The Global Information Source for
Pharmaceutical Manufacturing Professionals

2008  Editorial Calendar

January/February 2008 Theme: Critical Utilities (water, steam, gases), HVAC Manuscripts Due: 4 September 2007 Publishes: 21 January 2008 Potential articles in this issue will emphasize the changing roles and centrality of the critical utilities of water, steam, and gases in pharmaceutical production. Topics could address automation, computerization, IT, process control, and the flow and administration of critical utilities, computer verification, continual quality verification systems, and statistical process control, globalization of pharmaceutical manufacturing facilities with global networking, and global monitoring.

March/April 2008 Theme: Facility Design Manuscripts Due: 2 November 2007 Publishes: 20 March 2008 Potential articles in this issue will focus on the design of pharmaceutical, biotech, and filling facilities in the ever changing markets and regulatory environments. Key focus points could range from Green Building techniques, green processing (LEED), future trends, disposable manufacturing, design process from site master planning through facility design qualification/validation, renovation and retrofitting, design space, RFID, the effect of global compliance strategies on facility design, facility cost and schedule benchmarking, and new techniques in project management.

May/June 2008 Theme: Risk Assessment and Management Manuscripts Due: 4 January 2008 Publishes: 20 May 2008 Potential articles in this issue will focus on Risk Management and its applications in the pharmaceutical industry, including interpretation and case studies on ICH Q8, Q9, and Q10 as well as Quality by Design applications and why the ISPE C&Q Baseline Guide was revised to align with the new risk-based approaches. Articles on the new Risk-MaPP ISPE Baseline Guide and its application of ICH Q9 in setting cross contamination limits will also be included. Articles could also investigate how to effectively manage the Risk Management process, PAT application, process control strategy, and design space.

July/August 2008 Theme: Process Development Manuscripts Due: 3 March 2008 Publishes: 21 July 2008 Potential articles in this issue will focus on process development topics, including process research and innovation, process modeling, scale-up, and the design, construction, and operation of pilot plants and laboratory units. This issue could explore technology transfer, manufacturing optimization, operational excellence, and the use of PAT to achieve new efficiencies and increase process knowledge and control. Additional topics could include design space, combined products, continuous processing, ICH Q8, Q9, Q10, Quality by Design, and fast response facilities.

September/October 2008 Theme: Oral Solid Dosage (OSD) Manuscripts Due: 2 May 2008 Publishes: 22 September 2008 Potential articles in this issue will focus on the processes and equipment used in a typical Oral Solid Dosage (OSD) facility. Case studies will attempt to demonstrate PAT application, better process control strategies, and automation in an OSD environment. Articles featuring the latest in OSD packaging technology, including robotics, RFID, and vision systems will be sought. Additional topics could include advancements in combined products, production, tabletting, containment, and risk assessment. An update and application of the ISPE Baseline Guide will be featured.

November/December 2008 Theme: Decontamination/Containment/Sterilization Manuscripts Due: 3 July 2008 Publishes: 20 November 2008 Potential articles in this issue will focus on the latest in Decontamination/Containment/Sterilization technologies and their applications in the pharmaceutical industry. Case studies could explore how these systems are incorporated into pharmaceutical processes and facilities. Additional topics could focus on how to effectively utilize a Risk Management process to determine the decontamination/containment/sterilization needs, in addition to sampling issues, aseptic sampling, cleaning, PAT application, and process control strategy. Articles on the newly updated ISPE Baseline Guide for Sterile Manufacturing Facilities as well as updates and applications of various ISPE technical documents, including the Water and Steam Baseline Guide Revision, HVAC Good Practice Guide, and the C&Q of Pharmaceutical Water and Steam Systems Good Practice Guide will be featured.