19th May 2010

Time:  9:00-16:30

Piyarom Sport Club, Bangkok, Thailand

A number of Pharmaceutical Companies here in Thailand are planning new facilities or refurbishment projects. New facilities are normally provided by construction firms as turn-key projects. This involves delivery of management, design, construction, installation and commissioning services. It is therefore timely to keep up to date with best practice, new requirements and industry trends.

Agenda

• Recent GMP requirements
  Our GMPs continually evolve and develop. It is very important that we keep ourselves fully updated. In response to the revision of Annex 1 of the PIC/S GMP, a number of important issues have arisen that have needed clarification and explanation. To help inspectors and industry, PIC/S has recently published a document providing guidance on interpretation of some of these changes. We will review this guidance document to understand what it says and the impact.
  • PIC/S Annex 1 Interpretation guidance (published February 2010) - overview of the scope and impact of this?
  • Particle monitoring systems.
  • Grade A air supply for vial capping.

• Energy saving & sustainability considerations workshop---is there a conflict with our GMPs?
  This is a high profile subject these days as we strive to meet greenhouse gas targets, and perhaps more immediately reduce our energy consumption to save money.
  This workshop session will explore ways we might consider to achieve these objectives and see if they are GMP compatible. We will consider volume set-back, temperature reductions, and so on.
  • HVAC for sterile products.
  • HVAC for non-sterile products.
  • Pharma water systems.

• Containment and segregation.
  It has been clear for a long time that Beta-lactams need to be separated from other product families. However the extent of separation isn't clear when we consider hormones or other highly active molecules. Do we need separate buildings, segregated departments, or just dedicated equipment? We will look at the requirements, critical issues, and best practice.
  • What our cGMPs say.
  • Current Practice for Potent compounds.
  • ISPE's guidance on "Assessing the Containment Performance of Pharmaceutical Equipment".
  • Segregation techniques - Rooms and Isolators.

Seminar Speaker (The presentation will be in English)

Mr. Gordon Farquharson, Critical Systems Ltd.

Workshop Feedback

Facility Design & Operation for Compliant Pharmaceutical Manufacture workshop attended by 37 paticipants from 25 leading pharmacurtical companies in Thailand. According to the chart above, 69% of the participants found that the workshop is about what they expected and only 4% thought that it is some what dissappointed.