Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes

İrem Çelik; Erdem Ceylan; Gülin Akça; Dilek Özer

EN

Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes

Abstract

According to the Good Manufacturing Practices (GMP) guideline, it is mandatory to test for compliance in terms of quality control of every material that are either contained in, or has direct contact with the products manufactured and used in Pharmaceutical Industry. Especially, the materials must be tested microbiologically by using multiple methods according to the guidelines of European Pharmacopeia (EP). For this purpose, it is aimed to determine the compliance of the chosen test and the validation methods related to the structure of the product and their microbiological limits.

Keywords

biocidal products

Ayrıntılar

Birincil Dil

İngilizce

Konular

-

Bölüm

-

Yazarlar

İrem Çelik Bu kişi benim

Erdem Ceylan Bu kişi benim

Gülin Akça Bu kişi benim

Dilek Özer Bu kişi benim

Yayımlanma Tarihi

7 Ocak 2016

Gönderilme Tarihi

6 Ocak 2016

Kabul Tarihi

-

Yayımlandığı Sayı

Yıl 2015 Cilt: 1 Sayı: 2 (2)

IZ

https://izlik.org/JA84AZ72UJ

Kaynak Göster

RIS / Bibtex

APA

Çelik, İ., Ceylan, E., Akça, G., & Özer, D. (2016). Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes. The Turkish Journal Of Occupational / Environmental Medicine and Safety, 1(2 (2). https://izlik.org/JA84AZ72UJ

AMA

1.Çelik İ, Ceylan E, Akça G, Özer D. Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes. turjoem. 2016;1(2 (2). https://izlik.org/JA84AZ72UJ

Chicago

Çelik, İrem, Erdem Ceylan, Gülin Akça, ve Dilek Özer. 2016. “Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes”. The Turkish Journal Of Occupational / Environmental Medicine and Safety 1 (2 (2). https://izlik.org/JA84AZ72UJ.

EndNote

Çelik İ, Ceylan E, Akça G, Özer D (01 Ocak 2016) Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes. The Turkish Journal Of Occupational / Environmental Medicine and Safety 1 2 (2)

IEEE

[1]İ. Çelik, E. Ceylan, G. Akça, ve D. Özer, “Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes”, turjoem, c. 1, sy 2 (2), Oca. 2016, [çevrimiçi]. Erişim adresi: https://izlik.org/JA84AZ72UJ

ISNAD

Çelik, İrem - Ceylan, Erdem - Akça, Gülin - Özer, Dilek. “Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes”. The Turkish Journal Of Occupational / Environmental Medicine and Safety 1/2 (2) (01 Ocak 2016). https://izlik.org/JA84AZ72UJ.

JAMA

1.Çelik İ, Ceylan E, Akça G, Özer D. Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes. turjoem. 2016;1. Available at https://izlik.org/JA84AZ72UJ.

MLA

Çelik, İrem, vd. “Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes”. The Turkish Journal Of Occupational / Environmental Medicine and Safety, c. 1, sy 2 (2), Ocak 2016, https://izlik.org/JA84AZ72UJ.

Vancouver

1.İrem Çelik, Erdem Ceylan, Gülin Akça, Dilek Özer. Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes. turjoem [Internet]. 01 Ocak 2016;1(2 (2). Erişim adresi: https://izlik.org/JA84AZ72UJ