Rational RevalidationCitation formats

Standard

Rational Revalidation. / Aleem, Hosam Abdel; McCarthy, T J; Edwards, Rodger.

In: Journal of validation Technology, Vol. 16, No. 2, 2010, p. 83-92.

Research output: Contribution to journalArticlepeer-review

Harvard

Aleem, HA, McCarthy, TJ & Edwards, R 2010, 'Rational Revalidation', Journal of validation Technology, vol. 16, no. 2, pp. 83-92.

APA

Aleem, H. A., McCarthy, T. J., & Edwards, R. (2010). Rational Revalidation. Journal of validation Technology, 16(2), 83-92.

Vancouver

Aleem HA, McCarthy TJ, Edwards R. Rational Revalidation. Journal of validation Technology. 2010;16(2):83-92.

Author

Aleem, Hosam Abdel ; McCarthy, T J ; Edwards, Rodger. / Rational Revalidation. In: Journal of validation Technology. 2010 ; Vol. 16, No. 2. pp. 83-92.

Bibtex

@article{cce5b420f82e48b09c9169c5d353f311,
title = "Rational Revalidation",
abstract = "The economic problems the world is currently facing have caused severe cost pressure on pharmaceutical manufacturing. Revalidation of manufacturing processes and equipment comprises a significant cost to the industry. Maintaining a validated status is a regulatory requirement. Technical issues, patient risk, and business considerations impact the organizational approach to revalidation. This discussion addresses the need for revalidation with particular attention to business considerations. Strategies to prioritise revalidation among systems and how to decide on what, how, and when to revalidate are discussed. Alternative approaches when revalidation is not possible are suggested. Costs associated with revalidation are described. Activities to reduce the need for revalidation including statistical process control are discussed. Business models for approaching revalidation including in-house and outsourcing are considered. Change management is a key component of a revalidation program. Also key is a structured approach to validation maintenance as time-based and eventbased. Considerations in these discussions do not compromise patient safety and product quality. Business factors only determine the order in which the systems are to be revalidated. Under no circumstances would the product of a manufacturing process that is not validated to regulatory expectations be released to the marketplace",
author = "Aleem, {Hosam Abdel} and McCarthy, {T J} and Rodger Edwards",
year = "2010",
language = "English",
volume = "16",
pages = "83--92",
journal = "JVT",
issn = "1079-6630",
publisher = "Advanstar Communications Incorporated",
number = "2",

}

RIS

TY - JOUR

T1 - Rational Revalidation

AU - Aleem, Hosam Abdel

AU - McCarthy, T J

AU - Edwards, Rodger

PY - 2010

Y1 - 2010

N2 - The economic problems the world is currently facing have caused severe cost pressure on pharmaceutical manufacturing. Revalidation of manufacturing processes and equipment comprises a significant cost to the industry. Maintaining a validated status is a regulatory requirement. Technical issues, patient risk, and business considerations impact the organizational approach to revalidation. This discussion addresses the need for revalidation with particular attention to business considerations. Strategies to prioritise revalidation among systems and how to decide on what, how, and when to revalidate are discussed. Alternative approaches when revalidation is not possible are suggested. Costs associated with revalidation are described. Activities to reduce the need for revalidation including statistical process control are discussed. Business models for approaching revalidation including in-house and outsourcing are considered. Change management is a key component of a revalidation program. Also key is a structured approach to validation maintenance as time-based and eventbased. Considerations in these discussions do not compromise patient safety and product quality. Business factors only determine the order in which the systems are to be revalidated. Under no circumstances would the product of a manufacturing process that is not validated to regulatory expectations be released to the marketplace

AB - The economic problems the world is currently facing have caused severe cost pressure on pharmaceutical manufacturing. Revalidation of manufacturing processes and equipment comprises a significant cost to the industry. Maintaining a validated status is a regulatory requirement. Technical issues, patient risk, and business considerations impact the organizational approach to revalidation. This discussion addresses the need for revalidation with particular attention to business considerations. Strategies to prioritise revalidation among systems and how to decide on what, how, and when to revalidate are discussed. Alternative approaches when revalidation is not possible are suggested. Costs associated with revalidation are described. Activities to reduce the need for revalidation including statistical process control are discussed. Business models for approaching revalidation including in-house and outsourcing are considered. Change management is a key component of a revalidation program. Also key is a structured approach to validation maintenance as time-based and eventbased. Considerations in these discussions do not compromise patient safety and product quality. Business factors only determine the order in which the systems are to be revalidated. Under no circumstances would the product of a manufacturing process that is not validated to regulatory expectations be released to the marketplace

M3 - Article

VL - 16

SP - 83

EP - 92

JO - JVT

JF - JVT

SN - 1079-6630

IS - 2

ER -