Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
In the late 1980s, Big Pharma ruled in more ways than one. Today, small pharma is thriving. The outsourcing strategy Big Pharma latched onto in the mid-1990s has redefined the industry; explosive vendor growth resulted. Vendor services continued to grow throughout the 2000s, paving the way for small pharma to essentially outsource GCP regulated activities to an extent that was previously impossible; the services needed were simply unavailable until recent years.
Regulatory requirements for GCP quality systems, including vendor oversight, are another industry trend partially driven by the explosion of outsourcing strategies. Global regulators require sponsors (regardless of size) to have strong, stable GCP quality systems, including processes for and documentation of vendor oversight. With few exceptions, our industry now refers to the quality system across GxPs. The FDA, EMA, and ISO agree that a quality system should cover organizational structure, responsibilities, procedures, processes, and resources, as well as appropriate resource, compliance, and records management. A solid quality system includes quality assurance processes, oversight, etc. to execute, support, and document organizational compliance with global regulatory requirements. Quality system components and oversight are clearly defined (e.g., qualification and training, document controlled standard operation procedures, quality assurance auditing program, vendor management, deviations and corrective and preventive actions [CAPAs], change control, archiving and records retention, etc.). Responsibilities for company processes and tasks, including QMS-related processes, are defined and assigned.
In 2018, vendors are merging and large CROs are scooping up multiple small vendors. The big vendor is emerging where Big Pharma once ruled. The tables are turning, yet small pharma is still required to demonstrate vendor oversight. But how can a small pharma company outsourcing the majority of its GCP activities due to a lack of in-house experience and manpower oversee the work of the vendors it relies on to provide the very expertise it lacks?
Factors that contribute to the challenges small pharma have with executing proper vendor oversight include a lack of solid QA presence, inexperienced QA staff, and staff lacking the right QA experience for their assigned responsibilities. Potential drivers for these factors include intense focus on production of products and services, gaps in senior management understanding of regulatory environment and requirements, and inappropriate prioritization of quality system components in long-term strategies.
So, what is a small pharma company to do?
Ensure that quality systems basics are understood and embraced from top to bottom to establish a foundation on which to build appropriate vendor oversight. Even if you outsource 99 percent of GCP activities, you are the sponsor. This means that your company is required to have vendor oversight, regardless of your company size or the size of your vendor(s).
Include the following 10 key ingredients in your quality system using commonsense strategies:
Take your rose-colored glasses off and self-evaluate. Ask the following questions:
Take the following immediate actions to increase your knowledge, skillset, and confidence:
The current landscape presents both challenges and opportunities for small pharma. Challenges include regulatory authority expectations for oversight and the emergence of big vendors. The opportunity is to develop creative risk-based, common-sense approaches/models to establish, implement, and monitor quality systems that ensure patient safety, quality, and regulatory compliance. Don’t fall prey to the misconception that your small pharma company doesn’t need a quality system because your vendor(s) has one.
About The Author:
Penelope Przekop, MSQA, RQAP-GCP, is a quality management systems, assurance, and compliance consultant with 25+ years of experience in pharmaceutical GxP global quality systems with a key focus on clinical development, data management, and pharmacovigilance. Her areas of expertise include quality systems, quality assurance, regulatory compliance, inspection readiness, training, and strategic planning.
Przekop earned a B.S. in biological sciences from Louisiana State University and an M.S. in quality assurance/systems engineering from Kennesaw State University. She has held leadership positions in both Big Pharma and CROs, including Johnson & Johnson, Wyeth Pharmaceuticals, Novartis, and Covance. You can connect with her on LinkedIn