ISPE Update: “Update on the CPIP Credential”
This session will provide an update on the ISPE CPIP global credential programme for pharmaceutical professionals
Steve Williams, Chairman, ISPE CPIP Commission & Director, Seerpharma Pty Ltd

Regulatory Keynote:
“Quality Risk Management and Knowledge Management in a Regulatory Setting”
Sound practice of risk management relies on data and information that can inform specific risk management decisions. This session will outline the complementary and, oftentimes, overlapping systems of risk and knowledge management. Quality risk management (QRM) cannot be accomplished in a knowledge vacuum; and, a portfolio of knowledge management projects can be prioritized using QRM approaches.
Dr. Gregg Claycamp, PhD, Director, Division of Compliance Risk Management and Surveillance, Centre for Drug Evaluation & Research, Office of Compliance, Food & Drug Administration

• Setting up an effective maintenance system
  
  
• “Maintenance Strategies At Inception of Greenfield Project”
  Goh Yong Keng,
  Director, Engineering and Maintenance, Schering Plough
  
  
• “Preventive to Predictive Maintenance Strategies” Lee Chin Hoo,
  Director, Engineering and Maintenance, Pfizer, Asia Pacific
  
  
• “Maintenance Strategies for Secondary Facilities”
  Ong Chin Teck,
  Director for Engineering, MSD

• “Site Master Planning”
  Site master planning is usually an integral part of the conceptual design study which identifies the key technical solutions, layouts, approximate cost and schedule of the project. This presentation identifieshow the Site Master Plan provides key information to support these objectives, describes a generic approach to its development and identifies some typical master Plan options currently practiced. Dr. Michael Brocklebank, Manager, Pharma Division, Foster-Wheeler Eastern Pte Ltd
  
  
• “Project Planning – An Integrated Approach”
  Session will address the requirement for early identification of critical permitting and regulatory approvals, integration of the design procurement and construction schedule stressing the importance of early identification of the required commissioning, qualification and system turnover requirements. This will be done reference to the ISPE baseline guide on C&Q and ASTM E2500 and reduction to project timelines by leveraging this approach.
  Damian Thornton,
  Vice President & Director Europe & Asia, Manufacturing and Life Sciences, CH2M Hill
  
  
• “Modular Construction - Addressing the Needs of the Bio-Pharmaceutical Industry in Singapore”
  This presentation will focus on modular construction’s application to the biopharmaceutical industry in Singapore, with insights to the benefits of this construction technology, lessons learnt from various biopharmaceutical construction projects and new approaches to modular construction.
  Paul Hochi,
  Manager of Project Development, Jacobs Applied Technology Inc., USA

• “An Integrated Approach to Commissioning & Qualification”
  Driven by the ever decreasing project timelines coupled with the pressures to expedite our product to market, the Pharma and Biotech industry is currently and continuously seeking new and innovative ways, without compromising quality, to deliver under budget and ahead of Schedule. All aspects to EPCMV are exposed to this challenge and in recent years, in particular, the Commissioning and Qualification process has and continues to undergo a metamorphosis. This session will aim to provide an insight into the evolving process of Integrated Commissioning and Qualification, ICQ, CQ, C&Q or Leveraged Commissioning and the challenges and possible solutions ahead.
  Lawrence Smiddy, Commissioning and Qualification Manager, GSK Biologicals
  
  
• “A Case Study of How Quality by Design (QbD) Principles Are Used In A New Chemical Entity Project”
  GSK has developed a concept which is aligned to FDA’s QbyD initiative; the intent of which is to enable development of well understood and robust manufacturing processes for New Chemical Entities (NCEs) by first intent based on good scientific understanding and sound risk management. This concept has revolutionized a wide spectrum of aspects such as process development, quality management system, regulatory submission approach and technology transfer. The presentation outlines how GSK has used this concept on an NCE.
  Clarence Wong,
  Technical Development Manager, GSK

• “A Comprehensive Approach to the Facilities and Equipment Subsystem of QSIT”
  This presentation will discuss the different system options for a comprehensive approach to the Facilities and Equipment Subsystem of QSIT and provide some guidance on how to choose the option that is most appropriate for each company.
  Bryce Johannes,
  Director of Marketing,
  Blue Mountain Quality Resources, Inc., USA

In the Jurong R&D pilot plant, most of the drugs that we are working on are destined for commercial scale production in Jurong GMS. Our proximity ensures the seamless transfer of process knowledge from Research and Development to Global Manufacturing and Supply which allows for optimum manufacturing efficiency, reinforcing GlaxoSmithkline’s continued commitment in making high quality and affordable drugs to help patients worldwide lead longer and healthier lives.

The facility consists of a general purpose Organic Synthesis Plant (OSP) and all the supporting facilities such as warehouse, dispensary, engineering maintenance and stores facility, utilities plant, solvent tank farm and solvent recovery area, drum storage, wastewater treatment plant, quality control laboratory, administration and cafeteria building. The facility is fully automated, using an advanced process control system.

The plant has a number of facilities that contribute to protecting the natural environment, including solvent recovery systems, a wastewater treatment plant and a regenerative thermal oxidizer, all designed to
conserve resources or minimize waste.

In October 2007, a 12 month project to construct a trigeneration plant on site was completed. This first-of-its-kind facility in Singapore was developed and built by Tuas Power and Gas Supply Green Energy Pte Ltd under a partnership with Pfizer Asia Pacific. It is capable of generating 4.6MW of power and up to 12 ton/hr of steam. The natural gas-fired facility will cut annual utility costs by US$ 500K and reduce carbon dioxide emissions by 6000 ton/yr (17%).

Located at a 20 hectare site at Singapore Tuas Biomedical Park, the manufacturing facilities of MSD Singapore comprise of a bulk active pharmaceutical ingredient (API) plant and a pharmaceutical formulation plant.

The API plant is a flexible and multi-product operation capable of producing various APIs including etoricoxib, an active ingredient for Arcoxia®, and simvistatin, an ingredient for Zorco® and Vytorin®. The pharmaceutical formulation plant is a tableting operation producing Vytorin®.

Since 1995, Schering-Plough has leveraged Singapore’s solid infrastructure, skilled workforce and pro-business environment to expand to its current six manufacturing facilities, producing a range of key active pharmaceutical ingredients, as well as finished drug products.

Schering-Plough is the first pharmaceutical company to set up an R&D pilot plant in Singapore which is also its first in the Asia-Pacific Region, a testament to the nation’s commitment to research and the robust intellectual property regime that has been put in place here.

The production focus will be on growth products, in line with the TechOps capacity optimization strategy. Investment of approximately USD 180 million will provide production capacity for 3.5 billions units (tablets), with the potential for expansion after 2008 to 6 billion units (or 20% of the overall solids manufacturing capacity in Pharma).