دوره 2، شماره 1 و 2 - ( 2-1394 )                   جلد 2 شماره 1 و 2 صفحات 44-38 | برگشت به فهرست نسخه ها


XML English Abstract Print


Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:

Kaghazian H, Doroud D. Overview of the validation procedures for a vaccine production: from R&D level to the pre-qualification stage. vacres 2015; 2 (1 and 2) :38-44
URL: http://vacres.pasteur.ac.ir/article-1-62-fa.html
Overview of the validation procedures for a vaccine production: from R&D level to the pre-qualification stage. Vaccine Research. 1394; 2 (1 و 2) :38-44

URL: http://vacres.pasteur.ac.ir/article-1-62-fa.html


چکیده:   (8304 مشاهده)

Just like any other process, vaccine manufacturing procedures are defined as a series of interrelated functions and activities using a variety of specified actions and equipment designed to produce a defined product. To assure the reproducibility and consistency of such processes, they must be carried out using validated equipment and under the established procedures that meet all the acceptance criteria, at least 3 times. In many cases, “worst case” conditions are used for the validation purposes to ensure that the process would be acceptable in extreme cases. Therefore, the validation concept in vaccine production facilities is a key element of the quality assurance goals which may reduce the dependence upon intensive in-process and finished products testing. Nevertheless, the concept of validation has expanded through the years to embrace a wide range of activities such as analytical methods used for quality control of drugs, the computerized systems for the clinical trials, the labeling and the process control. To perform such validation activities properly, the updated knowledge of the current regulations are needed. Therefore, the present article focuses on the recommendations in the related guidelines addressing different aspects of validation procedures related to the vaccine production facilities as a part of the product’s life-cycle.

متن کامل [PDF 341 kb]   (6746 دریافت)    
نوع مطالعه: Review article |
دریافت: 1394/10/15

ارسال نظر درباره این مقاله : نام کاربری یا پست الکترونیک شما:
CAPTCHA

نظرات کاربران
نظر ارسال شده توسط ??? ?? ??? ????????? در تاریخ 1398/5/20
Buy tadalafil india pills <a href="http://cialisndbrx.com/#">buy cialis online</a> cialis generic online <a href="http://cialischmrx.com/#">buy cheap cialis online</a> cialis tablets vega <a href="http://cialischbrx.com/#">buy generic cialis online</a> cialis prescription online <a href="http://cialisdbrx.com/#">buy cheap cialis online</a> viagra youtube <a href="http://chviagranrxusa.com/#">buy generic viagra online</a>

بازنشر اطلاعات
Creative Commons License این مقاله تحت شرایط Creative Commons Attribution-NonCommercial 4.0 International License قابل بازنشر است.

کلیه حقوق این وب سایت متعلق به Vaccine Research می باشد.

طراحی و برنامه نویسی : یکتاوب افزار شرق

© 2024 All Rights Reserved | Vaccine Research

Designed & Developed by : Yektaweb

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.