The industry of pharmaceutical manufacturing is all about controlling quality, increasing yield, and accelerating time to market. To achieve this level of manufacturing performance, are you asking the right questions? This blog addresses key questions pharma manufacturers must ask—and plan around—to achieve better overall performance.

At Applied Materials, we work closely with our pharma partners to use advanced manufactuing technologies to help deliver higher yields and faster time to market as Pharma 4.0 technology is increasingly widely adopted.

We identify the critical metrics to prioritize against including enhanced(e) Quality(Q), Yield(Y), Productivity(P), and accelerated time to market(t). To drive improvement through emerging pharma 4.0 manufacturing, we’ve adopted this eQYPt set of criteria to measure and optimize productivity.

Quality is the number one priority in pharma manufacturing due to the high saftey risk associated with the industry and the heavily regulated environment it operates in. Yield of manufacturing processes (batch or continuous) is prudent for improving operational margins and to respond to demand, while productivity improves supply chain resilency, time to market, and better return on capital employed (ROCE). To optimize a patient-centric focused outcome for pharma manufacturers, all three of these performance indicators must work in concert to accelerate time to market (t).

Figure 1. The eQYPt approach is focused on the most essential KPIs in pharma, including enhancing quality, yield, and productivity to accelerate time to market, where success depends on identifying the critical questions

By addressing the critical questions that pharma leaders are asking in each area of the eQYPt approach, we can build a digital strategy around the most essential KPIs in the industry (see Table 1)

Table 1. Questions that Pharma Leaders Are Asking

Quality-related Questions
  • Will automating “QC by Inspection” with vision systems reduce my labor costs and quality risk?
  • Can I improve quality adherence by employing Continuous improvement Process Verification (CiPV) to connect QC lab results with real-time data to improve process variability and understanding?
  • Can I minimize contamination risk by employing digital tools to alert for action?

Yield-related Questions
  • Can I use Continuous Process Verification (CPV) to boost my operating profit?
  • Is there a way for my process scientists and operators to collaborate in a single data-connected workspace to reduce batch failures?
  • Can I leverage my existing process data systems to reduce waste and improve overall equipment efficiency (OEE) and supply predictability?
Productivity-related Questions
  • Can I employ adaptive scheduling to optimize assets and other resources to satisfy production demands with significant improvements?
  • How do I improve return on capital employed (ROCE) and apply it across all my manufacturing plants?
  • If I improve my process variability, can I reduce my inventory costs?
Time-related Questions
  • Will the right design of experiment (DoE) platform reduce my process development time?
  • Can I integrate the data streams from a variety of process analytics technology (PAT) sensors and reduce my tech transfer and FDA approval time?
  • After I define critical process parameter (CPP) and critical process quality (CPQ) during development, can I transfer and verify them at manufacturing scale in less time?

In conclusion, success in today’s pharmaceutical climate depends on asking the right questions and building strategies around the most essential KPIs. These include enhancing Quality, Yield, and Productivity to accelerate time-to-market (eQYPt).

Ready to learn more about how SmartFactory Rx® solutions can help address these questions?

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