Quality assurance (QA) is crucial in the pharmaceutical industry to ensure that products meet regulatory standards and are safe for consumption. With safety at stake, maintaining the highest level of quality is non-negotiable. Following QA best practices is necessary for pharmaceutical companies to uphold their reputations and safeguard patients.
[To learn more about how to innovate for quality assurance, view the guide.]
Top quality assurance best practices to follow.
Here are three best practices to implement for quality assurance:
1. Understand the regulatory landscape to meet compliance: Understanding the regulatory landscape enables quality managers to proactively identify and address any gaps in their organization's quality processes, ensuring the safety, efficacy, and integrity of their products.
However, meeting compliance requirements can prove challenging with ever-evolving regulatory standards and varying international regulations. To help ensure compliance, look for a solution with automated and on-demand process tracking that offers continuous updates as well as the ability to tailor processes to comply with varying international regulations and the flexibility to adapt as the regulatory landscape changes.
2. Ensure data integrity: To prove compliance with Good Manufacturing Practices (GMP) standards, you need quality data. Regulatory bodies require accurate and reliable data reporting across manufacturing, quality control, and documentation.
To streamline data gathering and ensure data integrity, establish a single source of truth. Creating a unified dashboard that can automatically pull real-time quality and product data from across systems will reduce time spent gathering data and will ensure the accuracy of data for reporting.
3. Orchestrate effective change management: With ever-evolving regulations and quality requirements, change is necessary in the pharmaceutical manufacturing process. However, even minor process changes can have significant implications on product quality.
Properly executed change control management can identify and mitigate risks as they appear throughout process changes. This includes documenting change requests, assessing risks, obtaining approvals, and implementing changes in a controlled manner.
Find a solution that can efficiently and effectively manage change requests with capabilities such as:
- Electronic submission of change requests (CR), facilitated by automatically assigned CR numbers
- Enhanced compliance with improved handling of complex GxP logic and automated, compliant electronic signatures
- Real-time visibility with audit trail into CR status for relevant participants across all departments
Quality assurance is the cornerstone of the pharmaceutical industry, safeguarding the integrity and safety of products. By adhering to these best practices, pharmaceutical companies can enhance their QA processes, mitigate risks, and uphold the highest standards of quality and compliance. Ultimately, prioritizing quality assurance not only ensures regulatory compliance but also instills trust and confidence in consumers, reinforcing the industry's commitment to patient welfare.
How to uphold quality assurance best practices.
To help uphold these best practices, organizations should implement a solution that can enhance visibility and traceability, provide process flexibility to adjust to changing compliance requirements, and streamline workflows. Embracing a platform with built-in automation capabilities can significantly improve efficiency, enhance data quality, and ensure consistency across operations.
To learn more about Appian’s process automation capabilities for quality assurance, view the guide.
