Quality by design (QbD) for pharmaceutical area

Buket Aksu1, BURCU MESUT2

Makale detayları

Quality by design (QbD) for pharmaceutical area

Yazarlar:

Buket Aksu1, BURCU MESUT2

Yayıncı:

Istanbul University

Dergi:

Journal of Faculty of Pharmacy of Istanbul University 2015 Vol.45 Issue 2, pp.233-251

Belge Tipi:

Makale

Yayın Tarihi:

11/2016

Belge Dili:

Türkçe

Document ID (Org No.):

2000513148

Sıklık:

Aylık

eISSN:

2587-2087

Özet:

 


Abstract: Recent changes and limited resources for drug development and manufacturing have rendered the conventional pharmaceutical quality assurance approach insufficient and have given rise to new research in these areas. To address these research efforts, the FDA improved and modernized the rules governing pharmaceutical manufacturing and product quality in 2002, thereby realizing a paradigm change in the current Good Manufacturing Practices (cGMP). The Quality by Design (QbD) approach has entered the pharmaceutical industry within the last 10 years after the approval of the ICH Q8 in 2005. QbD is based on an understanding of the target product’s quality profile (QTPP) and an assessment of its risks during the design and development of pharmaceutical dosage forms. By determining the critical quality attributes of the drug, including its active ingredient, its excipients, and the processes and design spaces used during the R&D phase, multi-way tracking during the life cycle of the drug can be achieved. This tracking can provide numerous advantages, including flexibility in licensing by decreasing the variation and type modifications in applications of the pharmaceutical product, which result from minimizing the possible issues arising after the release of the product. When all these data are observed, it is clear that the new QbD approach benefits the authorities, the drug manufacturers and the patient. Although QbD has certain challenges during its early stages, it is thought that QbD will benefit pharmaceutical manufacturers.Keywords: Quality by design (QbD), target product quality profile, critical quality attributes, design space, risk assessment.

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Makale detayları

Quality by design (QbD) for pharmaceutical area

Yazarlar: Buket Aksu1, BURCU MESUT2

Yayıncı: Istanbul University

Dergi: Journal of Faculty of Pharmacy of Istanbul University 2015 Vol.45 Issue 2, pp.233-251

Belge Tipi: Makale

Yayın Tarihi: 11/2016

Belge Dili: Türkçe

Document ID (Org No.): 2000513148

Sıklık: Aylık

eISSN: 2587-2087

Sayı

Yazarlar:

Buket Aksu1, BURCU MESUT2

Yayıncı:

Istanbul University

Dergi:

Journal of Faculty of Pharmacy of Istanbul University 2015 Vol.45 Issue 2, pp.233-251

Belge Tipi:

Makale

Yayın Tarihi:

11/2016

Belge Dili:

Türkçe

Document ID (Org No.):

2000513148

Sıklık:

Aylık

eISSN:

2587-2087