The factory of the future must consider the requirements of an ongoing changing product portfolio.
Mergers and acquisitions lead more frequently to product transfers and closing down of older factories. Shorter product cycles and changes on market demands may turn big production volumes to smaller ones and vice versa. The block buster model is decreasing and the diversity of the product portfolio will be increasing, which will have an impact on manufacturing facilities from a complexity and activity perspective.
New factories must be able to react, be flexible and timely on new regulatory requirements, changes in the product portfolio and changing demands. Equipment and product change-over times on machines have to be reduced without negative impact on regulatory compliance and patient health and safety. Single use technologies will be another option and investments need to be planned thoroughly and later, to meet changing market demands in a timely manner, which requires proficiency in project management. The factory of the future could be modular, to be able to reconstruct one part while produce in the other part.
Many innovative impulses will be derived from Industry 4.0 like automation, digitization and integration of computerized systems along the value chain, where data integrity has to be ensured in all functions of a pharmaceutical company, and integrated systems allow unfolding further saving potentials which would not be achievable in a siloed world.
Continuous manufacturing seems to be one of the most innovative approach to regulators, especially in the production of active pharmaceutical ingredients and biotechnological production when processes can be shortened, and availability of drugs in the market can be increased, which is of high interest for health agencies.
Another sector is using new technologies for “personalized medicine” which accelerates technologies supporting to the manufacture of small batches.
More mature are “single-use” technologies, which make extensive cleaning validation obsolete. Cleaning validation findings are still a hot topic and often the reason for findings in GMP inspections, if not handled in a correct manner.
On the one hand, regulatory agencies welcome innovation as long as quality and safety is not compromised. On the other hand, new approaches may lead to numerous questions from regulatory authorities, which might be perceived by the applicant as an innovation preventer. As consequence, the innovator must spend efforts to communicate and explain. Also for technical non-experts, they must explain the credibility and the quality risk management concept of the innovation.
In areas where continuous manufacturing will provide advantages, a trend has been established. High value and big volume products justify the investment in continuous manufacturing. Smaller products require adjusted processes via miniaturization of equipment.
New regulations from e.g. the World Health Organization (WHO) and the Food and Drug Administration (FDA) influence discussions in the Life Sciences industry. It is common sense that data integrity is a hot topic for the entire value chain, where compliance relevant data is being broadly handled. Completeness and correctness of data are also parameters of Good Manufacturing Practice (GMP ), thus data integrity can be seen as “GMP for data.” Hence, many companies have started standardization of data warehouses and frameworks for master data management, which lays the foundation for the successful implementation of data integrity requirements.
Using SAP solutions, life sciences companies can revolutionize R&D with the ability to analyze Big Data from various sources and in multiple formats, such as genome, proteome, and clinical trial data. They can speed the development of personalized medicine, facilitate collaboration, optimize project management and service procurement, and secure compliance with regulations.
Furthermore, SAP solutions help streamline manufacturing operations and maintain superior product quality across the enterprise. The solutions enable collaboration with global outsourcing partners to help ensure they meet regulatory requirements, adhere to compliant manufacturing best practices, and provide patients with safe and high-quality products.