Module 3 2019

Validation Prior to Registration Studies

• Validation of methodology should be essentially complete to ICH standards prior to registration (ICH/VICH) studies

• One exception may be intermediate precision if the studies are being done in- house

• These studies represent a high business cost for your company

• Both in terms of up-front cost and critical path timing

• Jeopardising these because of faulty methodology must be avoided at all costs

•

Expect to repeat tests to higher standards

• e.g. perform spiking experiments to assess accuracy

• Ensure that the validation actually supports what you will claim

• Ensure that your linearity range incorporates all quoted results (e.g. DL to 2 x specification level for impurities)

• Ensure that accuracy/precision support the specification limit and LOQ

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