Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials

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1 Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials Ron Hinkel, Director Quality Systems BioReliance Inc. Patti Rossman, President Globiox

2 Purpose Keep pace with current regulatory interpretation. Help manage / position testing performed during the drug development life cycle regarding regulatory interpretation.

3 Scope Guideline for Regulations used to: Standardize internal operations Provide a guide for clients Provide a tool for inspections

4 Development Recent FDA/ EMA guidance documents BREL / Globiox Quality, Regulatory Affairs, Operations, and Commercial Operations Experience Industry Quality / Regulatory Affairs thought leaders

5 Basic Concepts Defines the recommended regulatory level of testing (GLP / GCP / GMP / CLIA) for a product appropriate to the intended use of the data generated. Maintain flexibility between development and clinical trial materials. Fulfill FDA/EMA expectations concerning drug testing position to regulations.

6 Some References 21 CFR Part , Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals. 21 CFR Part 58, Good Laboratory Practice for Non-Clinical Laboratories Studies. ICH Q9, Quality Risk Management. EU Guide to GMP. European Clinical Trials Directive 2001/20/EC. UK MRHA GLP Regulations. ICH E6, Good Clinical Practice. Clinical Laboratory Improvement Amendments (Title 42-Public Health, Part 493, Laboratory Requirements).

7 Basic Principles of GLP for Labs 1. In order to have GLP, you must have a Test Article and a Test System. 2. GLP is NOT relevant to all regulated laboratory tests. 3. GLP is only relevant to non-clinical testing. 4. A GLP study can only have ONE Study Director.

8 Basic Principles of GMP for Labs 1. GMP applies to some laboratory testing. 2. If a laboratory test is done to support manufacturing of a drug product it should be in compliance with GMP.

9 Basic Principles of GCP for Labs 1. FDA GCPs do not specifically address lab testing 2. ICH E6 (GCP) defines lab data as source data for clinical trials 3. FDA does have Guidelines and regulations concerning Electronic data. 4. US uses CLIA certification.

10 GLP, GMP, or GCP?? So, how do we as laboratorians know which Regulation to follow?

11 Definitions GLP = Current Good Laboratory Practices GCP = Current Good Clinical Practices GMP = Current Good Manufacturing Practices CLIA = Clinical Laboratory Improvement Amendments NRT = Non-Regulated Testing EU = European Union

12 Biosafety Testing Sample Type Drug Product / Cell Banks Raw Materials Drug Product / Cell Banks Drug Product / Cell Banks Drug Product / Cell Banks Drug Product in Animals Cell Banks Drug Product Intermediate Characterization Data Use Release / Characterization / Stability Release Stability In Vivo Safety (Release) In Vivo Safety (Non Release) In Vitro Testing (Viral Detection) Clearance Studies Applicable Regulatory Standard

13 Biosafety Testing Sample Type Data Use Drug Product / Cell Banks Characterization NRT / GMP Raw Materials Release / Characterization / Stability NRT / GMP Drug Product / Cell Banks Release NRT / GMP Drug Product / Cell Banks Stability NRT / GMP Drug Product / Cell Banks In Vivo Safety (Release) NRT / GMP Applicable Regulatory Standard Drug Product in Animals In Vivo Safety (Non Release) GLP Cell Banks In Vitro Testing (Viral Detection) NRT / GMP Drug Product Intermediate Clearance Studies GLP* *Historically GLP, Under Debate, EU moving to GMP

14 Toxicology Sample Type Data Use Applicable Regulatory Standard Drug Product / Medical Device / Cosmetics / Chemical Intermediates In Vivo Safety Drug Product In Vivo Efficacy Drug Product in Media / Cells In Vitro Safety

15 Toxicology Sample Type Data Use Applicable Regulatory Standard Drug Product / Medical Device / Cosmetics / Chemical Intermediates In Vivo Safety GLP / NRT Drug Product In Vivo Efficacy GLP / NRT Drug Product in Media / Cells In Vitro Safety GLP / NRT

16 Clinical Genomics Sample Type Data Use Applicable Regulatory Standard Drug Product / Medical Devices / Combinations in Humans In Vivo Safety Human Specimens Drug in Human Matrix Human Specimens Drug in Human Matrix Human Specimens Human Specimens Efficacy Pharmacokinetics Pharmacogenomics Pharmacovigilance ADME Panel Immunogenicity

17 Clinical Genomics Sample Type Data Use Applicable Regulatory Standard Drug Product / Medical Devices / Combinations in Humans In Vivo Safety GCP / CLIA Human Specimens Efficacy GCP / CLIA Drug in Human Matrix Pharmacokinetics GCP - EU GLP - US Human Specimens Pharmacogenomics GCP / CLIA Drug in Human Matrix Pharmacovigilance GCP / CLIA Human Specimens ADME Panel NRT / CLIA / GCP-EU Human Specimens Immunogenicity GCP / CLIA

18 Observations Regulatory testing level should be linked to Drug Development Life Cycle Phase Industry is currently testing to GLP in situations that should be GMP GCP is not a formal regulation controlling product testing, but laboratory testing records are source data and must be controlled as source data

19 More Observations Tables acknowledge differences in FDA/EU regulatory interpretations Clearance Studies Pharmacokinetics ADME Panel Cell Banks are being considered as GMP raw materials

20 Contacts Ron Hinkel, Director of Quality, BioReliance Patti Rossman, President, Globiox