Automation, Process Control and IT Systems
Publishes: 17 July 2013
This issue includes articles celebrating the 21st anniversary of GAMP® - ISPE’s world-renowned industry guidance on the regulation and use of automated systems in the pharmaceutical industry. Other topics include FDA regulations of computer systems in drug manufacturing; compliant cloud computing; and an article on GMPs for Halal (prepared in the manner prescribed by Islamic law) pharmaceuticals.
There are publishing opportunities still available for 2013. For more information, visit the "Submit Article" page.
What topics would you like to read or write about in Pharmaceutical Engineering?
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Cover Story/Lead Article: Biotechnology, Biosimilars, Large Molecule, Single-Use
|Manuscripts Due: 1 Oct 2012||Publishes: 16 Jan 2013|
|Specific topics could include: biosimilars, large molecule, single-use technologies, buffers fermentation separations centrifugation, microbial, human/mammalian cells, protein, waste management, and global regulatory implications.|
Cover Story/Lead Article: Project Management
|Manuscripts Due: 2 Nov 2012||Publishes: 20 Mar 2013|
|Specific topics could include: professional development, training, team building, leadership training/tools, career path development, construction management, case studies for construction projects, compliance/remediation, software tools, Build-Own-Operate (BOO), and Building Information Management (BIM).|
Cover Story/Lead Article: Clinical Manufacturing
|Manuscripts Due: 2 Jan 2013||Publishes: 15 May 2013|
|Specific topics could include: Investigational products, supply chain, clinical supplies, tech transfer, regulatory implications (PQLI), scale-up, process verification, impact on PPQ, selection of a CMO, and comparator studies.|
Cover Story/Lead Article: Automation, Process Control and IT Systems
|Manuscripts Due: 4 Mar 2013||Publishes: 17 Jul 2013|
|Specific topics could include: cloud, information systems, automated processes, data management, data archiving, MES, LIMS, and VPCS/GAMP Guides.|
Cover Story/Lead Article: Sustainability and Green Manufacturing
|Manuscripts Due: 6 May 2013||Publishes: 18 Sep 2013|
|Specific topics could include: LEEDs, packaging considerations, paperless documentation, waste management, carbon footprint offsets and reductions, energy audits, airborne emissions, best practices, and case studies by site/by company.|
Cover Story/Lead Article: Cleaning, Sanitization, and Sterilization
|Manuscripts Due: 5 July 2013||Publishes: 13 Nov 2013|
|Specific topics could include: alternatives to SIP, CIP, autoclaves, single-use technologies, ozone, case study on Sterile revision, regulatory summary onUS FDA vs. EU approach to sterile processing (example: room classification, autoclaves),and different regulatory approaches based on US vs. EU manufacturing.|