Reengineering Pharmaceutical Quality Processes: A Case Study—Labeling
RG Kieffer, ME Diaz - PDA Journal of Pharmaceutical Science and …, 1997 - journal.pda.org
Reengineering Pharmaceutical Quality Processes: A Case Study—Labeling | PDA Journal of
Pharmaceutical Science and Technology Skip to main content Main menu Home Content …
Pharmaceutical Science and Technology Skip to main content Main menu Home Content …
[PDF][PDF] Moving from quality control to quality assurance
G Wingate - Pharm Eng, 2014 - ispe.gr.jp
Conference on 13-14 January 2014 by Dr. Guy Wingate, VP and Compliance Officer (Global
Manufacturing and Supply), GSK. As reflected in the theme of the conference, a collective …
Manufacturing and Supply), GSK. As reflected in the theme of the conference, a collective …
Creating and managing a quality management system
ER Arling, ME Dowling, PA Frankel - … Handbook: Regulations and …, 2008 - books.google.com
Establishing Quality Management System Scope 3.3. 4.1 Defining Business Requirements
3.3. 4.2 Integrating Quality Management System into Quality Plans 3.3. 4.3 Determining …
3.3. 4.2 Integrating Quality Management System into Quality Plans 3.3. 4.3 Determining …
Operational excellence in pharmaceutical quality control labs: driver of an effective quality system
Abstract Purpose Scholars often associate Operational Excellence (OPEX) enablers with
high operational performance. Several studies have concluded that advancing OPEX …
high operational performance. Several studies have concluded that advancing OPEX …
Quality by design and process analytical technology: important tools for buliding quality in pharmaceutical products
A Sunil, G Anju, V Rajat - Biomedical Journal of Scientific & …, 2018 - econpapers.repec.org
EconPapers: Quality by Design and Process Analytical Technology: Important Tools for
Buliding Quality in Pharmaceutical Products EconPapers Economics at your fingertips …
Buliding Quality in Pharmaceutical Products EconPapers Economics at your fingertips …
[HTML][HTML] The metrics of quality culture
A Harrison, S Schniepp - Pharmaceutical Technology, 2015 - pharmtech.com
The long awaited, anxiously anticipated FDA guidance on quality metrics was finally
distributed for comment on July 28, 2015. The official title of this guidance for industry is …
distributed for comment on July 28, 2015. The official title of this guidance for industry is …
[BOOK][B] Process chemistry in the pharmaceutical industry, volume 2: challenges in an ever changing climate
K Gadamasetti, T Braish - 2007 - taylorfrancis.com
As pharmaceutical companies strive to develop safer medicines at a lower cost, they must
keep pace with the rapid growth of technology and research methodologies. Defying the …
keep pace with the rapid growth of technology and research methodologies. Defying the …
Pharmaceutical Manufacturing Validation Principles
EB Souto, T Vasconcelos, DC Ferreira… - Pharmaceutical …, 2010 - Wiley Online Library
The pharmaceutical industry has been a leader in the development of quality and safety
procedures assuring that the risk of its work is reduced to a minimum. Validation is an …
procedures assuring that the risk of its work is reduced to a minimum. Validation is an …
[HTML][HTML] Quality Systems Key to Lifecycle Drug Management
J Wechsler - BioPharm International, 2015 - processdevelopmentforum.com
The submission and review of manufacturing supplements is costly and time consuming for
biopharmaceutical companies and for regulatory authorities in all regions, and a concerted …
biopharmaceutical companies and for regulatory authorities in all regions, and a concerted …
[PDF][PDF] Scale-up & technology transfer as a part of pharmaceutical quality systems
GP Millili - Pharmaceutical Quality System (ICH Q10) …, 2011 - gipslms.goel.edu.in
➢ Is a valuable step in the developmental life cycle leading to successful commercial
manufacturing➢ To take all the gathered knowledge and use it as the basis for the …
manufacturing➢ To take all the gathered knowledge and use it as the basis for the …