By: Philippe Cini, PhD; Gretchen Allison; Gerald Leister; Eda Ross Montgomery, PhD; Julia O’Neill; Paul Stojanovski; Michael Thomas; and Arne Zilian, PhD
This paper introduced a process-capability maturity model with nine focus areas specific to the pharmaceutical and biotech industry. It also establishes a hierarchy of needs among those nine areas. Pharmaceutical and biotech executives that wish to assess whether and how process-capability indices may be used in their organizations may find this framework useful.
We conducted a survey in which participant companies were asked to rate their organizations on a scale of 1 to 5 in each of the nine areas: as they are today (current state) and as they intend them to be in 2–3 years (future state). On average, respondents indicated that their current state is close to the desired future state in five of the nine areas (policy, frequency, risk based approach, basis for specification and calculation consistency). There are four areas where on average respondents wish to continue to improve their capabilities (organization and skillsets, data management, response and commercialization). Among those four, two are foundational areas that should be addressed first (organization and skillsets, data management).
In general, respondents believe that such programs will help their companies comply with key regulatory requirements (process validation, process control) and improve the business bottom line by tracking and communicating process performance effectively; this, in turn, will drive continuous improvement.
Survey responses also indicated that process-capability index may not be a stand-alone program, but rather be integrated with key elements of a quality-management system such as APRs and various process-monitoring efforts in the context of a CPV program.
Last, but not least, respondents also emphasized the need for engagement of key functional areas such as technical services, quality and compliance, R&D, and product development for a successful process-capability program that promotes a culture of continuous improvement.
This information was first presented at the ISPE Annual Meeting & Expo, 8–11 November 2015, and was updated in 2016 and 2017.