المدونات المرجعية

المدونة جهة الإصدار تاريخ الإصدار بشــأن

TRS 1025 Annex 8

Points to consider for setting the remaining shelf-life of medical products upon delivery

منظمة الصحة العالمية 2020 Points to consider for setting the remaining shelf-life of medical products upon delivery

TRS 1025 Annex 7

WHO Technical Report Series, no. 1025: Good storage and distribution practices for medical products

منظمة الصحة العالمية 2020 اشتراطات التخزين والتوزيع الجيد

TRS 1025 - Annex 5

Quality management system requirements for national inspectorates

منظمة الصحة العالمية 2020 Quality management system requirements for national inspectorates

TRS 1010 - Annex 10

WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products 

منظمة الصحة العالمية 2018 These guidelines apply to new and existing APIs and address information to be submitted in original and subsequent applications for marketing authorization of their related FPP for human use

TRS 1011 Annex 3

WHO Technical Report Series, no. 1011: Guidelines on procedures and data requirements for changes to approved biotherapeutic products

منظمة الصحة العالمية 2018 دليل إجراءات ومتطلبات المتغيرات على  المستحضرات الحيوية المسجلة

TRS 1010 - Annex 9

WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions

منظمة الصحة العالمية 2018 WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions

TRS 1010 Annex 2

WHO good manufacturing practices for the manufacture of herbal medicines

منظمة الصحة العالمية 2018

WHO good manufacturing practices for the manufacture of herbal medicines

TRS 1010 Annex1

WHO good manufacturing practices for the manufacture of herbal medicines

منظمة الصحة العالمية 2018

WHO good manufacturing practices for the manufacture of herbal medicines

TRS 996 - Annex 4

WHO guidance on good manufacturing practices: Model inspection report

منظمة الصحة العالمية 2016

WHO guidance on good manufacturing practices: Model inspection report

TRS 993 Annex 4

WHO Technical Report Series, no. 993: Guidelines on procedures and data requirements for changes to approved vaccines

منظمة الصحة العالمية 2015 دليل إجراءات ومتطلبات المتغيرات على اللقاحات المسجلة

TRS 992 - Annex 4 

General guidance on hold-time studies

 

منظمة الصحة العالمية 2015 General guidance on hold-time studies

TRS 992 Annex 5

Technical supplements to Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products

منظمة الصحة العالمية 2015 Technical supplements to Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products

TRS 992 Annex 9

WHO Technical Report Series, no. 992: TRS 992 Annex 9 Good review practices: guidelines for national and regional regulatory authorities

منظمة الصحة العالمية 2015  دليل ممارسات المراجعة الجيدة

TRS 986 Annex2

WHO good manufacturing practices for pharmaceutical products: Main principles

منظمة الصحة العالمية 2014 WHO good manufacturing practices for pharmaceutical products: Main principles

TRS 961 - Annex 14

WHO guidelines for drafting a site master file

 

منظمة الصحة العالمية 2011 WHO guidelines for drafting a site master file

TRS 961 Annex9

Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products

منظمة الصحة العالمية 2011

Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products

TRS 961 Annex 6

WHO good manufacturing practices for sterile pharmaceutical products

منظمة الصحة العالمية 2011 WHO good manufacturing practices for sterile pharmaceutical products

TRS 957 - Annex 2

WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)

منظمة الصحة العالمية 2010 WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)

TRS 957 Annex 3

WHO good manufacturing practices for pharmaceutical products containing hazardous substances

منظمة الصحة العالمية 2010 WHO good manufacturing practices for pharmaceutical products containing hazardous substances

TRS 885 Annex5

WHO good manufacturing practices for the manufacture of pharmaceutical excipients

منظمة الصحة العالمية 1999 WHO good manufacturing practices for the manufacture of pharmaceutical excipients

WHO – guideline for safe disposal of unwanted pharmaceutical 

منظمة الصحة العالمية 1999

مدونة منظمة الصحة العالمية لطرق الاعدام الآمن الخاصة بالمستحضرات الصيدلية

TRS 823 - Annex 2

Inspection of pharmaceutical manufacturers

منظمة الصحة العالمية 1992

Inspection of pharmaceutical manufacturers

WHO- management of waste from immunization campaign activities guideline

منظمة الصحة العالمية 2004

مدونة منظمة الصحة العالمية بشأن كيفية إدارة المخلفات الناتجة عن حملات التطعيم

TRS 902 - Annex 7

WHO guidelines on pre-approval inspections

 

منظمة الصحة العالمية 2002

WHO guidelines on pre-approval inspections

الدليل الإرشادى الخاص بوزارة البيئة بشأن إدارة نفايات الرعاية الصحية فى مصر. وزارة البيئة المصرية 2015 إدارة نفايات الرعاية الصحية فى مصر

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