Data integrity was a crucial trend in warning letters issued by the FDA last year, along with a significant increase in international inspections. Industry analysts predict that in the months to come, regulatory agencies will place a continued emphasis on data integrity failures at pharma companies.
As a result, it's time to prepare for a successful inspection immediately. If your process monitoring or document management practices aren't fully aligned with regulatory requirements, you could face steep penalties and swift action. While pharmaceutical industry compliance requirements are complex, you can reduce regulatory risk by creating a healthy baseline for total compliance in the pharmaceutical industry.
It's never too early to start adopting the essentials for healthy compliance at startups or scale-ups. It's also not too late for commercial pharma organizations who are struggling with compliance or data quality. Fortunately, the wisest steps to streamline complex requirements could be easier than you think. An electronic quality management system (eQMS) and quality unit are the two essential tools for full-lifecycle compliance at pharma companies of any size.
Tools You Need for Regulatory Compliance in the Pharmaceutical Industry
There are no absolutes when it comes to pharma compliance. The specific regulations which impact your organization depend on your phase. If your company is pre-commercial, you are required to comply with FDA 21 CFR parts 50, 54, 56, 312, and 314. It can also depend on your organization's location—EudraLex impacts EU organizations.
While specific requirements can vary, the essential elements of effective compliance are generally the same across the industry:
- Your organization needs an electronic system to implement quality management and act as a comprehensive system of record.
- You also need a quality unit to manage and implement the quality system.
Pre-commercial organizations can benefit from adopting compliance processes and systems that can scale to future requirements.
Essential #1: eQMS
A robust electronic quality management system (eQMS) tool is necessary to manage the required records for compliance at any stage of the pharma company lifecycle. FDA regulatory education based on the Compliance Program Guidance Manual (CPGM) 7356.002 states an eQMS should:
- Include the quality control unit and all quality unit review and approval
- Assure and govern the manufacture of a quality product
- Assure overall compliance with cGMPs and internal SOPs
Many pharmaceutical startups don't take on the costs of an eQMS implementation because resources are focused on the development process. Delayed adoption is frequently a mistake.
Building quality into the core operating model of the organization by implementing a pharma-oriented QMS software simplifies approval processes later. Having to retrofit a paper-based quality system to fit an eQMS is virtually always more painful, time-consuming, and costly than if an eQMS had been used from the start.
THE BENEFITS OF EQMS
Using a paper-based approach to apply a quality management system may have been a sufficient approach for smaller pharmaceutical companies in the past, but it can significantly increase the risks of non-compliance with cGMP at regulated organizations.
Implementing an eQMS in the development phase can introduce efficiency and effectiveness, and enable the organization to meet compliance requirements from the start. Several of the compliance benefits of eQMS include:
- Globally-connected operating processes
- Smarter document and data management
- Better data retention and access
- CAPA management capabilities
For more on this topic, check out: QMS Software: 7 Features That Save You Time, Money, and Resources.
Essential #2: A Quality Unit
The quality unit in pharma plays an integral role in managing the records needed for compliance in development, process, finished product, environmental controls, and other aspects of the process. The role and responsibilities of the Quality Control Unit are defined in 21 CFR parts 210 and 211 (1). European Union cGMP regulations require units for quality control and assurance.
A quality unit is the operational arm of the pharmaceutical quality management system, which is responsible for implementing and maintaining the success of all quality activities. While the QMS is the framework, the quality unit is the executor of the framework. The responsibilities generally include:
- Establish a quality system
- Audit compliance to the QMS
- Establish standard operating procedures (SOPs)
- Create manufacturing controls
- Perform laboratory tests and examinations
- Review and implement all cGMP
- Investigate nonconformance
- Regularly report to management
- Update SOPs
The pharmaceutical quality unit is among the essential tools for compliance because it is the only job description named in the FDA CFR. Failure to implement and maintain a comprehensive quality unit can lead to many compliance issues, FDA warnings, or product quality problems.
The Added Benefits of Pharmaceutical Industry Compliance
An eQMS and a quality unit are the essential elements for total compliance in the pharma industry at organizations of any size. By adopting the essential elements in the development phase, pharma startups can avoid the costs and time-consuming problem of having to adopt compliant systems or implement new approaches in the future.
At organizations of any size or stage, the two compliance essentials can also carry the benefits of quality and profitability. With a quality-driven culture, you'll avoid the risks of non-compliance and associated financial penalties. You'll also reap other benefits such as greater operational efficiency, superior product quality, and more effective collaboration. Compliance may be a requirement, but the most critical tools for compliance can drive a healthier culture and stronger profits.