FIP Announces IPS Medal Winner


Oct 04, 2012

Pharmaceutical Manufacturing

International Pharmaceutical Federation (FIP) has elected Dr. Ali Afnan from a series of worthy candidates to win its prestigious Industrial Pharmacy Medal 2012. Each year FIP's Industrial Pharmacy Section (IPS) presents its IPS medal to the pharmacist or scientist who has made an extraordinary contribution to the global pharmaceutical industry. Candidates are assessed based on the following criteria: influence and impact on industrial pharmacy developments beyond that of job responsibilities; contribution over an extended period or very high impact over a shorter period; international or national recognition; demonstrated leadership skills; demonstrated ability to build links with other branches of the profession (community, hospital, information, administrative pharmacy, etc.); and role model for young pharmacists.

On October 7, 2012, Afnan will be recognized for his achievements at the IPS Business Meeting at the Amsterdam FIP Centennial congress. Afnan will also give a 20 minute presentation on how he would like to see the industrial pharmacy evolve.

Afnan’s nomination was submitted by Emil W. Ciurczak, president of Doramaxx Consulting. According to Ciurczak, Afnan’s accomplishments include 10 years at AstraZeneca and three years at ICI just prior. While at ICI, he was a measurement and Control Engineer, On-line Measurement and Control Division. Here he learned his skills in on-line measurement and validation techniques for those methods. While at AstraZeneca he was a Senior Technologist, International Technology Development Group, Pharmaceutical Engineering where he plied what he learned. He worked to engage the company in PAT long before the PAT Guidance was developed by the USFDA. He worked with FDA, MHRA and EMA to perform feasibility studies, specify equipment and implement PAT. While there he also built an entire solid dosage form process facility in Germany, controlled by Near-Infrared instrumentation. To do this he had to redefine all the concepts of critical aspects of production, changing a 1950s paradigm to a 21st century method of production.

The project included Afnan designing the analytical instrumentation, overseeing its construction, validation documentation, and its installation and commissioning. He designed specification of the data management structure; interfaces; hardware/ software modules; data hierarchy; specification and design of regulatory, compliance, quality and manufacturing data interfaces; defining data archiving principles and practices. This was the first such facility implemented within AstraZeneca and is believed to have been the first in the pharmaceutical industry.

While at the USFDA, [first as: Visiting Scientist, PAT Policy Team (2003 - 2008), Office of Pharmaceutical Science (CDER); later as Senior Staff Fellow, Science and Policy Advisor to Director (2008 - 2010), Office of Pharmaceutical Science (CDER)], he worked on the PAT Guidance, helped develop the FDA initiatives on, for example, the Process Validation Guidance. Afnan represented the Office at industrial, trade associations, and internal FDA meetings. Other responsibilities at FDA included:

1. Senior member of PAT core policy team and co-author of the 2004 PAT Guidance;

2. Member of team drafting the quality (QbD) and Question based review (QbR);

3. Member of team drafting the process validation Guidance and associated policies;

4. Helped establish collaboration with non-CDER centers;

5. Helped establish training programs for drug application reviewers and investigators charged with inspecting pharmaceutical manufacturing facilities;

6. Facilitated submission of New, Generic, and Biotechnology PAT applications;

7. Aided in mentoring and training of staff assigned to review and inspection PAT submissions;

8. Helped coordinate discussions with industry and other regulatory Agencies; working with consensus standards organizations;

9. Helped coordinate interactions and research ventures with international academic institutions and organizations supporting the advancement of pharmaceutical sciences.

Since leaving the Agency, Afnan has spoken, consulted and taught courses around the world on improving the quality of pharmaceutical products. He continues to establish QbD/PAT programs at companies around the world and is an outspoken voice for excellence in the pharmaceutical industry.