January/February 2009

Theme: Innovative Technology
Country Profile: China

Manuscripts Due: 3 Sep 2008
Publishes: 21 Jan 2009

This issue will focus on the latest trends and innovations in the pharmaceutical and biotechnology industry, including new manufacturing and packaging methods; disposables; cleaning and sterilization; facility and process design; environmental detection; new instrumentation; and analytical methods in laboratories.

March/April 2009

Theme: Automation Solutions/PAT/Operational Excellence

Manuscripts Due: 4 Nov 2008
Publishes: 23 Mar 2009

Articles in this issue will focus on the automation solutions utilized in manufacturing, laboratory processes, operational excellence, and PAT. Topics include theoretical and practical applications of automation, including electronic batch record management, data warehousing, asset management, infrastructure monitoring, process data monitoring, and business process metrics.

May/June 2009

Theme: Regulatory – PQLI

Manuscripts Due: 2 Jan 2009
Publishes: 22 May 2009

Achieving global regulatory harmonization is a key objective for the pharmaceutical and biotechnology manufacturing community. Articles in this issue will address important topics influencing change in the industry, including the current status and interpretation of ICH Q8, Q9, and Q10; progress on ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative; USP, EP, and JP; consensus standards such as ASTM E55, BPE, and ISO; function and organization of regulatory bodies; and the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

July/August 2009

Theme: Utilities

Manuscripts Due: 2 Mar 2009
Publishes: 21 Jul 2009

Utility systems will be featured with case studies, new technologies, and current industry standards and guidance. Topics may include critical utilities supporting production, non-critical systems (such as electricity), energy and resource management, green initiatives, and energy efficiency. Also featured may be computer, remote and local monitoring systems commonly used in utility systems.

September/October 2009

Theme: Management of Globalization

Manuscripts Due: 1 May 2009
Publishes: 21 Sep 2009

Articles and case studies will focus on issues facing global manufacturing and distribution, such as quality standards, harmonization, outsourcing, logistics/supply chain issues, management of a diverse workforce, integration of equipment from global suppliers, and life cycle management of equipment from global suppliers.

November/December 2009

Theme:  Integrated Commissioning and Qualification

Manuscripts Due: 2 Jul 2009
Publishes: 20 Nov 2009

Articles in this issue will address opportunities to streamline and/or integrate commissioning and qualification utilizing recently issued guides, standards, and technologies. Case studies describing successful implementation of the integrated approach will be provided. Other tools to reduce qualification cycle time, such as risk assessment, will be covered.