Pharmaceutical plants operate under tight timelines, strict standards, and high expectations for consistency. Yet many facilities struggle with recurring deviations, unpredictable batches, and constant rework that eats into already limited capacity. When every stage of production depends on precision, even small process shifts can create costly setbacks.

These issues rarely come from a lack of effort. They usually come from unstable processes, unclear operating conditions, and teams spending more time reacting than controlling the workflow. BMGI India works with pharmaceutical companies to stabilise processes, build discipline, and protect yield across critical operations.

Why pharma operations slip into instability

Pharma manufacturing combines complex chemistry, sensitive equipment, and human-driven steps. Without structured controls, variation creeps in faster than teams realise.

Typical patterns include:

• Operators running with slightly different settings
• Inconsistent material handling or mixing practices
• Poorly defined ranges for temperature or agitation speed
• Delays that extend beyond validated time windows
• Corrective actions that focus on symptoms instead of causes

Each small shift may seem harmless, but together they create deviations, failed batches, higher cost of quality, and loss of capacity that cannot be recovered.

How BMGI India helps stabilise performance

BMGI India applies Lean, Six Sigma, and operational excellence methods to help pharma plants get control of their processes. The work focuses on three priorities:

1. Reduce variation at the sourceTeams map critical steps, define operating windows clearly, and remove guesswork from instructions. Variation drops when people know exactly what conditions must be maintained.
2. Strengthen process disciplineVisual controls, standard work, and clear escalation paths help shift teams from firefighting to early detection. Problems get addressed before they turn into deviations.
3. Build data-driven decision makingInstead of relying on memory or past habits, teams use real performance data to understand where the process drifts and how to correct it.

Case study: recovering yield in a granulation process

A formulation plant faced recurring granulation failures that reduced batch yield and forced multiple reworks. Shift teams followed slightly different mixing speeds and binder addition rates, which created inconsistent moisture levels.

BMGI India helped the team study the process data and run a few small trials. They identified the optimal combination of mixing time and binder flow. Once these settings were standardised and displayed at the line, failures dropped sharply. The plant recovered hours of lost capacity each week and avoided unnecessary investigations.

What stabilised processes deliver

Once variation is controlled, results improve across the plant.

• Fewer deviations and repeat investigations
• More predictable batch cycle times
• Better yield with less waste
• Reduced stress on both production and quality teams
• Capacity that can be redirected to new products or higher volumes

These gains come from consistency, not shortcuts.

Building capability for long-term control

BMGI India supports capability building as part of the improvement journey. Teams learn how to analyse issues, run focused experiments, and maintain process stability without constant external support. Over time, the plant develops confidence in its ability to hold performance steady.

Conclusion

Deviations, batch failures, and rework are not just quality issues. They are signals that the process needs stronger control. Pharmaceutical plants that stabilise their processes protect yield, reduce investigation workload, and gain capacity without adding new equipment.

Source: https://bmgindia.weebly.com/blog/deviations-batch-failures-and-rework-are-draining-capacity-bmgi-india-helps-pharmaceutical-plants-stabilise-processes-and-protect-yield