12.05.2014 |

LOGFILE No. 22/2013 - PDA/FDA Joint Conference

What is the Future Interpretation of GMPs?

By Thomas Peither

What is the future of good manufacturing practices (GMPs)? Why should pharmaceutical industry consider significant changes when it comes to performing quality principles?

At the PDA/FDA Joint Regulatory Conference 2013 in Washington approximately 70 speakers from the FDA and industry discussed FDA’s interpretations of current GMP regulations. The three session tracks “Quality and Compliance”, “Innovation and Technology” and “Product Lifecyle” covered different views and scopes of GMPs and provided insight into FDA’s current thinking on various topics. More than 800 participants showed a great interest in the presentations. Once again, the conference in Washington was a great success.

Quality is more than GMP

The presentations indicate that over the past years a paradigm change has occured. There are significant changes how quality departments should interpret cGMPs. Janet Woodcock from the  FDA, started with the statement that ”Quality culture is a key, a key to success and efficiency“. The industry speaker Janet Stevens, Hospira, demonstrated that pharmaceutical industry understood the paradigm change as well: „Change the mindset – change the behaviour“ was one of her key learnings from the implementation of culture changes in her organisation. In her presentation “How to Implement Quality Culture Across Multiple Sites“ she pointed out that quality should be priority #1 and cultural change will only be possible if you can illustrate it with positive stories to those affected. Positive stories are rewarded at Hospira. Her final advice: You have to take a realistic look at your organisation, as cultural change is a long journey that needs continuous communication. That being said, as a reward a competitive advantage waits at the end.

Mary Oates, Pfizer, provided insights into her experiences with quality change. “Compliance is the foundation and while it enables quality performance, it does not guarantee it“. Furthermore ”world-class SOPs and controls aren’t enough“. ”Quality is everyone’s responsibility“ – this  quote of William Deming from the nineteen sixties is not really a new statement. However, it seems that this principle is not being followed in the majority of companies in the pharmaceutical industry. Carmelo Rosa, FDA, summarized in a presentation “Quality is more than GMP!”

Investigations are a source of deficiencies

The presentation of the top 10 deficiencies of GMP inspections performed by the FDA is always well attended. This year the top citations in Establishment Inspection Reports (EIR) are (period from October 1, 2011 until September 11, 2013):

#1: 21 CFR 211.22(d) (307 citations)
Responsibilities of quality control unit

#2: 21 CFR 211.192 (234 citations)
Production record review

#3: 21 CFR 211.100(a) (214 citations)
Written procedures; deviations

#4: 21 CFR 211.160(b) (198 citations)
General requirements

#5: 21 CFR 211.110(a) (149 citations)
Sampling and testing of in-process materials and drug products

#6: 21 CFR 211.67(b) (139 citations)
Equipment cleaning and maintenance

#7: 21 CFR 211.67(a) (131 citations)
Equipment cleaning and maintenance

#8: 21 CFR 211.165(a) (123 citations)
Testing and release for distribution

#9: 21 CFR 211.68(a) (121 citations)
Automatic, mechanical, and electronic equipment

#10: 21 CFR 211.100(b) (119 citations)
Written procedures; deviations

This year’s shooting star was the GMP deficiency in investigations (21 CFR 211.192) as #2 this year with 234 citations. Consequently that workshop on investigation following the conference was visited by more than 200 participants.

If you summarize #3 and #10 (both are 21 CFR 211.100) the observations with “Written procedures; deviations” would be #1. It seems that deviation systems and productions record documentation are the key issues at the moment.

Data Integrity is in the Focus

Carmelo Rosa from the FDA presented the most important deficiencies, observations and international collaboration issues. He also pointed out, that a key issue in inspections was data integrity. If you are preparing for an FDA inspection have a look at that topic in your organisation. It is important as many conclusions are made with data gathered from electronic systems. Trust in your data is of upmost importance. Without confidence in your data integrity you cannot rely on them. As summary of numerous observations they expressed that it is not a problem for industry to have appropriate SOPs but to follow them. Carmelo Rosa also stressed the obvious challenge for the industry to move from a reactive quality system to a proactive quality framework.

New Office for Pharmaceutical Quality

Early in the morning the FDA also talked in a breakfast session about their reorganisation effort. The FDA will found a new office within the organization. The “Office for Pharmaceutical Quality (OPQ)” will start in 2014. Drivers are the need for one program for drug quality across generic, brand, and OTC drugs. The FDA has the same quality expectations for all marketed drugs (=clinical performance). Also the FDA aims to promote expertise-based standards and wants to shift towards risk-based actions and to move on to a modern organizational structure and function.

The 3-day conference was filled with very interesting presentations and Maas & Peither will report from single sessions in the next LOGFILES.

Topics that have been discussed in the conference sessions were:

  • Quality culture & partners
  • Quality agreements
  • New facility design options
  • FDA’s expectations for a submission
  • GMP for API’s, excipients and components
  • Development and technical transfer
  • Understanding metrics
  • Microbiology and chemistry lab findings
  • Distant process monitoring
  • Understanding good manufacturing practices
  • Good distribution practices
  • Outsourcing innovation
  • Managing supply crisis/drug shortages
  • International inspections and collaboration
  • Combination products and companion diagnostics
  • Lifecycle towards commercial manufacturing
  • Post inspectional follow-up
  • Submission review
  • Continuous improvement
  • CDER reorganization
  • Compliance update & center initiatives

There is a lot we could talk about.

But keep in mind: 
“Quality is more than GMP compliance.“


Thomas Peither
Maas & Peither AG - GMP Publishing;
Maas & Peither America, Inc.;
Peither & Consultants GmbH

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