Control strategy and QbD

Control strategy and QbD

TechTalk

Quality by Design - from patient to control strategy | TechTalk

Neglecting to develop a robust control strategy not only affects your business, but also holds severe consequences for the patient.

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3 key approaches to pharma manufacturing control strategy

With many considerations like the patient, GMP compliance and production, where do you begin when outlining a control strategy for pharma manufacturing?

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Establish a pharma manufacturing control strategy

A robust control strategy is a good manufacturing practice ‘must.’

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Increasing flexibility with control strategy | TechTalk

The key to manufacturing a consistent, quality product is the control strategy .

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Get to know pharma-focused Quality by Design (QbD) | TechTalk

QbD principles are still not the standard for all manufacturers’ pharmaceutical facility design. So why should the pharma industry take QbD more seriously?

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The value of control strategy for legacy products | TechTalk

  Step 1: Identify critical process parameters If you do not know your potential critical process parameters (CPPs) you simply cannot establish a robust controls strategy . The journey towards an optimized process and control strategy .   Step 3: Define control strategy In the third and final phase, the knowledge gained in steps 1 and 2 is utilized to devise the control strategy . Additionally, the control strategy defines how to react on CPIs...

Projects

Quality strategy for biopharmaceutical manufacturing

Samsung Biologics’s QbD pharmaceutical facility features a quality program designed by NNE.

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Statistical process control: is it the right business strategy for you?

Developing robust statistical process control (SPC) can do wonders for your quality control .

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Data-based road map to continuous control strategy and real-time release | TechTalk

Many pharmaceutical manufacturers strive for continued product verification, but there are many advantages to focusing on continuous process control instead. Ideally, it is best to have continuous process verification and control where process parameters are adjusted to keep processes on target. Figure 1: For each unit operation PIs that can predict CQA and CPPs that can control PIs shall be found and their relations established. It can also b...