Cleaning validation in production area – development of analytical method for quantitative determination of Cefixime residues

Author:

Manasova Miona1,Bilbilovska Elena1,Markoska Janevski Biljana1,Acevska Jelena2,Mitrovska Gordana1,Babunovska Hristina1

Affiliation:

1. Alkaloid AD Skopje, Blvd.Aleksandar Makedonski 12, 1000 Skopje, North Macedonia

2. Faculty of Pharmacy, Ss. Cyril and Methodius University, Mother Teresa 47, 1000 Skopje, North Macedonia

Publisher

Macedonian Pharmaceutical Association

Subject

General Medicine

Reference5 articles.

1. Kaiser, H.J., Ritts, B., 2004. Validation of Analytical Methods Used in Cleaning Validation. Analytical Methods Validation 15-30. Available at: https://asset-pdf.scinapse.io/prod/2526683963/2526683963.pdf

2. International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2005. Validation of Analytical Procedures: Text and Methodology, Q2 (R1).

3. ISPE Guide: Cleaning validation lifecycle - Applications, Methods and Controls, 2020, 99-135.

4. Yang, P., Burson, K., Feder D., Macdonald, F., 2005. Method Development of Swab Sampling for Cleaning Validation of a Residual Active Pharmaceutical Ingredient. Pharmaceutical Technology 29(1), 84-94.

5. Govind, R.P., Kant, A.R.K., Tanuj, J., Dheeraj, B., 2018. A Review On Cleaning Validation In Pharmaceutical Industry. Jorunal of Drug Delivery and Therapeutics 8(3), 138-146. https://doi.org/10.22270/jddt.v8i3.1695

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