GXP Inspection readiness. Beyond Compliance

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1 GXP INSPECTION READINESS BEYOND COMPLIANCE Publication date: May 18, 2017 Author: Arete-Zoe, LLC ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/

2 Experienced and successful developer of full spectrum multi- service and inter-agency operational plans and policy with proven ability to implement and improve programs through broad-based competencies in: All Source Intelligence Collection Planning, Management, Analysis Analysis determining vulnerabilities of industrial infrastructures and social institutions Decision Making Process/Analytical Problem Solving Deliberate and Crisis Action Planning Training and Exercise Development/Systems Approach to Training (SAT) and Simulations Specialties: Mapping and assessment of complex organizational relationships and operational interdependencies to determine potential vulnerabilities in policy, plans, procedures, training, staffing, and job task distribution that directly support organizational effectiveness for competitive agility, business resiliency, and preparedness for continuity of operations. Well-versed professional with degree in clinical veterinary medicine, pursued a dual career in biomedical research and drug safety, with broad experience within the pharmaceutical and medical devices industry. Main competencies include: Global Markets regulatory/legislative frame work affecting pharmaceutical and health services Design and implementation of industry-relevant information collection and analysis Analysis and optimization of pharmaceutical industry and healthcare sector specific processes Drug discovery, development and commercialization process Systems approach (SAT) to solution development in the pharmaceutical and healthcare sectors Specialties: design and implementation of pharmacovigilance, pharmaceutical information and medication management systems, including innovative approaches to data collection, analysis and sharing; assessment and optimization of pharmaceutical supply chain, and design and implementation of training solutions in the pharmaceutical and healthcare sector. Ronald Sheckler Veronika Valdova

3 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ ICH Guidelines 21 CFR part 210 FDA Guidelines WHO Guidelines EU legal framework National: EU, IN, CN ICH Guidelines 21 CFR part 58 FDA Guidelines WHO Handbook EU legal framework OECD National: EU, IN, CN USP 1079 and 1083 DSCSA FDA Guidelines WHO Guidelines EU legal framework National: EU, IN, CN ICH Guidelines 21 CFR WHO Guidelines EU legal framework National: EU, IN, CN ICH Guidelines Post-Market Surveillance WHO Guidelines EU legal framework National: EU, IN, CN INTEGRATED APPROACH

4 Author: Ronald L Sheckler

5 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP Fig 2. Estimated US preclinical research spend and categories of errors that contribute to irreproducibility. Freedman LP, Cockburn IM, Simcoe TS (2015) The Economics of Reproducibility in Preclinical Research. PLOS Biology 13(6): e1002165. https://doi.org/10.1371/journal.pbio.1002165 http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1002165 Unchallenged assumptions lead to study failures

6 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP Main manufacturing sites: USA Europe Switzerland Germany UK Ireland Belgium Spain Austria Poland Slovenia Raw materials import API manufacturing issues Limited sourcing options Shipping routes Geopolitical changes Civil disruption

7 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP Reasons for shortages:

8 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP All studies Open studies All studies Open studies

9 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP All studies Open studies All studies Open studies …without integrity, study data can be worthless

10 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP Strait of Malacca Bab el Mandeb Suez Gibraltar Strait of Hormuz Panama South China Sea IMB Piracy & Armed Robbery Map 2017 Shipping times Accidents Piracy / Territory disputes Product custody chain Cargo damage/loss Counterfeit products

11 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP Strait of Malacca Bab el Mandeb Suez Gibraltar Strait of Hormuz Panama South China Sea IMB Piracy & Armed Robbery Map 2017 Shipping times Accidents Piracy / Territory disputes Product custody chain Cargo damage/loss Counterfeit products Hotspots: South China Sea, Strait of Malacca, Horn of Africa, Eastern Mediterranean

12 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP “Hundreds of tons of dangerous chemicals had been illegally stored at the warehouse, helping to create a toxic cocktail that burnt through buildings with ease, leaving deformed shipping containers and melting hundreds of cars as it went.” (SCMP, 2016)SCMP, 2016 Tianjin, 2015

13 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP

14 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ GLP GMP GCP GDP GVP Major risks revealed only due to post-market surveillance, inflicting significant loss

15 INSPECTIONS FDA and MHRA GXP inspection metrics ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/

16 Total: 324 | UK: 242 | Overseas: 82 (MHRA, 2017)

17 ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/ Innovative: 25 | Generics: 20 | Other: 2 (MHRA, 2017)

18 ORA Inspection Observations FDA: Inspection Observations, 2017 Number of 483 issued from the System* Inspections ending between 10/1/2015 and 9/30/2016 Center Name483s Issued Biologics84 Bioresearch monitoring215 Devices934 Drugs691 Foods2196 Human tissue for transplantation92 Parts 1240 and 125097 Radiological health32 Veterinary medicine281 Sum Product Area 483s from System*4622 Actual Total in System 483s**4528

19 (FDA, 2017) Bioresearch monitoring (BIMO)

20 OSI & OSIS Application- Inspections FDA: BIMO Metrics, 2017

21 OSI & OSIS Warning Letters FDA: BIMO Metrics, 2017

22 ARETE-ZOE, as a consultancy, provides solutions to complex problems in the high stakes and high consequence environment of Global Pharmaceuticals, including clinical research, healthcare informatics, and public health. We blend established, Pharma sector methodologies, innovation, and adaptations/transfers from other sectors to identify and resolve consequential practices that pose risk and often result in avoidable patient casualty. However, we are specifically, not a patient advocacy group but believe in optimizing organizational effectiveness and that smart business is agile, competitive and profitable, while intrinsically safe, secure, and resilient. We work within a global context because transnational interests influence national circumstances and choices at point of prescription. ARETE-ZOE, provides full spectrum organizational and operational risk management consultancy. Our published materials provide a glimpse of some aspects of our services to demonstrate both knowledge and ongoing participation within the Pharmaceutical Industry. Our analysis and consultancy includes all channels of misuse, diversion, counterfeiting and illicit exploitation of pharmaceuticals, medical devices, and precursor chemicals. Our advisement is to manufactures, jurisdictional entities, insurers, legislators, litigators, patients, and health care providers. ​ This scope also frequently segues into the nexus of crime and terrorism as significant influencers that undermine sector integrity differentiated from other criminal activity. Obviously, vulnerability assessment, information collection management and intelligence production supporting decision-making for risk reduction and interventions are routinely within the scope of our services as well as design and implementation of operational control measures. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/