PROCESS VALIDATION

Validated Processes in Pharma & Medical

Quality integrated into the processes using the right tools

Why? Too often customers get their deliveries late, some batches are written off, and so much time and effort is wasted due to deviations. What an opportunity for improvement. Only with sanely validated processes are products consistently safe.

So, does that mean you should put more resources into validation? Explain on more paper that it’s good as it is developed? Conduct longer studies to obtain more data?

Of course, the answer to all the questions above is “no”. Anticipating more challenges to your validation documentation according to GMP by FDA, EMA, or other authorities is realistic and to be expected.

Can a seamless cross-functional effort of Quality Management, Quality Assurance, Process Development, MS&T, Sourcing, and Supplier Qualification be even better and faster? Our answer is a clear “yes”.

We support:

  • Implementing seamless cooperation and high involvement of people
  • Building your knowledge base on statistical methods

    and adapting methods to what is practical

  • Defining optimum process parameter settings and controlling the processes with appropriate measurement systems and sample sizes
  • Implementing risk assessments that are reliable for parametric validation in production.

Last but not least, methods are valid only if everyone sticks to the rules. Here we build on proven Lean tools to put this into practice.

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Preparation:

Review the situation and understand the objectives

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Validation process improvement:

Uncover process gaps and set up for improved collaboration

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Statistical approaches:

Understand the potential for improvements & implement sound practices

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Trainings:

Statistical tools, simulations, experimental approaches, value stream implementation tools

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Performance Management:

Set up sustainable systems, drive the improvement

Exchange with others on Capable Processes:

ONLINE ROUNDTABLE CAPABLE PROCESSES

Safe Quality through valid processes and smart statistics

April 29 2021, 15:00-17:30 CET

Learn more: Roundtable Capable Processes

Process Validation in Pharma: Results from our Roundtable discussion

Does this also apply to validation batches? Starting point of our roundtable: The traditional three batches for validation is often too many and sometimes too few. The discussion around the traditional three batches is the tip of the iceberg.

read more

Risk-based process validation requires method deployment on a new level

Every day in the operational business, problems are dealt with which relate to process validation. For example: Recurring high efforts resolving these.

read more

Get in touch with our expert for methods in Process Validation
 

ANDREAS KLEINERT
Andreas.Kleinert@oConsulting.com
+49 171 644 59 04