A review article on cleaning validation in pharmaceutical industry
- VernacularTitle:Эмийн үйлдвэрийн цэвэрлэгээний баталгаажилтын тойм
- Author:
Nomindalai B
1
;
Tsetsegmaa S
2
Author Information
1. Monos Pharma LLC
2. Drug Research Institute
- Publication Type:Journal Article
- Keywords:
Cleaning validation;
Good manufacturing practices (GMP);
Critical parameters;
documentation of cleaning validation
- From:
Mongolian Pharmacy and Pharmacology
2022;21(2):27-34
- CountryMongolia
- Language:Mongolian
-
Abstract:
Abstract:In pharmaceutical industry there are some possibilities of contamination and cross contamination because of improper cleaning of equipment, apparatus, processing area or the starting material, this can lead to severe hazards, therefore in pharmaceutical industry we could not afford any contamination as well as cross contamination. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. Prevention of cross contamination is one of the most significant conditions of Good Manufacturing Practices for drugs. This is especially topical for a multipurpose (shared) manufacture where several medicinal products, including drugs of different pharmacotherapeutic groups, are produced using the same facilities (manufacturing areas, workrooms, and equipment). The industry is able to achieve these key goals with the help of implementation of GMP. Therefore, a perfect cleaning method is required for avoiding the possibilities of contamination and cross contamination, for this a validated program is required, this program is known as cleaning validation. “Cleaning validation is documented evidence which assure that cleaning of equipment, piece of equipment or system will obtain pre-determined and acceptable limits”.
- Full text:MPPJ-2022-21(2)-27-34.pdf
