Understanding quality by design in the production of pharmaceuticals
DOI:
https://doi.org/10.35954/SM2015.34.1.2Keywords:
Quality Control; Drug Formulation/Methods; Pharmaceutical Products; Drug Release Systems/MethodsAbstract
The concept of Quality by Design (QoD) holds that quality should be designed into the product and that most quality-related problems are due to the way it was designed. The U.S. Food and Drug Administration (FDA) promotes risk-based approaches and the adoption of ObD principles in product development, production and regulation. It recognizes that increased controls do not necessarily improve product quality and that quality must be built into the product.
ObD has evolved with the successive issues of ICH 08 (R2), pharmaceutical development, ICH 09, quality risk management and ICH 010, pharmaceutical quality system. Also other documents issued by ICH contain the parallel assessments of FDA and EMA regarding the elements of ObD in marketing applications and provide guidelines regarding the scope and definitions of ObD as applied to the Pharmaceutical Industry. However, many implementation details are not discussed in the guidance and documents so confusion exists among industry scientists, academics and regulators. This paper will attempt to describe in detail the objectives, concept and implementation of pharmaceutical ObD tools.
Received for evaluation: January 2015.
Accepted for publication: May 2015.
Correspondence: 8 de Octubre 3050 C.P. 11600 Montevideo, Uruguay. Tel: (+598)24876666 int. 1669.
Contact e-mail: qfgabrielanavarro@gmail.com
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