The Best Strategies to Modernise Pharmaceutical Quality Systems
Sofia Lange, Director of Strategy, Vault Quality & Manufacturing, Veeva Systems
Despite individual regulatory bodies having their own unique set of requirements, for most organisations, the challenges associated with annual product quality reviews (APQR) are largely the same. Issues with fragmented systems and paper-based processes prove increasingly burdensome.
APQR is essential to ensuring consistency of production processes across product lines, assessing the appropriateness of specifications and identifying opportunities for improvements. Due to the complexity of gathering the necessary information, organisations may undertake these reviews with the goal of merely meeting the regulatory obligations. This often means they are missing out on opportunities to make improvements across the board.
Common APQR Challenges
To demonstrate good manufacturing practices (GMP) compliance, quality teams spend a significant amount of time compiling the information required by the authorities for the APQR. This often means that important analysis of trends and identifying opportunities to improve the product and processes is left behind.
To ensure inspection readiness and achieve operational excellence, here are four ways to streamline common APQR pitfalls:
Limit manual, paper-based processes: Many quality assurance teams still manually compile reports and review information from paper or legacy systems. This is not only time-intensive but increases the chance of human-error occurring, which puts data integrity at risk.
Hold third-party partners accountable: Contract manufacturers or other external partners can make gathering information for product quality evaluations even more challenging. It is important for partners to outline obligations for completing the APQR via contracts or quality agreements. If not well defined and established in advance, quality teams have no choice but to rely on downloading and manually reviewing data and documents from partners, resulting in increased complexity.
Unify your data: By enabling greater communication among quality systems and expediting data gathering and sharing, enterprises can ensure proactive management of quality. Ultimately, data integrity is compromised when businesses use a multitude of systems, spreadsheets, and paper. By avoiding working across fragmented QMS, ERP, MES, LIMS, and other systems, APQR systems can be readily streamlined.
Monitor your progress in real time: Despite progress being measured against the annual APQR plan, usually there is a lack of visibility when it comes to the progress of information gathering for different sections of different products. Detailed metrics can provide transparency related to how mature an organisation is and may help to allocate existing resources. Teams using this information have the capability to create Corrective Action and Preventive Action Plans (CAPAs) for ongoing improvement.
Modernising your Quality Systems
An effective way for businesses to streamline the execution of APQRs is by utilising unified quality systems with features such as review workflows, document production based on report data, and open APIs that make it easy to integrate with other applications. This enables organisations to implement a system that brings together data and workflows for alignment with external partners and real-time visibility while maintaining data integrity.
When looking at an advanced quality solution, there are several essential functions that will result in smooth APQRs:
Templates: A customised APQR table of contents can fit the requirements of various products and geographies. These templates can specify the exact type of content or APQR report items necessary for inclusion in the final report.
Automation: By automating procedures and generating trend reports, you can ensure access to key information, while reducing reliance on paper. Data quality and compliance can be improved by automatically producing APQR templates, documentation, product-specific trend reports and binders when gathering necessary data.
Role-based task assignment: Streamlining execution enables authorised users to generate APQR records directly from the template. Role-based access streamlines review and approval processes and promotes accountability, ownership and traceability.
Workflows: Each section of the APQR can be assigned to a dedicated team and can be individually followed upon completion. This saves time by enabling parallel completion, allowing detailed oversight and promoting active engagement across functional teams. A modern system is essential to providing thorough audit trails that can lower compliance risk and improve data integrity while allowing careful monitoring of GxP (good practice) requirements.
Digital APQR binder: The automated creation of a digital APQR binder can be transformational for quality teams and regulators who need to examine papers. This binder contains all content referred to in the template, without the use of paper or spreadsheets. Easier access and verification therefore create a smoother review overall.
The Power of Digital Quality Processes
By implementing digital tools and procedures, companies can reduce the manual, dispersed, and paper-based APQR processes commonly used. A unified system on one platform empowers increased efficiencies by allowing data flow, real time reporting, and process automation. By taking a unified approach, organisations can easily combine APQR data from several sources, enable simultaneous execution, and obtain confidence that information is correct and readily available. Ultimately, this allows businesses and regulators to enjoy a smoother and more collaborative APQR experience while focusing on desirable continuous improvement outcomes.