How can one ensure that staff are fully competent, with the right degree of technical confidence to work in a highly regulated
and scientifically challenging GMP manufacturing environment? How can one optimize staff performance to increase productivity,
minimize costly errors, and generate tangible returns to the business? And how can this be done in a cost-effective way while
meeting quality standards in a rapid timeframe?
These types of questions affect all biopharmaceutical manufacturing operations. Traditionally, to ensure the optimal performance
at a manufacturing site, management teams have focused on the quality management of the product and its process. As a result,
a wide variety of methodologies and practices have evolved, and a significant variable present at every site has often taken
a lower priority: the development of the workforce (see Figure 1).
Figure 1: Key factors in optimal manufacturing performance.
A common approach to training staff involves the "buddy" system. Typically, this approach pairs a new hire with a more experienced
colleague who has responsibility for training the new team member. Although this approach has merits, it also has significant
drawbacks and can result in an inconsistent training process across an organization.
The challenge of training staff for the biopharma industry has been particularly acute in Ireland, where the pharmaceutical
sector has experienced significant growth over many years. The sector accounts for 50% of Irish exports and generated a record
€55 billion (approximately US $68 billion) in 2011. Thirteen out of the top 15 global pharmaceutical companies have a manufacturing
presence in Ireland, which produce 5 of the top 12 global drug products, consolidating Ireland's position as the largest net
exporter of medicines in the world (1).
Following extensive consultation with industry and academia, the Irish government decided to address this training challenge
by establishing the National Institute for Bioprocessing Research and Training (NIBRT), which officially opened in Dublin
in June 2011 (2). Beginning in this issue of BioPharm International, NIBRT's experts will provide regular expertise and commentary on best practices for key bioprocessing steps (see for Ian
Nelligan's perspective on upstream processing). Podcast interviews with NIBRT training experts will also appear online at
THE TRAINING MODEL
NIBRT provides a broad range of training and education programs to a wide variety of companies, including Merck Sharp Dohme,
Amgen, Lilly, Johnson and Johnson, Pfizer, Elanco, Genzyme, and Allergan. The organization's approach is based on a Five Cs
model, where the Cs represent: Competency-based learning, Customized courses, Certified programs, Continuous professional
development, and Cost effectiveness (see Figure 2). These components are described below.
Figure 2: NIBRT’s approach to training, the Five Cs Model.
Competency-based learning ensures that trainees have significant hands-on, practical training experience in a GMP-simulated
environment. This type of training is typically not possible in an operational manufacturing environment where the equipment
is dedicated to production. The NIBRT building, for example, where training is held, holds a 6500-m2 state-of-the-art pilot-scale manufacturing plant. The building includes upstream, downstream, fill-finish, and complete
process and product bioanalytical characterization facilities. ISPE recognized the plant with a 2012 Facility of the Year