January/February 2011

Theme: Risk Management and Quality Systems

Manuscripts Due: 4 Oct 2010
Publishes: 21 Jan 2011

Articles in this issue will include implementation of risk management and quality systems through the use of ASTM 2500, GAMP, Risk-MaPP, ICH Q9 and Q10 methodology and standards. Following the release of the much anticipated ISPE Baseline^® Guide, Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP), where principles are laid out for a scientific risk-based approach to managing the risk of cross contamination to achieve and maintain an appropriate balance between product quality and operator safety. Articles will include case studies of how companies implemented these principles and how regulatory bodies globally have reacted to this approach. Articles and case studies also will include risk management relating to laboratories, facilities, utilities, and R&D as well as cross contamination and operator exposure. Note: Will also feature 2010 FOYA winner.

March/April 2011

Theme: Disposables and Sterile Manufacturing

Manuscripts Due: 1 Nov 2010
Publishes: 18 Mar 2011

This issue will focus on Disposables. The use of single-use disposables is becoming a major factor in biotechnology manufacturing. The disposable issues of waste management and bulk refuse can be discussed. Focus on disposable technologies may include bag systems, filters, connectors, aseptic transfer, controlled freeze-thaw, tubing, and many other types of equipment for bioprocessing in single-use format.

May/June 2011

Theme: Green Pharma

Manuscripts Due: 3 Jan 2011
Publishes: 20 May 2011

This issue will cover environmental and energy issues as it relates to the pharmaceutical industry. Topics that may be covered include sustainability, LEED design, energy optimization and efficiency, waste reduction, disposables, manufacturing waste handling, recycling opportunities, and lessons learned from other industries.

July/August 2011

Theme: Computer and Control Systems

Manuscripts Due: 2 Mar 2011
Publishes: 22 Jul 2011

This issue will focus on computers and controls. The advent of sophisticated tools has depended on the usage and integration of computers, computerized systems, and control strategies to enhance production. Mechanisms for the automation of manufacturing are dependent of the data produced, archived, and retrieved. The Pharmaceutical and Biotechnology industry is more dependent on computers, data, and controls strategies than ever before. Articles can be focused on computers, computer validation, GAMP, CGMP, control schemes, MES, LIMS, data acquisition, data management, data warehousing, data integration, discernible computerized records, etc.

September/October 2011

Theme: Project Management and Operational Excellence

Manuscripts Due: 2 May 2011
Publishes: 23 Sep 2011

This issue will focus on Project Management and Operational Excellence. Effective implementation of Project Management and Operational Excellence programs and tools is an ongoing issue in which many organizations are focusing their efforts. Approaches, tools, case-studies and creative ideas can be shared in this issue. Project Management topics could include case studies of success projects, creative implementation of project management tools, project execution tools, organization of project management departments and processes or other aspects of the Project Management profession. Operational Excellence topics could range from instruction on the selection, implementation and use of measurement mechanisms and key process indicators to program-level subjects such as implementation of electronic batch records, six-sigma or other lean programs at a site, company or enterprise-wide level.

November/December 2011

Theme: Utilities

Manuscripts Due: 1 Jul 2011
Publishes: 21 Nov 2011

This issue will be centered on Critical Utilities used in Pharmaceutical and Biotechnology facilities. Innovations and new approaches are being instituted by reducing energy costs, minimizing carbon footprints, and consolidation of older systems. Integration and design with intrinsic usage of critical utilities complements the manufacturing environment. Articles can be submitted on pharmaceutical waters, gases, compressed air, electrical, cost savings, green usage, recycle, reclaim, and reuse of critical utilities.