Challenges pharmaceutical companies face when navigating the complex web of global regulatory requirements

For pharmaceutical companies, though, the path to compliance is filled with many challenges. These challenges emanate from various factors, making it crucial for the companies to navigate this tightrope skillfully and with the right tools.

Let’s look at some of the challenges:

Meeting Globally Variant Regulatory Requirements

One primary challenge is that the pharma industry deals with multiple standards and regulations, especially since it operates in different geographies. While most regulations across countries are based on ISO standards, variations can occur that need to be factored in and the processes duly aligned for compliance.

For instance, in the US, FDA (Food and Drug Administration) provides the regulatory guidelines, while Europe follows the European Medicines Agency (EMA). Though there is an effort to harmonize the different requirements, variations continue to exist, adding complexity to the processes. Constant monitoring, updates, and modifications to the processes are essential to remain compliant. Noncompliant companies may be levied severe penalties such as fines and product recalls. In severe cases, the manufacturing operations may be suspended.

Compliant with Good Manufacturing Practice (GMP) guidelines is also essential. Pharmaceutical manufacturers must implement systems that ensure the consistent quality of the products manufactured. Some of the key requirements include preventing unauthorized access to sensitive data and production areas.

Periodic Revisions of Regulations and Standards

While continuous improvement of the quality management system is required, the regulatory bodies and standards organizations also constantly review and revise quality and safety processes. This ensures that the quality and safety frameworks and regulations keep pace with the technological and evolutionary changes of the various industries they govern. For instance, paper documents are being replaced by electronic documents but standards have evolved to ensure these have all the required validations to pass muster and are not tampered with.

Pharma companies must also track each of the applicable regulations and standards to stay up to date and make corresponding changes to their processes as and when required within the stipulated time. They may need to work with third-party agencies and consultants and modify their own internal processes to remain compliant.

Efficient Utilization of Resources

Regulatory compliance requires investment in resources, which can drain pharma companies’ costs and time. This can affect the overall cost of manufacturing and time to market of new therapies and drugs, some of which are time-dependent, like personalized or cell and gene therapies. Even for more common drugs, it can affect the competitiveness of the brand, giving an advantage to early movers.

Optimizing resources while maintaining the balance between cost and time efficiency on the one hand and compliance on the other can be a big challenge. Ensuring employees are aware of the need for compliance, enforcing standard operating procedures, and keeping them updated through constant changes can also be discouraging and difficult for organizations already struggling with long development cycles.

Risk Management and Continuous Improvement

All regulatory bodies and standards encourage a risk-based approach to quality and safety. This requires businesses to identify risks, prioritize them, and implement mitigation strategies for potential high risks. This requires a data-oriented approach as it helps create a centralized repository, identify recurring issues, assign a score and rank them based on frequency of occurrence and severity of impact, determine the root cause, and trigger CAPA to take corrective and preventive actions.

This requires the employees’ involvement to proactively identify and report potential issues and engage deeply to ensure a quality culture. Leadership involvement and employee engagement form two core pillars of compliance, and strong systems and processes are needed to ensure their alignment with internal and external standards.

Supplier management also forms a key factor in compliance, as inputs determine the quality of the output. Therefore, supplier management rights from onboarding are an essential element in compliance.

Cloud-Based Solution for Smooth Navigation of Compliance Requirements

ComplianceQuest is a cloud-based quality management system built on Salesforce that is aligned with ISO standards. Its features are aimed to integrate processes end-to-end and facilitate compliance with different regulations based on geographical location. This provides quality leaders with the data to efficiently manage the regulatory requirements, identify risks and opportunities, and continuously improve the QMS. Some of its key features include:

• Audit
• Inspections
• Document
• Training
• Equipment
• Risk
• Change
• CAPA
• Complaints
• Supplier
• Dashboards
• Digital SOP

To know more, visit Compliancequest.com