scholarly journals Pharmaceutical Quality/CMC Test Category Terminology

2020 ◽  
Author(s):  
Keyword(s):  
Pharmaceutical Quality ◽  
Test Category

Pharmaceutical quality of yarrow (Achillea millefolium L. s.l.) – Investigation of 40 commercial drug samples by means of the bioactive compounds

Planta Medica ◽  
2007 ◽  
Vol 73 (09) ◽  
Author(s):  
B Benedek ◽  
K Rothwangl-Wiltschnigg ◽  
E Rozema ◽  
N Gjoncaj ◽  
G Reznicek ◽  
...  
Keyword(s):  
Bioactive Compounds ◽  
Achillea Millefolium ◽  
Pharmaceutical Quality

System errors of manufacturers of medicines detected by conducting of state control in the area of circulation of medicines

2019 ◽  
Vol 2019 (5) ◽  
pp. 32-38
Author(s):  
Валентина Косенко ◽  
Valentina Kosenko ◽  
Алла Трапкова ◽  
Alla Trapkova ◽  
Светлана Тарасова ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Management Systems ◽  
State Control ◽  
Quality Management Systems ◽  
Conducting State ◽  
Pharmaceutical Quality ◽  
State Quality ◽  
System Errors

The article conducts the analysis of system errors detected by Roszdravnadzor by conducting state quality control of circulating medicines, as well as weaknesses in pharmaceutical quality management systems of the manufacturers, that can influence the quality of manufactured drugs.

scholarly journals Conformational stability as a quality attribute for the cell therapy raw material human serum albumin

RSC Advances ◽  
2021 ◽  
Vol 11 (25) ◽  
pp. 15332-15339
Author(s):  
Evelien Wynendaele ◽  
Gamaliel Junren Ma ◽  
Xiaolong Xu ◽  
Nam-Joon Cho ◽  
Bart De Spiegeleer
Keyword(s):  
Human Serum Albumin ◽  
Cell Therapy ◽  
Serum Albumin ◽  
Human Serum ◽  
Conformational Stability ◽  
Raw Material ◽  
Quality Attribute ◽  
Global Measure ◽  
Pharmaceutical Quality

An overall attribute for the consistency in pharmaceutical quality of human serum albumin encompasses a global measure of conformational stability, as measured by CD, DLS, QCM-D or LSPR.

Assessing the impact of automation in pharmaceutical quality control labs using a digital twin

2022 ◽  
Vol 62 ◽  
pp. 270-285
Author(s):  
Tiago Coito ◽  
Miguel S.E. Martins ◽  
Bernardo Firme ◽  
João Figueiredo ◽  
Susana M. Vieira ◽  
...  
Keyword(s):  
Quality Control ◽  
Digital Twin ◽  
Pharmaceutical Quality ◽  
The Impact

Risk Management: How Not To Do It

2021 ◽  
Vol 27 (4) ◽  
Author(s):  
Siegfried Schmitt
Keyword(s):  
Risk Management ◽  
Best Practices ◽  
Quality System ◽  
Pharmaceutical Quality ◽  
Pharmaceutical Quality System

Regulations worldwide tell us that a Pharmaceutical Quality System has to be risk-based. In reviewing best practices and ICH Q9 guidelines on QRM, the author shares insights on what not to do, using examples the author has come across over the more than 30 years in industry.

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