Volume 23, Number 4

Table of Contents

Articles

Country Profile: Singapore - July/August 2003

by Singapore Affiliate
This section takes a look at the pharmaceutical industry in Singapore; produced in collaboration with ISPE Singapore.

An Information Based Approach to Validation

by Hosam Aleem, Stuart Lord, Tim McCarthy, Paul Sharratt, Yuyang Zhao
This article presents an Electronic Validation (eValid) project initiated by a research group at the University of Manchester Institute of Science and Technology (UMIST).

From Never to Forever: Document Retention Policy

by Mark Kropp
This article supports the writing of a document retention policy and gives general time retention periods for different kinds of documents including electronic copies. It outlines planning for retention and can be used when programming current compliance software packages.

Adopting a Risk - Based Approach to 21 CFR Part 11 Assessments

by Ken Phoenix, John Andrews
This article describes how to adopt a risk-based approach to 21 CFR Part 11 (Part 11) assessments for computer systems used for cGMP relevant activities within the pharmaceutical industry.

Biopharmaceutical Manufacturing Documentation

by Yong Wang
This article presents a process and operational documentation model for a typical biopharmaceutical manufacturing system. Eight important biopharmaceutical manufacturing documents and design documents are described and the relationship between documents is discussed.

Process Validation Acceptance Criteria for Solid Dosage Forms

by Pramote Cholayudth
This article introduces an acceptance criteria for process validation to assess the production batch under validation in terms of dosage uniformity.

Electronic Documentation - The Rewards of Information and Proactive Implementation

by Glen Schulz, Gerhard Werling
This article discusses the benefits of portal applications for centralizing critical electronic data, application requirements and essential features designed to support 21 CFR compliance.

Effective Standard Operating Procedures in a Regulatory Environment

by Erica Charlton
This article discusses the importance of Standard Operating Procedures (SOPs) in a regulatory environment and makes suggestions as to how to create, maintain, and circulate these documents in a manner compliant to worldwide regulatory agencies.

NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © ISPE. All rights reserved.)