Validating sampling plans

Posted by / 16-Dec-2017 08:40

Validating sampling plans

Generally, the use of RTR testing will include more extensive on-line/in-line measurement.A scientifically sound sampling approach should be developed, justified, and implemented.

A6: No, traditional sampling plans for in-process and end-product testing involve a discrete sample size that represents the minimal sampling expectations.Areas of poor blending must be covered in sampling.Corners and discharge point must have sampling location.Additional information is usually generated at this time including generation of a recommended spare parts list and maintenance schedule.Without proper installation of the equipment and supporting systems, operational and performance qualifications will not yield accurate information which can be used to document consistent and predictable performance.

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Sampling activities include clinical trials, formulation, stability (long term and accelerated), process characterization, analytical method development, method validation, process validation, and release testing.

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