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.

January/February 2010

Theme: Process Equipment and Systems

Manuscripts Due: 4 Sep 2009
Publishes: 22 Jan 2010

Articles in this issue could focus on process equipment and systems used in all types of pharmaceutical manufacturing facilities (such as oral solid dosage, biotech, parenteral, and medical devices). Potential articles could address the design, manufacturing, commissioning/qualification, maintenance, and other life cycle aspects of the equipment and systems used to manufacture drugs and medical devices.

Topics to include: design, installation, commissioning, C&Q, and use of the equipment, OSD, packaging, sterile equipment, filling lines, washing equipment, autoclaves, centrifuges, freeze-dryers.

March/April 2010

Theme: Facilities

Manuscripts Due: 3 Nov 2009
Publishes: 23 Mar 2009

Potential articles in this issue will focus on the design, construction, qualification, and operation of facilities in the pharmaceutical and biotechnology industries. Key focus points could range from green design and building techniques, future trends, effects of current regulatory trends, and facility considerations stemming from new technologies, such as disposable manufacturing and advancements in isolator/RABs technologies. Additional areas to address may include site master planning, innovative design processes, or construction techniques, commissioning/qualification/validation, the effect of global compliance strategies on facility design, facility cost and schedule benchmarking, and new techniques in project management.

Topics to include: design, installation, commissioning, C&Q, use and decommissioning of the facilities, including LEED, site selection/evaluation, material flow, and site master planning.

May/June 2010

Theme: Biotechnology

Manuscripts Due: 1 Jan 2010
Publishes: 21 May 2010

Articles in this issue could focus on current industry trends and issues in process development, equipment design, and manufacturing technology being found in the development and manufacture of human therapeutics from biotech processes. Topics can include discussions on new manufacturing technologies, compliance initiatives, challenges in technology transfer and process scale-up. Business impact issues, such as generic biologics, health care reform, and global competition could be addressed.

Topics to include: proteins, transgenomics/transgenetics, synthesis, upstream/downstream, inoculation, disposal and waste, gas transfer, chromatography, cell banks, fermenter/bioreactor design, vaccines.

July/August 2010

Theme: Quality and Regulatory Issues

Manuscripts Due: 2 Mar 2010
Publishes: 21 Jul 2010

As organizations strive for continuous improvement in a lean environment, global regulatory harmonization is a key objective for the pharmaceutical industry. Articles and case studies in this issue could address regulatory harmonization globally to influence change within the industry. Potential articles relevant to ISO revisions and how it relates to suppliers of the pharmaceutical and biotechnology manufacturing community also could be evaluated.

Topics to Include: current status of regulatory guidelines, such as ICH Q8, Q9, and Q10. PIC/S, 21 CFR Part 11, Annex revisions, EP, JP, and USP revisions.

September/October 2010

Theme: Maintenance

Manuscripts Due: 3 May 2010
Publishes: 22 Sep 2010

Articles in this issue could focus on trends and issues in managing and executing the maintenance of facilities and equipment in the pharmaceutical environment. New and innovated approaches, including on-line instrumentation, data acquisition and archiving along with risk management of the maintenance function with a focus on replacement or repair could be featured.

Topics to include: outsourcing vs. in-house support, the global impact, managing risk over the equipment/facility lifecycle, how to manage, who leads the outsourcing effort, and regulatory issues.

November/December 2010

Theme: Product Security

Manuscripts Due: 2 Jul 2010
Publishes: 22 Nov 2010

In times of tough economic challenges and changing regulations, the overall risks to the security of our products becomes increasingly critical. The integrity, availability, and branding of products are essential to the bottom line and ultimately your corporate reputation. This issue could focus on the risks and mechanisms for protection of your assets from a product integrity and compliance standpoint. Articles relevant to these topics include: counterfeiting, import/exporting, e-pedigree, biosimilars, RFID, supply chain security, product labeling, product identification, packaging/labeling, and the security of information and data surrounding these topics.

Topics to include: counterfeiting, e-pedigree, biosimilars, RFID, supply chain, product labeling, product identification, packaging/labeling, IT security of records.