1. Trends in GMP Compliance: 2012
With a focus on pharmaceuticals rather than medical
devices to serve as a useful reference and management
guide for the Small and Medium Business (SMB)
pharmaceutical sector in emerging markets.

2. Acknowledgement
• This presentation is an adaptation by Mitchell Manning ,
chapter author, of Chapter 24 – Trends in GMP Compliance in
the book “Achieving Quality and Compliance Excellence in
Pharmaceuticals” published by Business Horizons.
Mitchell W. Manning, Sr.
manningmitch@aol.com
252-714-3481 cell
Amazon.Com

3. What Are Trends In GMP Compliance?
For the purpose of this presentation, a trend is defined as
direction or movement over 3 or more years with high
probability for increasing. The trends with the greatest
potential impact in the pharmaceutical sector since 2006 in
priority order are:
1. Increasing Number of Inspections
2. Increasing Number of Warning Letters
3. Increasing Enforcement Penalties
4. Increasing Harmonization between Regulatory Agencies
5. Increasing Use of Science and Technology
6. Increasing Use of Subject Matter Experts

4. How do you feel about these trends
and the impact on your work and your
organization?
What will you do differently in your
work as a result of knowing this trend?
Knowledge of GMP trends can be used for developing, leading, managing,
and building a GMP compliant work ethic and organizational culture.

5. Why identify GMP Compliance Trends?
Knowledge of GMP Compliance Trends can be useful in the pharmaceutical sector to
guide daily work, lead and manage operational control, and to develop and
execute strategic planning.
GMP trends are applicable to:
 Construction and commissioning of a major pharmaceutical manufacturing site
 Start-up and operation of an active pharmaceutical ingredient complex
 Validation of a state-of-the-art steriles manufacturing complex
 Training and development of employees and project teams from all levels and
disciplines in pharmaceutical research, development, manufacturing , marketing,
and sales

6. Your Perspective Matters Most
1. What is your opinion on 3 to 5 leading trends in
GMP compliance for pharmaceuticals?
2. What is the value to you in knowing the regulatory
compliance trends?
3. How can a small to medium size company best use
knowledge of the current trends?

7. Global Perspectives
• “to learn and become better prepared for future inspections”
Information Technology Specialist
Mid-size Pharmaceutical Company
• “to hopefully prevent serious problems later on that would put us, or our
customers, at risk including the regulatory agencies that regulate us!"
Division Vice President, Compliance Oversight
Large Global Pharmaceutical Company
• "what are we doing to prevent this citation from being ours? “
President and Chief Operating Officer
Medium size Global Compliance Consulting Company
• “put companies on alert to strengthen their SOPs—the way they are written and
the way they are used to train personnel."
Principal, Global GMP Training Company

8. How to Identify and Use GMP
Compliance Trends
• Go to the websites of pharmaceutical regulators, pharmaceutical
periodicals and publishers, pharmaceutical associations and
conferences, pharmaceutical consultants, pharmaceutical vendors,
pharmaceutical contractors, and corporate pharmaceutical
companies.
• Used knowledge of the GMP Compliance Trends to aid in: strategic
planning and operational control, financial planning, employee
recruitment and development, development of policies and
procedures, development of performance management systems
and documents, and development, execution, and evaluation of
internal and external audits.

9. Trend One/Priority One:
Increasing Number of Inspections
• The driver of the GMP Compliance 2012 trends.
– Be prepared for the GMP inspection.
– Know your primary regulatory agency and GMP inspection process
– Be prepared by ensuring GMP compliance though-out your quality system.
– Communicate successful inspections are a requirement.
• Why the increase in the number of inspections?
– the industry history (globally) of non-compliance to GMPs
– In the United States there are nearly two hundred more inspectors than
just 5 years ago.
– The U.S. Congress has responded to citizen pressure for stronger
regulations of the industry by supporting expansion of regulatory
oversight and the federal funding requirements for increased inspections.

10. How to Insure a Successful Inspection
• Build an Integrated Quality System
• Embrace the GMP Quality Systems Approach
• Prove the GMP Capability and Control Cycle
• Apply GMP Process Analytical Technology

11. Trend Two/Priority Two:
Increasing Number of Warning Letters
"When FDA finds that a manufacturer has significantly violated
FDA regulations, FDA notifies the manufacturer. This
notification is often in the form of a Warning Letter. The
Warning Letter identifies the violation, such as poor
manufacturing practices, problems with claims for what a
product can do, or incorrect directions for use. The letter also
makes clear that the company must correct the problem and
provides directions and a timeframe for the company to
inform FDA of its plans for correction. FDA then checks to
ensure that the company’s corrections are adequate.”
http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf

12. Trend Three/Priority Three:
Increasing Enforcement Penalties
• Administrative actions include product recalls, debarment of
individuals or companies who have been convicted of
felonies, withdrawals of product approvals, license
revocations, and disqualification of clinical investigators.
• Judicial actions include seizures of violative products,
injunctions, criminal prosecutions, and certain civil money
penalties.
http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm254426.htm

13. Trend Four/Priority Four:
Increasing Harmonization between
Regulatory Agencies
• The International Conference on Harmonisation (ICH), the Pharmaceutical
Inspection Convention and the Pharmaceutical Inspection Co-operation
Scheme (PIC/S), and the World Health Organization are global
organizations promoting global harmonization between GMP regulatory
agencies.
• FDA Commissioner Margaret Hamburg supports and speaks about
harmonization of global regulatory agencies. Follow this link to view her
comments on harmonization and world health on YouTube:
http://www.youtube.com/watch?v=BZ9GL9oNBXI&feature=related

14. Trend Five/Priority Five:
Increasing use of Science and Technology
• The use of the internet by the pharmaceutical sector and the GMP
regulators is a visible, vocal, and ever present reminder of
advancing science and technology. Vendors to the pharmaceutical
sector, consultants, customers, and employees using social media
hardware and software to share information, knowledge, and
opinions are a dramatic demonstration of the increasing use of
science and technology.
• Follow this link to hear FDA Commissioner Margaret Hamburg
speak on the FDA's increasing use of science and technology.
http://www.youtube.com/watch?v=JAh-kc0yxTY&feature=related

15. Trend Six/Priority Six:
Increasing use of Subject Matter Experts
• The increasing number of former regulators now serving as consultants to the pharmaceutical
industry is increasing. The drain on intellectual capital at the FDA has been increasing for many
years. Many inspectors exit FDA just after completing the inspector learning curve to become
industry consultants. This creates as great a problem for the pharmaceutical sector as it does for
the FDA. The FDA loses intellectual capital and the industry is inspected by an inspection team on a
dual mission. New inspectors are highly motivated by missionary zeal to protect the public health
and to establish GMP inspector credentials. New inspectors are intelligent, well educated in
required disciplines, expertly trained on the inspection process both technically and behaviorally,
and focused on protecting the consumer by conducting and documenting detailed quality systems
inspections.
• The regulators and the pharmaceutical sector have an increasing need for subject matter experts as
science and technology advance. “We have to be sure that FDA has subject-matter experts that we
need for our important decision making,”11 Margaret Hamburg, Commissioner of the FDA tells us.
Follow these links to learn more about the FDA's use of Subject Matter Experts in Scientific Priority
Areas:
http://www.genengnews.com/keywordsandtools/print/3/26290/

16. Conclusion:
Trends in GMP Compliance 2012
• The Trends In GMP Compliance 2012 indicate there is
a problem with GMP thinking in the global
pharmaceutical sector. The regulators know this,
government representatives know this, and,
customers/consumers know this. It is going to
become more difficult and more expensive to be in
this business. Unless, the Trends In GMP Compliance
are used as a "call to action" to become GMP
compliant in all disciplines and all levels for the
purpose of promoting and protecting the public
health.

17. References
• 1 http://asq.org/fdc/2006/02/cgmp-compliance-trends-an-industry-persepctive.ppt
•
• 2 http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM256376.pdf
•
• 3 http://goarticles.com/article/How-Growing-Companies-Can-Adequately-Prepare-for-an-FDA-Inspection/6127821/.
•
• 4 http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm259848.htm
•
• 5 http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194986.htm
•
• 6 http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm254426.htm
•
• 7 http://www.ich.org/
•
• 8 http://www.picscheme.org/
•
• 9 http://www.who.int/about/en/
•
• 10 http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm274447.htm
•
• 11 http://www.genengnews.com/keywordsandtools/print/3/26290/
• Other Recommended Sources:
•
• http://www.globepharm.org/what-is-gmp/international-GMPs/gmps.html
•
• http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf
•
• http://www.youtube.com/watch?v=BZ9GL9oNBXI&feature=related
•
• http://www.youtube.com/watch?v=JAh-kc0yxTY&feature=related