RISK ANALYSIS OF THE DEFICIENCIES FOUND BY THE GMP INSPECTIONS
A review of GMP-inspections results and the main found deficiencies was carried out. It was established that in the field of inspection of pharmaceutical companies the unresolved problems with the interpretation of the revealed deficiencies are still, i.e. with the objective (a unified, standardized...
Saved in:
Main Authors: | Yu. V. Podpruznikov, V. N. Shestakov |
---|---|
Format: | Article |
Language: | Russian |
Published: |
LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
|
Series: | Разработка и регистрация лекарственных средств |
Subjects: | |
Online Access: | https://www.pharmjournal.ru/jour/article/view/244 |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Similar Items
-
Evaluation of New Risk-based Regulatory Approach to Classification of GMP Deficiencies (Review)
by: V. N. Shestakov, et al.
Published: (2020-08-01) -
REVIEW, CHARACTERISTICS AND ANALYSIS OF THE LAST CHANGES IN THE GMP REQUIREMENTS
by: Yu. V. Podpruznikov, et al.
Published: (2019-01-01) -
OVERVIEW OF GMP INSPECTIONS RESULTS OF FOREIGN MANUFACTURING SITES IN 2017
by: V. A. Orlov
Published: (2019-01-01) -
Procedure for Reviewing Pharmaceutical Inspections in the Eurasian Economic Union (Review)
by: A. P. Meshkovskiy, et al.
Published: (2021-08-01) -
Assessing the Correlation Between GMP Deviations and Potential Quality Defects of Medicinal Products: the Result of the Survey of Qualified Persons
by: V. A. Orlov, et al.
Published: (2020-05-01)