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Agnes Shanley is senior editor of BioPharm International.
The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.
For the past few years, the Parenteral Drug Association (PDA) has organized a task force to study the impact of aging pharmaceutical manufacturing facilities on product quality, manufacturing efficiency, and regulatory compliance. This summer the organization released the result of its first formal study, which summarized 2015 data. Most of the respondents (64%) work in the biopharmaceutical manufacturing sector, and the remainder in small molecules. Nearly half said their facility was more than 20 years old.
One goal of the research, according to PDA, is to develop a common definition of what an aging facility is, or what aging processes or analytics are. Results suggest that regulatory post-approval changes and the time and investment that they require manufacturers to make, may be stifling any interest in investing in new technology or methods.
Of the 80% who responded to this question in the survey, 73% described their facilities’ operation as excellent or good, with the remainder saying it was fair or poor. Two thirds responded to questions about batch rejection rates, with 80% citing rejection rates of up to 4%, and another 15% seeing a range from 5 to 10%. As far as process improvements are concerned, 88% of respondents said that up to 30% of their processes receive improvements.
When asked about regulatory requirements and whether they encourage or discourage investments in improvements, 56% said they encourage investments in modernization, while 24% said they discourage, and 10% were undecided. Respondents agreed that the time required for post-approval changes can be considerable, 32% described time frames of up to two years, 62% said that they can take from two to 10 years, and 3% related that they take more than 10 years. A total of 92% of respondents estimated the regulatory costs for such changes to be below $110,000.
Budget allocation for improvements went mainly to facilities, where 68% of respondents saw the focus, while 51% said they went to process improvements, and 40% to better analytics. However, 13% of respondents said that their companies did not have an annual improvement budget, while another 18% did not know whether such a budget existed. Additionally, 42% said their companies did not plan to modernize their facilities, while 11% did not know.
Approximately 28% of respondents reported having an active technology scouting program, but 54% said their companies did not actively look for new technology, while 18% said that they did not know. For more on the survey, and an interview with PDA’s Aging Facilities Task Force leader Maik Jornitz, check Pharmaceutical Technology’s November eBook on Quality.