3. What is process validation and its sampling step by step

Question

Accepted Answer

Process validation is the process of ensuring that a process consistently produces a product that meets its specifications.

Process validation involves establishing documented evidence that a process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.
The sampling step involves selecting a representative sample of the product and testing it to ensure that it meets the predetermined specifications.
The sampling plan should be designed to ensure that the sample is representative of the entire batch or lot.
The sampling plan should also take into account the variability of the process and the critical quality attributes of the product.
Examples of process validation include validating the manufacturing process for a new drug, validating the sterilization process for medical devices, and validating the packaging process for food products.

Accepted Answer

Process validation is step by step procedure designed to ensure that a manufacturing processes can Cansistently procedure quality products.

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