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- Title
New Quality Concepts in Pharmaceuticals.
- Authors
Aksu, Buket; Yegen, Gizem
- Abstract
During the recent years, the pharmaceutical industry, trying to adapt itself to innovations by leaps and bounds, has experienced major developments in production information, quality management systems and risk management, and has developed modern production tools that can assist in ensuring the production quality. These new tools help the manufacturers identify, analyze, correct and prevent problems, and constantly enhance the production processes. Therefore, in 2002, the Food and Drug Administration (FDA) introduced to the drug pharmaceutical industry the amendments in the current Good Manufacturing Practices (cGMP) to improve and modernize the rules that regulate the pharmaceutical product manufacturing and the pharmaceutical product quality. International Conference on Harmonization (ICH) is a forum that gathers the authorities and experts of the pharmaceutical industry in the USA, Japan and Europe to harmonize the technical requirements for pharmaceutical products in these three regions, published current guidelines (ICH Q8, Q9, Q10 and Q11) to bring a new approach which called Quality by Design (QbD) to the industry. As a result of using the new approach of providing quality by design rather than testing it, quality increase, cost reduction and faster market access have been achieved in manufactured products. Moreover, patient safety is emphasized and quicker access to pharmaceutical products by the patient is ensured with a higher quality products.
- Publication
Journal of Marmara University Institute of Health Sciences, 2014, Vol 4, Issue 2, p96
- ISSN
2146-3654
- Publication type
Academic Journal
- DOI
10.5455/musbed.20140327095117