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Managing the risks of PAT: operational excellence awaits, but only if you can implement PAT successfully.

Article Excerpt
Many companies are adopting or extending PAT solutions to achieve product innovation and process improvements through engineering development and manufacturing performance. Typically, quality units Quality Assurance or Quality Control operate within budgets representing 20-30% of manufacturing costs, but industry statistics indicate that adopting PAT could reduce this figure to <5%. Simultaneously, PAT could enhance product yields, enable faster product time-to-market, and improve operational performance by increasing plant and process line key performance indicators (KPIs).

Employing the PAT principle of having a scientific understanding of how critical process parameters impact product quality attributes is fundamental to drive operational excellence programmes and lower the risk, as well as cost, of manufacturing. Despite these benefits, many companies are concerned about embracing PAT solutions for all aspects of the drug life cycle because of the potential risks at the different levels:

* Supply chain and business level--risks include excessive raw material inventory acquisition, storage or usage, throughput and product delivery time, and loss of product quality excellence.

* Programme or project activities at mid-management level--risks revolve around organizations because new cross-functional teams must be created, which could diminish other activities and cause personal relocation or dislocation.

* Project or plant level--risks include developing new complex process development techniques, operator training and capability enhancement. Operational excellence enables an organization to manufacture products to exact quality specifications in the shortest period of time, consume the least amount of resources possible, address regulatory requirements and satisfy customer demand. Goals will vary for each company depending on operating constraints, but referencing 'world class' benchmarks can provide insight as to what is possible.

Business level risks may cause companies to struggle in finding the best way to utilize PAT. A company may not have a clear manufacturing technology strategy or may possess a 'wait and see' attitude regarding PAT, or adopting PAT may involve undefined expenses. Management may also consider PAT initiatives as labour reduction exercises, which are counterproductive at all levels in the organization as labour reduction in terms of rationalization or downsizing may be perceived as a large risk by personnel. Additionally, PAT can cause a paradigm shift in an unprepared business. New personal skills and capabilities may be required to support Quality by Design (QbD) for new products or building quality into the manufacture of existing important drugs.

Organizations must be willing to make appropriate changes to benefit from utilizing PAT in any of the three areas presented by FDA: (1)

* Designing quality into new products.

* Designing quality into the processes for existing products.

* Maintaining cGMP operations throughout the manufacturing floor.

What are the risk factors at each of the operational management levels?

Mitigating risks

Global competition, rising costs, time-to-market constraints, governmental regulations, political pressures and supply chain management are driving companies to develop new products to meet market needs, and ensure product quality and patient safety, while also increasing shareholder value. Today's businesses require:

* Consistent quality conformance.

* Increased manufacturing KPI performance.

* Reduced product time-to-market.

* Comprehensive understanding of process and product quality relationships.

* Dynamic product life cycle management.

* Cost-effective process solutions investments.

* Ongoing regulatory compliance, implementing PAT programmes into process facilities can be challenging and may pose a risk to the business. Because new processes change the way operations are performed, there is an associated risk to product quality and regulatory compliance, implementing the proposed changes may, therefore, be met with some reluctance. Additionally, each business must keep existing operations running, continue to manufacture quality products and allocate resources for future projects. By considering the risks...

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