Quality by Design in Pharmaceutical Manufacturing

Dear Colleagues,

Ensuring quality in pharmaceutical manufacturing is essential to producing drug products that meet safety and efficacy standards. The concept of Quality by Design (QbD) offers a comprehensive and systematic approach, integrating quality into every stage of product development and manufacturing from the outset, rather than relying solely on end-product testing. By emphasizing a deeper understanding of the process and identifying critical quality attributes early, QbD enables the control of key variables, ensuring product consistency while minimizing risks to both patients and manufacturers.

As an integrated approach, QbD incorporates analytical tools to design, analyze, and control manufacturing processes throughout the product lifecycle, along with modern methodologies such as modeling and simulation to gain a deeper understanding of the clinical impact of product and process variables.

This Special Issue focuses on exploring the practical application of QbD principles in pharmaceutical manufacturing, highlighting the latest developments and trends in the field. We invite contributions from researchers and industry experts on the implementation of QbD in manufacturing processes, with particular emphasis on studies that demonstrate how QbD enhances process robustness, optimizes product quality, and accelerates the development of new therapeutic solutions. By bridging the gap between scientific research and practical application, this issue aims to showcase how QbD can drive more efficient, sustainable, and patient-centered drug development.

Dr. Livia Deris Prado
Dr. Yousuf Mohammed
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.