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.
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. firstname.lastname@example.org 252-714-3481 cell Amazon.Com
What Are Trends In GMP Compliance?For the purpose of this presentation, a trend is defined asdirection or movement over 3 or more years with highprobability for increasing. The trends with the greatestpotential impact in the pharmaceutical sector since 2006 inpriority order are:1. Increasing Number of Inspections2. Increasing Number of Warning Letters3. Increasing Enforcement Penalties4. Increasing Harmonization between Regulatory Agencies5. Increasing Use of Science and Technology6. Increasing Use of Subject Matter Experts
How do you feel about these trendsand the impact on your work and yourorganization?What will you do differently in yourwork 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.
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
Your Perspective Matters Most1. 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?
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
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.
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.
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
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
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
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
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 FDAs increasing use of science and technology. http://www.youtube.com/watch?v=JAh-kc0yxTY&feature=related
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 FDAs use of Subject Matter Experts in Scientific Priority Areas: http://www.genengnews.com/keywordsandtools/print/3/26290/
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.