Data integrity is critical in pharmaceutical process analysis because it ensures the reliability, accuracy, and consistency of data used to manufacture, test, and release pharmaceutical products, nothing surprising about that!
Compliance with Regulatory Standards
Regulatory authorities like the FDA, EMA, and WHO mandate stringent data integrity practices to ensure that pharmaceutical products are safe and effective. The FDA provides guidance on data integrity in pharmaceutical manufacturing through several documents and regulatory expectations, primarily aimed at ensuring the accuracy, consistency, and reliability of data in compliance with Good Manufacturing Practices (GMP). The most notable guidance is titled “Data Integrity and Compliance With Drug CGMP: Questions and Answers”, first issued in 2016 and updated in 2018.
Violations of data integrity can result in severe consequences, including product recalls, fines, or suspension of manufacturing licenses.
The US FDA defines data integrity as the “completeness, consistency, and accuracy of data” throughout its lifecycle.
In Europe The Pharmaceutical Inspection Co-operation Scheme (PIC/S), which includes EU regulatory authorities, issued the PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments in 2021, detailing expectations for maintaining data integrity across GMP processes.
It covers areas such as:
Risk-based approaches to data integrity.
Lifecycle management of data.
Documentation controls and audit trail reviews.
Handling of data breaches and deviations.
Quality Assurance – Data integrity ensures that processes are consistently monitored and controlled, allowing the production of high-quality pharmaceuticals.
It provides traceability and transparency, which are essential for identifying and addressing process deviations.
Decision-Making -Reliable data is critical for making informed decisions during process development, optimisation, and troubleshooting.
It ensures that adjustments to manufacturing processes are based on valid and trustworthy information.
Risk Mitigation – Inaccurate or falsified data can lead to defective products, regulatory scrutiny, and reputational damage.
Maintaining data integrity minimises risks related to product recalls, financial losses, and legal issues.
Continuous Improvement – Pharmaceutical manufacturing often involves continuous improvement to enhance efficiency and reduce costs. Reliable data is essential for analysing trends and implementing process improvements.
Accurate historical data supports long-term innovation and compliance.
Trust and Reputation – Ensuring data integrity fosters trust with regulatory agencies, healthcare providers, and patients. It upholds the reputation of the pharmaceutical company and its commitment to ethical practices.
ALCOA++ Principles – Data integrity in the pharmaceutical industry is guided by the ALCOA+ principles, which emphasise that data must be:
Attributable
Legible
Contemporaneous
Original
Accurate
and with the plus: Complete, Consistent, Enduring, and Available. Now updated in 2024 to be ++ to add traceable.
All pharmaceutical companies should be looking to ensure that all vendors of software for data analytics can prove that their products meet CFR 21 Part 11 compliance requirements and also adhere to the ALCOA+ principles.
Ultimately, pharmaceutical manufacturers are looking to ensure patient safety as paramount. Given that pharmaceutical products directly impact human health, accurate data ensures the products meet quality, efficacy, and safety standards.
Errors due to compromised data integrity can lead to adverse patient outcomes, including ineffective treatments or harmful side effects all of which pharmaceutical organizations want to avoid.
Data integrity forms the foundation of trust in pharmaceutical manufacturing, ensuring the delivery of safe, effective, and high-quality medicines.
With all that considered, when should pharma companies be looking to have their data validated and in the approval system for traceability and integrity management? KAX Group would recommend that right from the very start – initial data acquisition, DoE, Methods and Models should all be validated and approved at every step. From initial design and testing through to final GMP approved models to be deployed on the production line.
A scenario could be – an excipient vendor is changed, the initial experiments and models need to be revalidated with the new excipient in case of impact on quality due to a change in raw ingredient. With the right software and fully validated data, it will be simple to go back, exchange the excipient and rebuild, reapprove new models for deployment on site. This is the exciting part of a new functional and business critical piece of software from KAX Group VEKTOR VAULT launching in 2025. VEKTOR VAULT has been developed to strengthen and underpin VEKTOR DIREKTOR and ProaXesS for pharmaceutical continuous manufacturing enabling end-to-end data integrity, approval and security, it is both fully CFR 21 Part 11 and ALCOA+ compliant.
Keep watching this space for news and updates on VEKTOR VAULT as we prepare for launch early in 2025. If you have any queries please connect with Brad Swarbrick, Rajani Davuluri or Joon sup Lee.
