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A client recently wrote: "We are seeking validated information proving that a change in manufacturing procedure will provide a product that is equal to or superior to that supplied previously.

Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle. This presentation has been prepared from material available from FDA , EMA and ICH for beginners to have an overview of the new paradigm.The earlier guidelines were developed before the elaboration of the new ICH guidelines.With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches.The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria.ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy.




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