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”.
- 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.
Review the situation and understand the objectives
Validation process improvement:
Uncover process gaps and set up for improved collaboration
Understand the potential for improvements & implement sound practices
Statistical tools, simulations, experimental approaches, value stream implementation tools
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.
Risk-based process validation requires method deployment on a new level
Get in touch with our expert for methods in Process Validation
+49 171 644 59 04