Validation and Qualification Overview

1. Validation and Qualification Overview Mike Garry Software Product Manager Spectroscopy Software Platform Team

2. Customer Regulatory Requirements • Control in the generation and archiving of analytical data • Rigorous documentation • Is the system “Fit for purpose”? • Controlled by predicate regulations that apply: • cGMP, GLP for Pharma • ISO 9000 for non-Pharma • In the pharmaceutical industry this requires complete system validation

3. GLP Good Laboratory Practices 21 CFR Part 58 Required for non-clinical studies supporting NDA submissions Often used as general guidelines for laboratory quality management cGMP current Good Manufacturing Practices 21 CFR Part 210 & 211 Required for all aspects of manufacturing, processing, and packaging of a drug Used for quality control in drug manufacturing GLP vs. cGMP

4. What is Validation, Anyway?

5. Validation of a Spectrometer • Process of ensuring that the complete system (more than just the spectrometer) is fit for a specific process or application • Instrument • Software • Method • SOPs • cGMP and GLP requirement • Typically performed by instrument owner, however; • Thermo Fisher Scientific provides the customer with tools that are needed to complete validation • Thermo Fisher Scientific can also provide custom spectrometer validation services to do complete end-to-end validation through our Spectroscopy Validation Program

6. The FDA’s View Confirmation by examination and provision of objective evidence that... specifications conform to user needs and intended uses, and that the particular requirements implemented… can be consistently fulfilled. - FDA Guidance Document (1999)

7. User User User User Requirements Requirements Acceptance Acceptance Specifications Specifications Testing Testing Functional Functional System System Specifications Specifications Testing Testing Integration Design Testing Specifications Build Build System System The Big “V” View of Validation This is the process we use to design and develop products.

8. Qualification vs. Validation • Qualification is a stage in the validation process • Qualify individual areas of a process • For example FT-IR instrument used for drug development • The exact requirements for qualification and validation will vary depending on the environment used • R&D vs. clinical laboratory vs. production facility • Four parts of qualification (The 4 Q’s) • Design Qualification (DQ) • Installation Qualification (IQ) • Operational Qualification (OQ) • Performance Qualification (PQ)

9. Instrument Life Cycle Management – How Thermo Fisher Scientific Helps

10. PQ OQ IQ DQ Qualification Steps - Example Customer is ultimately responsible, they look to vendors to provide the tools!

11. Design Qualification (DQ):Customer’s Responsibility • Done before system purchase • User defines critical features and specifications of the system • They must ensure the instrument specifications meet the analytical method requirements • Must compare environmental needs of instrument to conditions of proposed location • They typically analyze the vendor’s product development process • Questionnaires • Audits

12. Design Qualification (DQ):Vendor’s Responsibility • Document hardware/software development process • Product Development Process (PDP) • ISO 9001 certification • Quality system • Hardware and software validation • Product design, manufacturing, testing, and support • Traceability • Design process • Development process • Data and bug tracking • Change control notice • Problem escalation

13. Installation Qualification (IQ) • Verification and documentation that the instrument is: • received as ordered and specified in DQ • defect and damage free • installed properly in the correct environment • meets manufacturer’s specifications • Includes all aspects of the instrument set-up: • hardware, software, documentation, log book present • power up, software control, data output • Performed by customer or vendor • trained and certified service technician (proof required) • ValPro Installation Certification services provide factory traceability • may include checklists or testing scripts

14. Operational Qualification (OQ) • Verifies that the hardware & software operate according to specifications • system performance tests • done as part of IQ • tests that the - • spectrometer runs as a spectrometer • software runs as expected • accessories operate properly • operators trained in basic instrument use • Thermo Fisher Scientific provides tools and services to complete OQ of spectrometer (Installation Certification) • Repeated after major service, moves or annually as determined by the instrument owner

15. Operational Qualification (OQ) • Verifying that the software/hardware operates according to specifications • routine performance tests • frequency defined by system owner • generally includes a subset of the IQ test • tests that the spectrometer runs as a spectrometer • Responsibility of customer • define SOPs • define tests to run and frequency • Thermo Fisher Scientific provides tools and services to complete OQ of spectrometer (Installation Certification) • For software this is a detailed functionality test • plan for verifying that the software operates according to specifications

16. PerformanceQualification (PQ) • Tests and documents system to be adequate for specific task as it relates to the manufacturing process • unique to every location and use • includes spectroscopic method verification (system suitability) • documents system is fit-for-purpose • SOPs (Standard Operating Procedures) must established and followed • Includes ongoing performance verification tests and re-qualification • Intervals determined by the system owner • Tailored to: • user • experiment • SOP for instrument use

17. Qualification & Validation Tools • ValPro System Qualification for laboratory FT-IR & Raman • ValPro System Qualification for Antaris FT-NIR and IGS • Include: • DQ documentation • IQ and OQ procedures • Qualification tests • Traceable standards • Services available include: • Installation certification • System operation certification • Provided by certified engineers • Validation services available through the Spectroscopy Validation Services Group

18. Software Qualification Products • OMNIC DS Software OQ • Detailed tests of 21 CFR Part 11 features of OMNIC and Thermo Security Administration software. • Comes in bound manual and PDF format • Included with OMNIC DS package • OMNIC Test Scripts for Software OQ • Detailed tests for most common OMNIC commands and operations • Tests general OMNIC operation • Same test scripts that are performed when OMNIC is released • Document format for manual execution and signoff • Documents provided in PDF and DOC format • Additional charge for this package