Overview of the recent FDA Process Validation Guidance for Medicinal Product Development and Manufacture

Nuala Calnan

doi:10.21427/9fsc-ye52

Overview of the recent FDA Process Validation Guidance for Medicinal Product Development and Manufacture

Nuala Calnan

Graduate Business School

Research output: Contribution to conference › Paper › peer-review

Abstract

This conference paper presents an overview of the recently published FDA Process Validation Guideline for the development and manufacture of medicinal drug products. It discusses the impacts of conducting life cycle based validation activities and highlights the future challenges in meeting the ongoing 'Continued Process Validation' (CPV) expectations of the regulator. It also presents the latest information on the EU draft Process Validation Guidance - due for publication in late 2013 / 2014.

Original language	English
DOIs	https://doi.org/10.21427/9fsc-ye52
Publication status	Published - 2013
Event	PDA Ireland Symposium - Duration: 7 Jun 2013 → 7 Jun 2013

Conference

Conference	PDA Ireland Symposium
Period	7/06/13 → 7/06/13
Other	Embracing the Challenges of Lifecycle Based Validation

Keywords

FDA Process Validation Guideline
medicinal drug products
life cycle based validation
Continued Process Validation
EU draft Process Validation Guidance

Access to Document

10.21427/9fsc-ye52Licence: CC BY-NC-SA

Cite this

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title = "Overview of the recent FDA Process Validation Guidance for Medicinal Product Development and Manufacture",

abstract = "This conference paper presents an overview of the recently published FDA Process Validation Guideline for the development and manufacture of medicinal drug products. It discusses the impacts of conducting life cycle based validation activities and highlights the future challenges in meeting the ongoing 'Continued Process Validation' (CPV) expectations of the regulator. It also presents the latest information on the EU draft Process Validation Guidance - due for publication in late 2013 / 2014.",

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AB - This conference paper presents an overview of the recently published FDA Process Validation Guideline for the development and manufacture of medicinal drug products. It discusses the impacts of conducting life cycle based validation activities and highlights the future challenges in meeting the ongoing 'Continued Process Validation' (CPV) expectations of the regulator. It also presents the latest information on the EU draft Process Validation Guidance - due for publication in late 2013 / 2014.

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KW - Continued Process Validation

KW - EU draft Process Validation Guidance

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Overview of the recent FDA Process Validation Guidance for Medicinal Product Development and Manufacture

Abstract

Conference

Keywords

Access to Document

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Cite this