Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS) translates to safer products and better organizational performance and profits.
Philosopher George Santayana once stated, “Those who cannot remember the past are condemned to repeat it.” This sentiment of not learning from your mistakes holds true when building and maintaining a QMS. A QMS should continuously evolve to meet new or changing business demands and regulatory expectations. These changes provide plenty of opportunities to evaluate and improve your processes.
ProPharma’s compliance experts routinely observe which attributes of quality systems work well and which are a struggle for firms to maintain compliance in a regulated industry.
Eight common avoidable mistakes that stress a firm’s ability to maintain compliance with their established quality system:
- One size fits all: Companies should not be fooled into purchasing an off-the-shelf QMS. Every organization conducts their operations uniquely, an off-the-shelf QMS may not be appropriate for the type of business, phase of development, company culture, etc. that a company may have established.
- Not phase appropriate for your clinical development: As products advance along the product lifecycle, GMP requirements become more stringent. A full-strength QMS designed for a commercial product is usually too rigid for development phases where flexibility to change is necessary as new product knowledge is obtained. A risk based QMS for phase 1 clinical trial material should be developed to ensure basic safety and documentation standards are met and to encourage the design of quality into the process. It is expected that enhanced process controls and GMP standards will be employed as the material transitions into later clinical stages. Phase appropriate risk-based approaches allow a company to focus on critical items and spend less time worrying about the minor stuff.
- Not updated with the growth of your organization: This speaks to the little “c” in cGMP. As industry trends, technology, and experience changes, so does the expectation of the requirements for quality system elements. Updated procedures are necessary for maintaining a state of control.
- Too many redundant Standard Operating Procedures (SOPs): Over time a quality system can become bloated, making it difficult to follow as written. Or the network of references to other SOPs may be nearly impossible to track. When one SOP is revised, you must trace all the SOP references to make sure they also do not need to be revised. Compliance to such a system may become unsustainable. This can occur incrementally with small changes like modifications resulting from audit findings, or revisions due to Corrective Actions and Preventive Actions (CAPA), these subtle changes may be unnoticeable until it is too late and you have lost control of it. Once these changes add up it becomes too cumbersome of a system to maintain compliance. Combining procedures, removing redundancy, and simplifying processes can alleviate this.
- Missing the key components that lead to regulatory inspection findings: A QMS that is not aligned with the current expectation and requirements of regulatory authority invites observations, potential delays in approvals, or recall. New guidance is routinely issued and is expected to be incorporated into your QMS. Having a current QMS removes the burden of costly observation remediation and otherwise justifying why there is no resulting adverse impact.
- Losing sight of the fact that just having a perfect QMS is enough for compliance: Building and maintaining a compliant QMS does not make you compliant. A firm must follow its QMS as written and build in quality throughout the lifecycle of its products, trials, and services. Compliance means saying what you do and doing what you say.
- Not obtaining cross-functional input from Subject Matter Experts: Many SOPs cross multiple functions and departments and require input from all impacted groups. At ProPharma Group, we have more than 1,200 colleagues with varying expertise that we can leverage for any process or program in the life science industry.
- Not based on lessons learned: Your QMS is the foundation that bridges regulations, guidance, and expectations with how your firm conducts its daily quality operations. Reflecting on George Santayana’s statement, if your QMS is not considered as a platform for continual improvement, you are destined to lose a foothold on compliance.
Ensure Your QMS Achieves Three Objectives
Drawing from relevant regulatory authority regulations, guidelines, and industry practices, our global experts assess your QMS to identify improvement opportunities to help ensure that regulatory compliance and industry best practices are met. Our quality systems team makes sure that suitable process performance is achieved, the set of controls are appropriate, compliance opportunities are identified and evaluated, and the body of knowledge is continually expanded. With this, we focus on three primary objectives:
- Continuous improvement
- Risk-based regulatory requirements and expectations
- Phase appropriate “right-sized” processes for the phase and scope of the organization
Whether you are proactively looking to develop and implement a Quality Management System or need to optimize your existing system, our team can help.
ProPharma is Your QMS Support Expert
A proactive, phase appropriate, and risk based QMS approach can substantially reduce the risk of a catastrophic incident that could jeopardize your trial, drug, or device’s future. A robust QMS will enable you to successfully bring your product to market.
ProPharma's Life Science Consulting team is made up of subject matter experts who can assist with Clinical and Commercial Quality System design including risk management, quality manuals, SOPs, CAPA design and processes, risk management plans, and communication plans. We also assist with Quality System implementation as needed. Additionally, we can conduct qualifying audits for sites and vendors, and perform routine audits for ongoing trials, CMOs, and CROs.
Whether your needs are for implementing, maintaining, or remediating a Quality Management System, our experts are here to help. Contact us today for a complete evaluation of your current QMS.