By nature, pharmaceutical manufacturing operations are complex, inefficient, and consequently costly. Due to the inherent complexities, the cost of poor efficiency and its root causes are often not well understood by many manufacturers.
Contrary to what may be perceived—in most cases—the cost of manufacturing operations significantly exceeds that of research and development.
It is imperative to continuously identify the root causes for poor efficiency, classify and rank opportunities for improvement, and to undertake corrective measures to increase the productivity of manufacturing operations.
Without methodical, continuous, improvement initiatives in place, elevating efficiency in a meaningful fashion is unlikely.
Although many manufacturers have active continuous improvement programs in place, many are not reaping the expected benefits largely due to:
- Absence of a committed culture and a defined strategy.
- Unattainable expectations and bad assumptions.
- Insufficient training.
- Poor visibility to accurate, timely and actionable data.
- Focusing on treating the symptoms of inefficiency.
- Lack of understanding of the root causes.
- Unavailability of relevant, real-time, performance indicators on which to base decisions.
- Singular focus on equipment instead of overall production process.
- Inadequate understanding of process variability.
Arguably, continuous improvement is a major goal of PAT.
Successful continuous improvement programs must have a defined strategy, valid methodology, and the right process analytical tools.
Many pharmaceutical manufacturers have adopted methodologies such as Kaizen, Lean, and Six Sigma as part of their continuous improvement initiatives.
Knowledge Management and Decision Support Tools
Once an organization has determined their strategy and methodology for continuous improvement, it is imperative to select the right knowledge management and decision support tools.
This is not necessarily a simple task; quite often, the existing business systems and manufacturing operations infrastructure are complex and involve incompatible technologies, legacy systems, multitude of suppliers, disjointed connectivity, and insufficient security.
Ideally, the chosen tools:
- Must work regardless of methodology selected for continuous improvement. Best practices often require a hybrid approach.
- Won’t require changes to the existing infrastructure, and must work with existing systems and processes regardless of make, model, vintage.
Effective, continuous improvement programs must leverage subject matte experts, involve cross discipline teams, use analyti tools, follow best practices, and regularly execute corrective actions.
There are many current and new tools available that enable scientific and risk-managed pharmaceutical development, manufacturing, and quality assurance.
These tools, when used within a system, can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge. in the PAT framework, these tools can be categorized as:
- Data acquisition and analysis tools.
- Process analyzers or process analytical chemistry tools.
- Process monitoring and control tools.
- Continuous improvement and knowledge management tools
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