u0131r. Her birim, u\u00e7an b\u00f6cekleri i\u00e7erideki yap\u0131\u015fkan panele \u00e7ekmek i\u00e7in UV \u0131\u015f\u0131\u011f\u0131 kullanmaktad\u0131r.<\/p><p>5.7.1.2 Her bir EFK\u2019yi 2 ila 2,5 metre y\u00fcksekli\u011fe monte edin. \u00dcniteyi d\u0131\u015far\u0131ya, pencereye do\u011fru y\u00f6neltmeyin. D\u0131\u015far\u0131ya bakan bir \u00fcnite, caddeden daha fazla b\u00f6cek \u00e7ekecektir.<\/p><p>5.7.1.3 Yap\u0131\u015fkan levhay\u0131 haftada bir kez de\u011fi\u015ftirin. Kullan\u0131lm\u0131\u015f bir levha, yakalanan ha\u015fere say\u0131s\u0131n\u0131 g\u00f6sterir ve bu say\u0131, b\u00f6lgedeki ha\u015fere faaliyetine ili\u015fkin yararl\u0131 bir g\u00f6stergedir.<\/p><p>5.7.1.4 UV t\u00fcpleri, 12 ayl\u0131k kullan\u0131m\u0131n ard\u0131ndan g\u00fc\u00e7lerini yitirir. T\u00fcpler h\u00e2l\u00e2 yan\u0131yor gibi g\u00f6r\u00fcnseler bile, belirlenen zamanlamaya g\u00f6re de\u011fi\u015ftirin.<\/p><p>5.7.1.5 EFK\u2019yi bir \u00fcr\u00fcn\u00fcn temas y\u00fczeyinin tam \u00fczerine monte etmeyin. Bak\u0131m s\u0131ras\u0131nda \u00fcnite i\u00e7inden \u00f6l\u00fc b\u00f6cekler d\u00fc\u015febilir.<\/p><h4><strong><b>5.7.2 Kemirgen Yem \u0130stasyonlar\u0131:<\/b><\/strong><\/h4><p>5.7.2.1 Yem istasyonlar\u0131, kurcalanmaya kar\u015f\u0131 korumal\u0131 kutulard\u0131r. Her birinin i\u00e7inde kemirgen ilac\u0131 bloklar\u0131 bulunur, kilitli durumdad\u0131r ve \u00fczerinde benzersiz bir kimlik etiketi bulunur.<\/p><p>5.7.2.2 D\u0131\u015f yem istasyonlar\u0131n\u0131 \u00e7evre duvar\u0131 boyunca her 10 ila 15 metrede bir yerle\u015ftirin. Her birini yerinden k\u0131p\u0131rdamayacak \u015fekilde zemine sabitleyin.<\/p><p>5.7.2.3 \u0130la\u00e7 \u00fcretim alanlar\u0131n\u0131n i\u00e7inde kapal\u0131 yem istasyonlar\u0131 kullan\u0131lmaz. Bunun yerine, zehirsiz yap\u0131\u015fkan levhalar veya \u00e7\u0131t\u00e7\u0131tl\u0131 tuzaklar kullan\u0131l\u0131r.<\/p><p>5.7.2.4 Her yem istasyonu, haftal\u0131k ha\u015fere kontrol ziyaretinde denetlenir. Al\u0131nan yemler, yenilenen yemler ve yakalanan kemirgenler kay\u0131t alt\u0131na al\u0131nmal\u0131d\u0131r.<\/p><p>5.7.2.5 Her bir yem istasyonunun konumunu Tesis Zararl\u0131 Haritas\u0131 \u00fczerinde i\u015faretleyin. Herhangi bir istasyonun yeri de\u011fi\u015fti\u011fi anda haritay\u0131 g\u00fcncelleyin.<\/p><h4><strong><b>5.7.3 Yap\u0131\u015fkan Levhalar ve \u00c7\u0131t\u00e7\u0131tl\u0131 Tuzaklar:<\/b><\/strong><\/h4><p>5.7.3.1 Yap\u0131\u015fkan levhalar, kemirgenleri ve s\u00fcr\u00fcnen b\u00f6cekleri yakalamak i\u00e7in toksik olmayan bir y\u00f6ntem olarak depolar\u0131n, koridorlar\u0131n ve hizmet alanlar\u0131n\u0131n i\u00e7inde kullan\u0131l\u0131r. Yap\u0131\u015fkan levhalar, aktif \u00fcretim temiz odalar\u0131n\u0131n i\u00e7ine yerle\u015ftirilmez.<\/p><p>5.7.3.2 Yap\u0131\u015fkan levhalar\u0131 duvarlar boyunca ve makine tabanlar\u0131n\u0131n yak\u0131n\u0131na yerle\u015ftirin. Kemirgenler, a\u00e7\u0131k zemini ge\u00e7mek yerine duvarlar boyunca ko\u015farlar.<\/p><p>5.7.3.3 Yap\u0131\u015fkan levhalar\u0131 her hafta de\u011fi\u015ftirin; e\u011fer bir tanesi halihaz\u0131rda bir ha\u015fere yakalam\u0131\u015fsa, daha erken de\u011fi\u015ftirin. Kullan\u0131lm\u0131\u015f bir levhan\u0131n \u00e7ok uzun s\u00fcre b\u0131rak\u0131lmas\u0131 bakteri yay\u0131lmas\u0131na neden olabilir.<\/p><p>5.7.3.4 \u00c7\u0131t\u00e7\u0131tl\u0131 tuzaklar yaln\u0131zca hizmet alanlar\u0131nda bulundurulur. Her tuza\u011f\u0131 g\u00fcnl\u00fck olarak kontrol edin. Tuzakta b\u0131rak\u0131lan \u00f6l\u00fc bir kemirgen, 24 saat i\u00e7inde \u00e7\u00fcr\u00fcyecek ve sinekleri \u00e7ekecektir.<\/p><p>5.7.3.5 Yakalanan her zararl\u0131y\u0131 \u201cZararl\u0131 Yakalama Kayd\u0131\u201dna kaydedin. Tuzak kimli\u011fini, tarihi, zararl\u0131 t\u00fcr\u00fcn\u00fc ve al\u0131nan \u00f6nlemi not edin.<\/p><h4><strong><b>5.7.4 Feromon Tuzaklar\u0131:<\/b><\/strong><\/h4><p>5.7.4.1 Feromon tuzaklar\u0131, depo i\u00e7indeki b\u00f6cekler ve g\u00fcveler gibi depolanm\u0131\u015f \u00fcr\u00fcn zararl\u0131lar\u0131n\u0131 hedef al\u0131r. Tuzaktaki koku yemi, hedef b\u00f6ce\u011fi yap\u0131\u015fkan bir y\u00fczeye \u00e7eker.<\/p><p>5.7.4.2 Depo zemininin her 100 metrekaresi ba\u015f\u0131na bir adet feromon tuza\u011f\u0131 yerle\u015ftirin. Her tuza\u011f\u0131 1,5 metre y\u00fcksekli\u011fe as\u0131n.<\/p><p>5.7.4.3 Feromon yemlerinin \u00f6mr\u00fc 6 ila 8 haftad\u0131r. Hi\u00e7 av yakalanmam\u0131\u015f olsa bile, yemi zaman\u0131nda de\u011fi\u015ftirin.<\/p><p>5.7.4.4 Bir tuzakta bir av\u0131n yakalanmas\u0131 normal bir durumdur. \u00dc\u00e7 hafta \u00fcst \u00fcste artan av say\u0131s\u0131, m\u00fcdahale gerektiren, b\u00fcy\u00fcmekte olan bir pop\u00fclasyona i\u015faret eder.<\/p><h3><strong>5.8 Kimyasal Ar\u0131tma Kurallar\u0131:<\/strong><\/h3><p>5.8.1 Tesiste kullan\u0131lan her pestisit, ilk kez kullan\u0131ma sunulmadan \u00f6nce Kalite G\u00fcvencesi (QA) birimi taraf\u0131ndan onaylanmal\u0131d\u0131r. Onay, \u00fcr\u00fcn etiketi, g\u00fcvenlik bilgi formu ve tesiste kullan\u0131m\u0131na izin verilen aktif maddelerin listesine dayal\u0131d\u0131r.<\/p><p>5.8.2 \u00dcretim devam ederken, \u00fcr\u00fcnle temas eden alanlarda hi\u00e7bir kimyasal i\u015flem yap\u0131lmas\u0131na izin verilmez. P\u00fcsk\u00fcrtme i\u015flemi, ancak alan bo\u015falt\u0131ld\u0131ktan ve \u00fcr\u00fcnler uygun \u015fekilde \u00f6rt\u00fcld\u00fckten sonra ger\u00e7ekle\u015ftirilir.<\/p><p>5.8.3 Sisleme ve p\u00fcsk\u00fcrtme i\u015flemleri hafta sonlar\u0131 veya planl\u0131 kesintiler s\u0131ras\u0131nda ger\u00e7ekle\u015ftirilir. Tedavi plan\u0131, \u00e7al\u0131\u015fmadan en az 72 saat \u00f6nce kalite g\u00fcvencesi (QA) imzas\u0131 al\u0131r.<\/p><p>5.8.4 Ha\u015fere kontrol \u015firketi, \u015fantiyeye getirdi\u011fi her kimyasal madde i\u00e7in bir g\u00fcvenlik bilgi formunu teslim eder. Bu formlar, Kalite G\u00fcvencesi (QA) birimi taraf\u0131ndan tutulan Kimyasal Kay\u0131t Defteri\u2019nde dosyalan\u0131r.<\/p><p>5.8.5 Herhangi bir kimyasal i\u015flemden sonra, i\u015fleme tabi tutulmu\u015f alan, kimyasal etiketinde belirtilen bekleme s\u00fcresi boyunca kullan\u0131ma kapat\u0131l\u0131r. Tipik bir bekleme s\u00fcresi 4 ila 24 saat aras\u0131ndad\u0131r.<\/p><p>5.8.6 Bekleme s\u00fcresi sona erdi\u011finde, \u00fcr\u00fcnle temas eden alanlardan bir y\u00fczey swab\u0131 al\u0131n\u0131r. Alan\u0131n yeniden \u00fcretim ama\u00e7l\u0131 kullan\u0131ma a\u00e7\u0131lmas\u0131ndan \u00f6nce, swap \u00fczerinde kimyasal kal\u0131nt\u0131 olup olmad\u0131\u011f\u0131 kontrol edilir.<\/p><h3><strong>5.9 Kurum Ziyaret Protokol\u00fc:<\/strong><\/h3><p>5.9.1 D\u0131\u015f ha\u015fere kontrol \u015firketi, tesise haftada bir d\u00fczenli ziyaret ger\u00e7ekle\u015ftirmektedir. Herhangi bir ha\u015fere istilas\u0131 bildirildi\u011finde ek ziyaretler planlanmaktad\u0131r.<\/p><p>5.9.2 Her ziyaret g\u00fcvenlik kap\u0131s\u0131ndan ba\u015flar. Ajans teknisyeni burada giri\u015f kayd\u0131n\u0131 yapar ve ard\u0131ndan Temizlik Sorumlusuna rapor verir.<\/p><p>5.9.3 Her teknisyen, ziyaret s\u00fcresince tesis taraf\u0131ndan sa\u011flanan KKD\u2019yi giymek zorundad\u0131r. Temel KKD, tek kullan\u0131ml\u0131k \u00f6nl\u00fck, eldiven ve sa\u00e7 filtresinden olu\u015fur. Temiz alanlara girerken ayakkab\u0131 k\u0131l\u0131flar\u0131 giyilmelidir.<\/p><p>5.9.4 Tesis personeli, ziyaret s\u00fcresince teknisyene e\u015flik eder. E\u015flik eden personel, kontroll\u00fc alanlar\u0131n kilitlerini a\u00e7ar, i\u015flemlerin ger\u00e7ekle\u015ftirilmesini izler ve sonunda hizmet raporunu imzalar.<\/p><p>5.9.5 Her ziyaretin sonunda, teknisyen bir Ha\u015fere Kontrol Hizmeti Raporu sunar. Raporda, denetlenen alanlar, bak\u0131m\u0131 yap\u0131lan cihazlar, tespit edilen ha\u015fereler ve uygulanan i\u015flemler listelenir.<\/p><p>5.9.6 Kalite G\u00fcvencesi birimi, ziyaretin ard\u0131ndan bir i\u015f g\u00fcn\u00fc i\u00e7inde hizmet raporunu inceler ve imzalar. Dosyalanm\u0131\u015f hizmet raporu, denetimler s\u0131ras\u0131nda GMP kan\u0131t\u0131 olarak kabul edilir.<\/p><h3><strong>5.10 \u0130zleme ve E\u011filim Analizi:<\/strong><\/h3><p>5.10.1 Temizlik Sorumlusu, her denetimden sonra Zararl\u0131 B\u00f6cek Yakalama Kay\u0131t Defteri\u2019ni g\u00fcnceller. Tesis genelinde tespit edilen her zararl\u0131 b\u00f6cek, tarih ve yer bilgileriyle birlikte kay\u0131t defterine i\u015flenir.<\/p><p>5.10.2 Haftal\u0131k yakalama verileri, her zararl\u0131 kategorisi i\u00e7in ayr\u0131 ayr\u0131 birer e\u011filim grafi\u011fine i\u015flenir. Grafik, yakalama say\u0131s\u0131n\u0131n art\u0131p artmad\u0131\u011f\u0131n\u0131, azal\u0131p azalmad\u0131\u011f\u0131n\u0131 veya sabit kal\u0131p kalmad\u0131\u011f\u0131n\u0131 bir bak\u0131\u015fta g\u00f6sterir.<\/p><p>5.10.3 Her zararl\u0131 t\u00fcr\u00fc i\u00e7in bir m\u00fcdahale e\u015fi\u011fi bulunmaktad\u0131r. Bu e\u015fi\u011fin a\u015f\u0131lmas\u0131 durumunda, resmi bir soru\u015fturma ba\u015flat\u0131l\u0131r ve bir d\u00fczeltici eylem plan\u0131 haz\u0131rlan\u0131r.<\/p><p>5.10.4 Ayl\u0131k Zararl\u0131 Raporunda, yakalama verileri, uygulanan m\u00fcdahaleler ve halen devam etmekte olan d\u00fczeltici \u00f6nlemler bir araya getirilmektedir. Kalite G\u00fcvencesi (QA) ekibi, ayl\u0131k GMP toplant\u0131s\u0131nda bu raporu g\u00f6zden ge\u00e7irir.<\/p><p>5.10.5 Herhangi bir zararl\u0131 t\u00fcr\u00fcnde meydana gelen ani art\u0131\u015f, bir sapma olarak de\u011ferlendirilir. Sapma raporu, tesis sapma standart operasyon prosed\u00fcr\u00fc (SOP) kapsam\u0131nda d\u00fczenlenir ve sorunun temel nedeni ara\u015ft\u0131r\u0131l\u0131r.<\/p><h3><strong>5.11 Personel E\u011fitimi:<\/strong><\/h3><p>5.11.1 Her tesis \u00e7al\u0131\u015fan\u0131, \u015firkete kat\u0131ld\u0131\u011f\u0131nda temel ha\u015fere fark\u0131ndal\u0131k e\u011fitimini tamamlar ve bundan sonra her y\u0131l bir kez bu e\u011fitimi tekrar al\u0131r. E\u011fitim, ha\u015ferelerin tan\u0131mlanmas\u0131, bildirilmesi ve her \u00e7al\u0131\u015fan\u0131n \u00fcstlendi\u011fi temizlik g\u00f6revlerini kapsar.<\/p><p>5.11.2 Temizlik personeli, harici yem istasyonlar\u0131n\u0131n denetimi, yap\u0131\u015fkan levhalar\u0131n de\u011fi\u015ftirilmesi ve yakalanan zararl\u0131lar\u0131n g\u00fcvenli bir \u015fekilde bertaraf edilmesi konular\u0131nda ek e\u011fitim al\u0131r.<\/p><p>5.11.3 E\u011fitim, Kalite G\u00fcvencesi (QA) birimi veya ha\u015fere kontrol kurulu\u015fu taraf\u0131ndan d\u00fczenlenir. Kat\u0131l\u0131m durumu, E\u011fitim Kat\u0131l\u0131m Formu\u2019na kaydedilir.<\/p><p>5.11.4 Zararl\u0131 b\u00f6cek g\u00f6ren herhangi bir personel, bunu derhal amirine bildirmesi te\u015fvik edilir. Bu ama\u00e7la her departman\u0131n ilan panosunda bir \u201cZararl\u0131 B\u00f6cek G\u00f6r\u00fcnt\u00fcleme Kayd\u0131\u201d bulunmaktad\u0131r.<\/p><h3><strong>5.12 KAYIT:<\/strong><\/h3><p>5.12.1 Ana Ha\u015fere Kontrol Program\u0131.<\/p><p>5.12.2 Tesis Zararl\u0131 B\u00f6cek Haritas\u0131.<\/p><p>5.12.3 Zararl\u0131 B\u00f6cek Yakalama Kayd\u0131.<\/p><p>5.12.4 Kimyasal Kay\u0131t Defteri.<\/p><p>5.12.5 Ha\u015fere Kontrol Hizmeti Raporu.<\/p><p>5.12.6 Ayl\u0131k Zararl\u0131 B\u00f6cek Raporu.<\/p><p>5.12.7 Zararl\u0131 B\u00f6cek G\u00f6r\u00fcnt\u00fcleme Kayd\u0131.<\/p><p>5.12.8 E\u011fitim Kat\u0131l\u0131m \u00c7izelgesi.<\/p><h2><strong>6.0 KISALTMALAR:<\/strong><\/h2><p><strong>6.1 Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP):<\/strong> Standart \u0130\u015fletme Prosed\u00fcr\u00fc.<\/p><p><strong>6.2 Kalite G\u00fcvencesi:<\/strong> Kalite G\u00fcvencesi.<\/p><p><strong>6.3 Ki\u015fisel Koruyucu Donan\u0131m (KKD):<\/strong> Ki\u015fisel Koruyucu Ekipman.<\/p><p><strong>6.4 EFK:<\/strong> Elektronik Sinek \u00d6ld\u00fcr\u00fcc\u00fc.<\/p><p><strong>6,5 UV:<\/strong> Ultraviyole.<\/p><p><strong>6.6 GMP:<\/strong> \u0130yi \u00dcretim Uygulamalar\u0131.<\/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":"<p>Standard operating procedure of Pest Control in the Pharmaceutical Industry. 1.0 OBJECTIVE: To lay down the procedure for pest prevention, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17253,"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 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