It is understood that in today’s complex pharmaceutical landscape, the need to maintain a high level of quality is paramount to success. And yet, despite the increased emphasis on quality in the pharmaceutical industry, it remains a significant challenge for manufacturers. One only needs to look to the growing amount of FDA Warning letters (235 from 2013-2016) to see that quality management is yet to be mastered.
Pharmaceutical Manufacturing recently partnered with EtQ to survey pharma and biopharma professionals regarding their opinions on how their companies, which ranged in size from small to large, handle quality, compliance and risk management.
The right quality management system, properly configured, will help enable an organization to meet both customer and regulatory requirements, while continuously improving effectiveness and efficiency. Perhaps most disappointing is that less than half of survey respondents feel their QMS offers improved data integrity and data quality. Not noting improved data integrity as a leading benefit is not isolated to one type of QMS– those using all four methods of QMS management (manual, homegrown, SharePoint and commercial software) failed to report increased data integrity as a prime benefit.
Very telling is that less than half (46%) of those surveyed feel the Quality/Compliance Management system in use by their organization is effective in managing quality and compliance needs, while 34 percent remain unsure and 20 percent can definitively say their systems are not effective.
If you consider CAPA the “heart” of compliance management it is disappointing to see that only 52 percent of those surveyed feel their organization has a robust CAPA process. And yet, it is not uncommon for FDA Warning Letters to cite insufficient CAPA programs as major compliance weaknesses in pharma.
Almost everyone surveyed (90.6%) named root cause analysis as the biggest weakness in their CAPA process. Root cause analysis is a problem-solving process for conducting an investigation into an identified incident, problem, or nonconformity. The root cause investigation process is paramount to the success of the CAPA process, and continues to challenge the industry.
As the mindset on quality and compliance shifts, risk management planning and processes are proving themselves to be a comprehensive method for measuring operational efficiency and regulatory compliance
The good news is that close to 66 percent of those surveyed do in fact report that their organizations are using risk management to guide actions. Over 60 percent of those using risk management to guide quality decisions related to CAPA are satisfied that their companies have robust CAPA processes in place.
However, the next step in risk management is to go beyond simply assessing risk to actively managing those risks. Risk management ensures what you do with that risk assessment has an impact on reducing risk exposure to the organization, patients, and consumers. Over 55 percent of those surveyed cannot definitively say their companies have reached this level in risk management.
Enabling a proper compliance and quality management strategy will help build quality and security into the product lifecycle from day one. Download the full market research report now to get closer look at the quality/compliance processes, and which challenges present the biggest pain points. You can also download a related infographic specifically focused on CAPA and what industry professionals have to say about their CAPA processes.