Process compliance is crucial in new drug development and testing as it ensures that all regulatory requirements are met at each stage, from discovery to post-marketing surveillance. Compliance involves rigorous scientific research, data integrity, and adherence to Good Manufacturing Practices (GMP) and regulatory submissions such as the Clinical Trial Application (CTA) (Investigational New Drug – IND – application in the US) and Marketing Authorisation Application (MAA) (New Drug Application – NDA – in the US). It helps streamline the approval process, mitigates risks, and ensures the safety and efficacy of new drugs before they reach the market.
However maintaining compliance during the drug development process faces several challenges:
1. Regulatory Complexity: Navigating diverse and evolving regulatory landscapes across different regions can be daunting, leading to delays and increased costs.
2. Data Management: Managing vast amounts of data and ensuring data integrity are critical yet challenging tasks.
3. Standard Operating Procedures (SOPs): Lack of clear SOPs or failure to follow them can lead to compliance issues, as highlighted by frequent FDA citations.
4. Balancing Innovation and Compliance: Striking a balance between innovation and stringent regulatory requirements is essential but challenging.
Process control software like Malys Okuda no code tool for modelling, deploying and monitoring mission critical processes can play a crucial role in ensuring compliance during drug development by automating and streamlining regulatory processes. It enables real-time monitoring and reporting, allowing companies to promptly identify and rectify issues, thus preventing compliance breaches. The software also facilitates the management of critical quality attributes through process analytical technology (PAT), ensuring adherence to cGMP and ICH Q8 standards. Additionally, it supports comprehensive documentation, audit trails, and training management, which are essential for maintaining compliance with GxP guidelines. This integration enhances efficiency, reduces human error, and ensures regulatory adherence throughout the drug development lifecycle.
Drop us a message to find out more about how our no code Okuda tool can enable process control and compliance for new drug development SOP’s.