|
A comparison of comprehensive third-party excipient GMP audit programs.
Oct 2, 2012
By:
Darcy Ewalt, Tracy L. Cooper, Frithjof Holtz, Irwin Silverstein, PhD
This article provides a comparison of Rx-360, EXCiPACT and IPEA, available to pharmaceutical manufacturers for the purpose of auditing excipient suppliers and ensuring drug efficacy and patient safety.
|
The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.
Mar 1, 2012
By:
Irwin Silverstein, PhD
The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.
|
A new audit guide aims to improve supply-chain security and supplier qualification practice.
Mar 2, 2011
By:
Irwin Silverstein, PhD
A new audit guide aims to improve supply-chain security and supplier qualification practice.
|
|
The author explains the background behind the excipient pedigree and how to implement its use.
Sep 1, 2010
By:
Irwin Silverstein, PhD
The author explains the background behind the excipient pedigree and how to implement its use.
|
|
The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.
May 1, 2010
By:
Irwin Silverstein, PhD
The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.
|
This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program.
Oct 2, 2009
By:
Irwin Silverstein, PhD
This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program.
|
IPEC's new stability testing guide takes into account the full supply chain's storage conditions.
Sep 2, 2009
By:
Philip H. Merrell, Irwin Silverstein, PhD
IPEC's new stability testing guide takes into account the full supply chain's storage conditions.
|
The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.
Oct 1, 2008
By:
Irwin Silverstein, PhD, Arthur Falk, Dale Carter, MS, Maria Guazzaroni Jacobs, David Schoneker
Securing the integrity of the excipient supply chain is a crucial task in ensuring the overall pharmaceutical supply chain. The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.
|
The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.
May 2, 2008
By:
Irwin Silverstein, PhD
The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.
|
|
