Written By: Shauna Clizbe, Technical Operations, PSC Biotech®
The biomanufacturing industry is currently undergoing a revolution in how it develops products. The major driving force behind this paradigm shift is known as Industry 4.0. This approach focuses on how to apply predictive modeling, data, analytics, artificial intelligence, and automation technology for the Digital Transformation of biomanufacturing manufacturing.
Companies are investing in improved analytics, process control, and more of the elements of Industry 4.0. Examples include using data and analytics from raw materials and bioproduction operations to improve the process with the goals of improving efficiency, lowering costs, and getting products to market faster.
Quality Assurance (QA) and Quality Control (QC) are of utmost importance in the production of API’s, pharmaceuticals, and biopharmaceutical products, not just to meet Good Manufacturing Practices (cGMP) standards and regulatory requirements, but as a major tool in the Digital Transformation. Processes and controls must be effective and enforced throughout your facility and process, from clean room operations to calibration of instruments and preventative maintenance in utilities systems.
While investing in better automation and analytics, biopharma manufacturers can take advantage of modular, pre-validated, and pre-tested single-use equipment, bioreactors, and chromatography systems that include built in electronic batch record (EBR) and manufacturing execution system (MES) functionality. Integration of these complex systems with a QC and QA team can be a complex and sometimes difficult task. Quality Control and Quality Assurance play inter-related and essential roles. Creating successful QC and QA programs within the organizations can be streamlined by following some best practices;
- Train your staff;
- Documentation is key, especially in the age of Industry 4.0;
- Perform at least an annual review of SOPs, policies, and programs;
- QA and QC must enable your efforts, not disable them;
- Be independent of the rest of the organization;