Wow! The workshop on Commissioning & Qualification (C&Q) at the Interphex workshop yesterday was really power packed! With the knowledgable Dr. Alice Redmond and experienced Robert Steen and Joe Eades, we were fed with all the current practices of C&Q. Robert even gave clear examples on C&Q of compressed air and water.

It seems that current practices of C&Q adopt the ASTM E2500-07 and ISPE CQ Baseline guide. This makes planning and pre-drafting of requirements and tests required as a priority. Some also adopt guidance from ICH Q8R. Most still stick to the traditional method via the V-model. An interesting point is the increasing use of risk assessment as a tool to pre-analysis and target only the critical issues, and identifying the Critical Process Parameters (CPP) and the Critical Quality Attributes (CQA) to be used in the conduct of C&Q.

As I said, it was fully loaded with facts. The breakout sessions give us opportunity to further understand and grasp the understanding of the concepts delivered.

How I wish we in Malaysia will soon have our own ISPE affiliates and organize such educational programs for the benefits of our own local colleagues in the pharma industry.
[Note: Sh. Fauziah & Samsinar of Idama Pharma is heading this and let’s hope this Malaysia Affiliate will materialize in due time. Please give themk your support.....].

AJ.