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35th Anniversary Special: Reader Views on Changes in Pharmaceutical Manufacturing
To gain a perspective on what have been the most significant changes affecting pharmaceutical development and manufacturing, Pharmaceutical Technology conducted a series of reader polls between December 2011 and May 2012 that asked our readers what they regarded as the most important changes affecting drug-substance and drug-product development and manufacturing during the past 10 years. The polls were directed in five main areas: small-molecule API manufacturing, biologic-based API manufacturing, solid dosage/oral drug delivery, sterile manufacturing, and analytical methods development and instrumentation (see Figures 1–5). Although individual technological advances were cited, an important theme throughout all the polls was the importance of quality by design (QbD).
The importance of quality by design
QbD came into prominence a decade ago when FDA announced a significant new initiative in August 2002, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (1). The initiative was intended to modernize FDA's regulation of pharmaceutical quality for drugs and select human biological
products such as vaccines. The initiative evaluated the pharmaceutical as well as the chemistry, manufacturing, and controls
(CMC) regulatory programs with the following specific goals:
The science- and risk-based approach to pharmaceutical manufacturing that underpins quality by design has been furthered by subsequent guidance from FDA, EMA, and the International Conference on Harmonization. It is not surprising, therefore, that QbD was cited as a significant factor in reader polls.
Dosage form development, manufacturing, and analytical technology
1. FDA, Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach, Final Report (Rockville, MD, 2004).