Monday 18^th - Tuesday 19^th October 2010

Siam City Hotel, Bangkok

FactoryTalk provided the main input into the design and running of a ISPE practical 2 day course to provide information for design companies, contracting companies, construction companies and owners and engineers from pharmaceutical companies about how to run a project to build a new oral solid dose (OSD) facility to meet PICS regulations and to use industry best practice (based on ISPE publications)

Ms. Sorada, ISPE Thailand president presented the gift to Mr. Paiboon, Thai FDA for his support.

The seminar focused on case studies on manufacture of oral solid forms with Low to Moderate Active Pharmaceutical Ingredients. This type of plant is probably the most common in Thailand and a number of companies are planning to build new plants.

Mr. Soon Eng Guan, Foster Wheelers Singapore was coaching the group on their assignment.

The participants found the event very useful input for their jobs, the main objective was achieved,  the objective to provide more practical information about the following :-

Project Management - Customer and Supplier relationships - responsibilities and activities of the pharmaceutical company and responsibilities and activities provided by the design companies, contracting companies, construction companies

The Vision - Case studies describe what a suitable plant might look like based on a typical OSD process consisting of : dispense, wet granulation, fluid bed drying, compression,

User requirements - Developing the key user requirements for the plant to meet production and regulatory requirements covering the product/process, room/facility & systems, including contamination control, critical utilities, processing equipment and control systems.

Risk Assessment - Introduce the concept of system impact to manage qualification

The Design Phase - Design Reviews - the importance of key design reviews leading to an approved design. Examples of key design points covering the building, HVAC, critical utilities, processing equipment and control systems.

The Commissioning Phase - use of the correct documentation, concept of Good Engineering Practice, Testing, IQ, OQ, PQ - what to test and record

The workshop exercises really helped to reinforce the key messages and included a real clean room and HVAC air handling unit, The opportunity to see and discuss real equipment provided a valuable addition to the workshop sessions.

Special thanks to our overseas visitors, they provide a big help for the audience to see how companies outside Thailand are working.