Validation has been a regulatory requirement in the pharmaceutical sector for many years

Validation has been a regulatory requirement in the pharmaceutical sector for many years. Explain how validation has been of benefit to the sector and how it can be used to improve quality, reduce defects and to make an organization more efficient.
As per Annex 15, an organization can take 2 different approaches to validate their processes- the traditional route or the enhanced route. There is also the option of using a hybrid approach. Discuss these approaches and how an organization might apply them to validate a new pharmaceutical process.

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