Almost half of respondents indicated that their company applies QbD principles for both new and legacy products, and another
32% apply QbD to all or select new products (see Figure 3). Only 22% of respondents do not apply QbD at all. Approximately
72% identified better process understanding as a benefit of QbD. Participants were invited to choose all answers that applied,
and they indicated other benefits of QbD as increased efficiency/reduced waste (48%), reduced costs (44%), shorter process
times (35%), streamlining regulatory review (32%), and improved ease of making changes (29%). Only 6% of respondents felt
that there are no challenges or barriers to implementing QbD. More than half noted lack of knowledge and training as a problem.
Approximately 42% indicated clarity of regulatory guidance as a barrier. Only about one-third of repondents chose, respectively,
lack of management buy in, availability of software, or availability of equipment as barriers to QbD implementation.
Figure 3: Application of quality-by-design (QbD) principles to manufacturing processes (% of respondents).
Over half of respondents indicate that they use PAT, which is an increase from last year’s survey that found only 40% of respondents
incorporating PAT (1). When asked to indicate the primary drivers for using PAT (multiple answers permitted), nearly half
of respondents chose increased efficiency/reduced waste; others chose better process understanding (44%), reduced costs (33%),
and shorter process times (31%). Almost 10% indicated that their company mandates use of PAT, and nearly 6% said their customers
request it. Sterile manufacturing/aseptic processing and lyophilization are areas of potentially strong growth for the use
of PAT. As shown in Figure 4, 14% of respondents in these areas use PAT now, but an additional 50% plan to implement PAT in
the coming year. Compared to the other categories, a higher percentage in solid-dosage manufacturing (22–26%) already use
PAT, but a lower percentage (24–25%) plan to add PAT in the coming year.
Figure 4: Current and future use of process analytical technology (PAT) (% of respondents).
Continuous manufacturing is still a new technology, but is being considered as an alternative to traditional batch processes
for solid-dosage manufacturing. Respondents indicated (multiple answers permitted) multiple barriers to implementing continuous
- lack of equipment (46%)
- insufficient expertise (42%)
- cost (36%)
- concern over regulatory acceptance (29%)
- insufficient PAT (23%)
- lack of appropriate documentation systems (15%).
Nearly all agreed, however, that technology will continue to evolve and use of continuous processing will increase.
Pharmaceutical Technology’s Equipment and Manufacturing Survey targeted individuals in production and engineering. The survey
was conducted by email in February 2013 and had 193 respondents. Nearly 30% were from innovator pharmaceutical companies,
28% from generic-drug companies, 20% from contract manufacturers, and 10% from consumer healthcare companies making over-the-counter
products. The remaining respondents included excipient and raw material suppliers (7%) and equipment or machinery vendors
(5%). About half of the respondents were involved with solid-dosage manufacturing and the other half in parenteral drug manufacturing.
The majority of respondents (79%) were from companies with under $1 billion in revenue. Nearly 7% were from companies with
between $1 to $10 billion in revenue, almost 7% were from companies with $10 to $50 billion in revenue, and the remainder
(8%) were from companies with over $50 billion in revenue.
1. P. Van Arnum, Pharm. Techol. 36 (4) 50-60 (2012).