Pharmaceutical companies, spurred by industry forces and a changing regulatory climate, seek new processes and approaches to improve manufacturing efficiency, productivity, and quality. New cost pressures related to dwindling pipelines, greater competition from generics, and a challenging global economy have reduced pharmaceutical manufacturers’ traditional reluctance to embrace advanced manufacturing processes.
The US Food and Drug Administration has been urging drugmakers to build quality into the manufacturing process from the start, as opposed to relying on end-process testing, with its process analytical technology (PAT) and Pharmaceutical CGMPs for the 21st Century initiatives. These initiatives seek to enable consistent and predictable product quality (i.e., higher sigmas). PAT requires manufacturers to understand how manufacturing variables affect product-quality attributes and to measure quality using those attributes during the manufacturing process. To adopt the PAT model in a continuous-manufacturing environment, pharmaceutical organizations must monitor key product attributes during production and make in-line adjustments to the manufacturing process to keep the product within specifications.
An integrated information technology (IT) environment that captures and displays data from every part of the supply chain and manufacturing process is essential to the PAT approach, as is a flow of information across the enterprise. Information flows, enabled by an organization’s IT infrastructure and enterprise applications, must complement and keep pace with the flow of materials in a continuous environment. The flow of information supports long-running product orders of various sizes, captures in-process quality-test results electronically, includes them in the electronic batch record, and enables timely interventions.
To understand the relationships between manufacturing-process parameters and product quality, pharmaceutical manufacturers must transform data from every part of the supply chain and manufacturing process into accessible and usable knowledge. For example, pharmaceutical manufacturers sometimes purchase one active pharmaceutical ingredient (API) from several suppliers, and the API’s strength and particle size might vary according to its source. It is therefore important for pharmaceutical companies to know the source of each API, the typical quality profile of the API, and how to make process adjustments to compensate for material variability.
An integrated IT infrastructure is essential to enabling manufacturers to capture the secure, analyzable, and actionable data needed to identify variability and make appropriate production adjustments to ensure consistency and high quality. The infrastructure must also be able to collect and interpret data from multiple internal systems and contract manufacturers.
Advanced software suites available today help manufacturers manage in-process material variability within a particular batch and its corresponding manufacturing processes. Such solutions allow manufacturers to adjust for differences in potency between different lots of the same API. For instance, if a user selects a lot that has substandard potency, the system will instruct the operator to use more of the API or less of a buffer ingredient to reach a consistent batch potency. This type of flexibility and functionality is critical to effectively manage the pharmaceutical process to produce consistent product quality.
Pharmaceutical manufacturers face great challenges today, but they have new opportunities to deploy effective and efficient manufacturing and quality-control processes that were not viewed as necessary or viable until recently. The industry also has access to a new generation of advanced and integrated IT solutions that support PAT and other initiatives by enabling the essential flow of actionable information from the supply chain through the manufacturing and distribution processes. By harnessing the power of new processes and technologies, the industry stands to make great strides toward achieving new levels of operational efficiency, quality, and corporate performance.
John Danese is the life-sciences product strategy director at Oracle, 560 White Plains Rd., Tarrytown, NY 10591, tel. 914.239.3788, fax 914.524.1673, [email protected]