Reliable drug quality: an unresolved problem

J Woodcock - PDA Journal of Pharmaceutical Science and …, 2012 - journal.pda.org
Reliable Drug Quality: An Unresolved Problem | PDA Journal of Pharmaceutical Science and
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[HTML][HTML] The pharmaceutical quality revolution

J Botet - ScienceRise, 2016 - cyberleninka.ru
Pharmaceutical products are patient-oriented. If they had a deficient quality they might put
live at risk. Ensuring their quality is not, however, a straightforward task and this is why …

Quality By Design: Modern Approach In Pharmaceutics For Quality Pharmaceuticals

S Soni, P Sahu, MS Dikkatwar - Journal of Pharmaceutical Negative …, 2023 - pnrjournal.com
The latest approach to pharmaceutical quality is Quality by Design. This article introduces
Pharmaceutical Quality by Design (QbD) and shows how Quality by Design is used to …

Advancing pharmaceutical quality: An overview of science and research in the US FDA's Office of Pharmaceutical Quality

AC Fisher, SL Lee, DP Harris, L Buhse… - International journal of …, 2016 - Elsevier
Failures surrounding pharmaceutical quality, particularly with respect to product
manufacturing issues and facility remediation, account for the majority of drug shortages and …

Meeting report: an exploration into the scientific and regulatory aspects of pharmaceutical drug quality in the United States

BM Flavin, LE Happe, RC Hatton - Expert Opinion on Drug Safety, 2022 - Taylor & Francis
ABSTRACT Introduction The University of Florida College of Pharmacy, Department of
Pharmaceutical Outcomes and Policy hosted a seminar 6–7 March 2021, on the quality of …

Product quality, quality control and validation

R Lange, T Schnor - … Pharmaceutics: An International Guideline for the …, 2023 - Springer
The quality of pharmaceutical preparations is the result of the planning and implementation
of the manufacturing process. The Good Manufacturing Practice (GMP) principles and …

[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 …

[PDF][PDF] The concept of pharmaceutical quality

J Woodcock - American Pharmaceutical Review, 2004 - researchgate.net
During the last several decades, the quality of pharmaceutical products has not been a
matter of much concern to prescribers, pharmacists or consumers in the United States. Tales …

A review on introduction to quality assurance

DK Patil, DR Patil, SA Patil - Research journal of Pharmacology …, 2023 - indianjournals.com
Quality assurance (QA) is the management technique used to provide adequate confidence
that a product, service, or result will satisfy requirements for quality and be fit for use. Each …

Significance of drug substance physicochemical properties in regulatory quality by design

SL Lee, AS Raw, L Yu - Drugs and the pharmaceutical sciences, 2008 - taylorfrancis.com
Due to the growing complexity of drug substances and formulations, developing a quality (1)
drug product and a process that manufactures it in a reproducible manner becomes …