Articles by Irwin Silverstein, PhD - Pharmaceutical Technology

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Articles by Irwin Silverstein, PhD

Supplier Qualification

A comparison of comprehensive third-party excipient GMP audit programs.
Oct 2, 2012

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 American National Standard for Excipient GMP

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

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.

Inside IPEC: IPEC–Americas Releases Good Distribution Practices Audit Guide

A new audit guide aims to improve supply-chain security and supplier qualification practice.
Mar 2, 2011

A new audit guide aims to improve supply-chain security and supplier qualification practice.

Excipient Pedigree Verification

The author explains the background behind the excipient pedigree and how to implement its use.
Sep 1, 2010

The author explains the background behind the excipient pedigree and how to implement its use.

IPEA Excipient GMP Certification Program

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

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.

Technical Note: The Case for Supplier Qualification

This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program.
Oct 2, 2009

This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program.

Inside IPEC–Americas: Evaluating Excipient Stability

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.
Sep 2, 2009

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

Excipient-Control Strategies

The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.
Oct 1, 2008

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.

Inside IPEC–Americas: Excipient Audits and API Audits are Worlds Apart

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.
May 2, 2008

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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