Overview of the validation procedures for a vaccine production: from R&D level to the pre-qualification stage

Q: How can I download an article?

To download an article from SID, first log in to the site, search for the article title, and click on the 'Download Article' option.

Q: How can I download an ISI article?

To download an ISI article on SID, enter the keyword or article title in the search bar, view the relevant results, click on the desired article, and select the 'Download Article' option.

Q: How can I access the SID database?

To access the SID database, visit SID.ir, create an account, and log in to access scientific resources.

Q: Is downloading articles from SID free?

Some articles on SID are available for free, while others require payment. Details are specified on the article's page.

KAGHAZIAN H.; Doroud D.

مرکز اطلاعات علمی Scientific Information Database (SID) - Trusted Source for Research and Academic Resources

Journal Paper

Paper Information

Journal: VACCINE RESEARCH Year:2015 | Volume:2 | Issue:1-2 Page(s): 38-44

Download Full-Text

View:

260

Download:

Cites:

Information Journal Paper

Title

Overview of the validation procedures for a vaccine production: from R&D level to the pre-qualification stage

Author(s)

KAGHAZIAN H. | Doroud D. | Issue Writer Certificate

Keywords

Validation

GMP

Process

Analytical Method

Regulation

Abstract

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.

Cites

No record.

References

No record.

Cite

APA: Copy

KAGHAZIAN, H., & Doroud, D.. (2015). Overview of the validation procedures for a vaccine production: from R&D level to the pre-qualification stage. VACCINE RESEARCH, 2(1-2), 38-44. SID. https://sid.ir/paper/344413/en

Vancouver: Copy

KAGHAZIAN H., Doroud D.. Overview of the validation procedures for a vaccine production: from R&D level to the pre-qualification stage. VACCINE RESEARCH[Internet]. 2015;2(1-2):38-44. Available from: https://sid.ir/paper/344413/en

IEEE: Copy

H. KAGHAZIAN, and D. Doroud, “Overview of the validation procedures for a vaccine production: from R&D level to the pre-qualification stage,” VACCINE RESEARCH, vol. 2, no. 1-2, pp. 38–44, 2015, [Online]. Available: https://sid.ir/paper/344413/en

Related Journal Papers

No record.

Related Seminar Papers

No record.

Related Plans

No record.

Recommended Workshops