8 Rules for Drug Manufacturing

“A fast-changing environment and slow-changing species can only lead to one thing—extinction.”

          Claus Weisemann,
          VP Quality & Regulatory Compliance
          Grifols Biologicals

Weisemann should know, having seen the drug industry from myriad positions and companies over a long career. As such, he has developed a set of rules for moving manufacturing forward, from production to quality testing, as following:

The 8 rules:

1. Use science to drive everything we do.

2. But we still need to build a business case.

3. Quality, compliance, and effective manufacturing are compatible.

4. Build coalitions, on all levels of the organization.

5. If you can’t move in big steps, move in small steps.

6. Institutionalize your change—write it in SOPs, performance evaluations, etc. (It has an amazing magic to get things done!)

7. Use the historical—“tribal”—knowledge in your facility.

8. Eliminate the “language barrier” between automation/IT and other professionals.

(Source: “ 8 Rules for Drug Manufacturing” │Posted by Paul Thomas │Oct. 8, 2010)