New technologies and digitization efforts within the pharmaceutical industry have created exciting opportunities for improvement and innovation.
While exciting, strict regulatory oversight has slowed the adoption of many of these technologies. Some companies may feel intimidated by rigid data integrity and pharma qualification and validation document requirements; however, that doesn’t have to be the case.
Pharma manufacturers willing to adapt to unique challenges can benefit significantly from these new opportunities for increased efficiency and quality. That’s why many companies have started their journey to reaching Pharma 4.0
What is Pharma 4.0?
Pharma 4.0, a term created by the International Society for Pharmaceutical Engineers (ISPE), serves as a roadmap for adopting new technologies and strategies to increase efficiencies and optimization.
Pharma 4.0 focuses on creating improvements throughout a product’s lifecycle to enhance connectivity, transparency, and productivity—working together to simplify compliance, provide greater control over operations, and allow for quicker decisions.
Facilities of the Future
Another term coined by ISPE, “facilities of the future,” refers to manufacturing facilities using innovative design concepts, new technologies, and unique solutions to bring themselves into a new era of pharma development, Pharma 4.0.
Three technologies we anticipate being popular within facilities of the future are integrated continuous manufacturing, holistic automation networks with elements of Artificial Intelligence (AI), and blockchain.
Below we have outlined our top CQV tips for each.
Integrated Continuous Manufacturing
- Start with the recent ISPE Draft Guidance for Continuous Manufacturing to understand the process description of this novel approach.
- Maximize and leverage the lifecycle of your product.
- Focus on the design phase for risk assessment and controls. It’s critical to identify and focus on:
- Product quality
- Patient safety
- Data integrity
- Assess process analytic technology capabilities beyond just calibration.
- Your CQV approach must be performed at each unit of operations level (for IQ and OQ), followed by fully Integrated Operational Qualification.
- Your Computer System Validation (CSV) should follow the systems life cycle development (SLCD) process with a focus on Good Automated Manufacturing Practice (GAMP), Electronic Record, Electronic Signature (ERES), and data integrity.
- For PQ/PV, consider that the desired end-state is a Continuous Process Verification (CPV). This is accomplished through:
- Monitoring CPP trending (i.e., parametric release)
- Confirmation from a QC Lab (for final confirmatory release if needed)
Holistic Automation Networks with Elements of Artificial Intelligence (AI)
- Involve your validation team early in the design process.
- For AI elements, check evidence of successful proof-of-concept (PoC) confirmed during the development phase.
- Check evidence of data integrity in the design phase.
- Build your requirements based on the development output, not on the vendor’s input.
- Your CSV should follow the SLCD process with a focus on GAMP, ERES, and data integrity.
- Focus on data integration and traceability (solid test scripts, leverage on software vendor testing).
- A vendor audit is critical.
Blockchain
- Adoption of this technology is mainly for anti-counterfeit efforts (supply chain), not as much for manufacturing validation, except for serialization packaging lines.
- Involve your validation team early in the design process.
- Check evidence of data integrity in the design phase.
- CSV should follow the SLCD process with a focus on GAMP, ERES, and data integrity.
- Build your requirements based on the development output, not on the vendor’s input.
- Focus on data integration and traceability (solid test scripts, leverage on software vendor testing).
- An audit of any software vendors and integration services providers is critical.
Need CQV Help?
Whether you’re looking to implement any of the new technologies mentioned above or improve your already existing infrastructure, ICQ’s expert team can help with all your commissioning, qualification, and validation needs.
