Validation Strategies for Equipment from Multiple Vendors

Transcription

1 Welcome to our E-Seminar: Validation Strategies for Equipment from Multiple Vendors Page 1

2 Content FDA guidelines and inspectional observations Validation & Qualification Approaches Instrument Qualification in Multi-Vendor Environments Page 2

3 Warning Letters - Laboratory Related There were no written procedures for the HPLC system on validation, on HW & SW change control, revalidation, user operations, data and system security, disaster recovery, back-up and audit trail archive. The functional, operational and security features of the data acquisition and storage HPLC software have not been challenged or validated for accuracy or for reliability. The HPLC system was not validated to show that info was accurately exchanged between the hardware (HW) and the software (SW). Ref: Page 3

4 Validation Definition.. establishing documented evidence which.. establishing documented evidence which provides a high degree of assurance that a provides a high degree of assurance that specific process will consistently produce a specific process will consistently produce a product meeting its predetermined product meeting its predetermined specification. specification. Source: FDA guidelines on General Principles of Validation, Source: FDA March guidelines 1986 on General Principles of Validation, March 1986 Continuous process Specify/ develop Change control Check for specification and document results Validation means nothing else than well-organized, well- documented Validation means nothing else than well-organized, well- documented common sense (Ken Chapman, 1985) common sense (Ken Chapman, 1985) Page 4

5 Validation Master Plan Scope, e.g., for all regulated environments Glossary, e.g., validation Responsibilities, e.g., validation team Steps for validation, e.g., V or 4Q model Procedures for tests and acceptance criteria Release procedure, e.g., who has to approve Content of validation report Documentation and archiving Discontinuance URS FS DS Build DQ IQ OQ PQ OQ IQ PQ Example masterplan for equipment - computers - networks Page 5

6 Common Qualification Terms Guideline: Although vendors may provide information and documentation to assist their users in meeting their responsibilities under the IQ and OQ, validation remains the responsibility of the end user. I. Design Qualification (DQ) Defines the functional and operational specs of the instrument and details the conscious decision in the selection of the supplier II. Installation Qualification (IQ) "Establishes that the system is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation of the system." III. Operational Qualification (OQ/PV) "The process of demonstrating that an instrument will function according to its operational specifications in the selected environment." IV. Performance Qualification (PQ) "The process of demonstrating that an instrument consistently performs according to a specification appropriate for its routine use. Page 6

7 The Homogeneous Laboratory Environment Limited types of equipment Supplied by a single vendor One harmonized plan One qualification procedure One service provider Page 7

8 The Typical Laboratory Environment Mixed Vendor LC/MS Chillers/Heaters Chromatography equipment from multiple vendors Dissolution Refrigerators/Freezers ph meters Page 8

9 Instrument Qualification in the Typical Lab Environment Multiple qualification procedures for similar types of equipment Multiple testing conditions Multiple reports types Multiple service providers Increased time and effort Increased difficulty justifying procedures for regulatory audit Increased cost Page 9

10 Agilent s Harmonized Compliance Service A single, consistent approach to instrument hardware qualification that is vendor-neutral in scope. Agilent offers a full complement of preventative maintenance (PM), installation qualification (IQ), and operational qualification (OQ) services Broad availability backed by Agilent Technologies Reduction of costs associated with audit preparation or challenged audits Focus on your mission, not on compliance Agilent Technologies and LabMetrix Technologies have teamed to offer the most comprehensive instrument compliance services available. Page 10

11 Multi-Vendor Qualification Services Multi-Vendor, Multi-instrument Equipment List Page 11

12 A Consistent Metrology-Based Approach The key to harmonized qualification is use of the GLP-100 GLP-100 System is an integrated NIST- and COFRAC-traceable validation tool for any brand LC, LC/MS/MS, GC, GC/MS, CE, Oven A tool that measures the basic physical parameters of instruments Allows for standardization AND flexibility - definable test conditions Designed to qualify a broad range of instruments, independent of instrument manufacturer Allows a straightforward comparison of the performance of instruments from multiple manufacturers Helps make instrument validation a traceable, repeatable and efficient process while maintaining compliance with FDA and ISO regulations Page 12

13 Rigorous Quality Processes Software validated according to GAMP 4 guidelines establishes a common language and terminology improves compliance with regulatory expectations by defining a common and comprehensive life cycle model clarifies the division of responsibility between user and supplier provides better visibility to agreed quality standards aids the production of systems that are fit for purpose and that meet user and business requirements Audit-ready documentation Formal change-control process for documents, software and delivery-equipment Qualified (IQ and OQ) control & acquisition software (GLP 100) Systems calibrated and traceable to international standards Formal certification process for delivery engineers Page 13

14 Break Number 1 Please type your question into the Chat Box at any time during the presentation. Page 14

15 Example A Validation of a HPLC System Pump Automatic Injection Diode Array Detector Column Heater Digital Data Acquisition Page 15

16 Pump System User selects 3 flow rates Test parameters Accuracy (Module pass/fail recommended) Stability (Module pass/fail recommended) Linearity over selected range Flow vs. Pressure stability Gradient Linearity (Module pass/fail recommended) Page 16

17 Automatic Injector and Column Compartment User selects 5 injection volumes Test parameters Reproducibility (Module pass/fail recommended) Relative accuracy Linearity User selects 3 temperature settings Test parameters: Temperature accuracy (Module pass/fail recommended) Temperature stability (Module pass/fail recommended) Temperature linearity Page 17

18 DAD/PDA Detector User selects 10 wavelength settings Test parameters: Wavelength accuracy (Module pass/fail recommended) Wavelength linearity Response linearity (Module pass/fail recommended) Noise (Module pass/fail recommended) Drift Zero offset 40 Target Wavelength R espon se Impurity Spectra Drug Spectra Wavelength (nm) Page 18

19 Multi-Vendor OQ Report Qualification Date 7-Aug-02 QUALIFICATION REPORT HPLC N 02QQ0708-R1P1 Company XYZ PharmaCo 9780 South Meridian Blvd Tested Module System ID: HPLC US01 Module ID: P01 Englewood Colorado Type: HPLC PUMP Test Location: Support Lab Manufacturer/Model Number: AGILENT G1311A Department: Training Center Serial Number: DE Location: Room 214-A Entered Service: 30-Sep-99 Operator: Jane Jones Last Qualification: 28-Sep-01 Title: Compliance Engineer Next Qualification: 7-Aug-03 Operating Conditions Details of GLP100 Pump: A GLP100 Serial Number : RY413 Duration (min): 60 Date Calibration Expires : 31-Jan-03 Solvent: Deionized Water Maximum Pressure (Bar): Protocol N : PR Flow (ml/min): Equipment Used (ID, Type, Model, Serial N, Report N ) Standard Solution Reference: Potassium Dichromate 981 GLP100 Detector Batch Number: 0270KDC-EPC50X-1 Date Solution Expires: 9-Sep-02 ab Temp and Humidity ( C_%RH): _ STATISTICAL SUMMARY Qualification Date 7-Aug-02 FLOW RATE STABILITY - FLOW 1 Table of measured Flow 1 - Stability results ml/min Time (min) Series 1 Pressure (Bar) Series 2 Pressure (Bar) Mean RSD (% ) 0.16% 0.00% 0.05% 0.65% Max. Difference ml/min Bar ml/min Bar Mean (20 Values) (ml/min) Mean RSD (Flow) (% ) % P01 HPLC PUMP AGILENT G1311A DE QQ0708-R1P1 PARAMETERS Pump Measured Specification Min Max COMPLIES Flow YES NO GRAPHS OF FLOW RATE STABILITY - FLOW Flow Rate Stability % 1.00% X (% ) % 1.00% X % 1.00% X Accuracy % X (ml/min) % X % X Flow/Pressure Stability (% ) 0.24% 2.00% X Flow Linearity (% ) 1.27% 8.00% X A-B 0.22% 2.00% X Gradient Linearity (% ) C-B 0.17% 2.00% X D-B 0.23% 2.00% X Débit Flow (ml/min) (ml/min) Pressure (Bar) Pression (Bar) MODULE COMPLIES YES MODULE COMPLIES YES NO NO SIGNATURES XYZ PharmaCo SIGNATURES For Agilent Technologies Approval Date:7 -Aug-02 John Smith - Quality Manager Report Date: 7-Aug-02 Jane Jones This document is the property of Agilent Technologies under license from LabMetrix Technologies. No copying, all or partial, is permitted without prior authorization Temps (min) Time (min) Series 1 Series 2 Pressure (Bar) Pressure (Bar) Series 1 Series 2 Pressure (Bar) Pressure (Bar) For Agilent Technologies: Report Date: 7-Aug-02 This document is the property of Agilent Technologies under license from LabMetrix Technologies. No copying, all or partial, is permitted without prior authorization Page 19

20 Qualification Process & Documentation Flow (1) Detailed equipment list created Qualification Master Plan (QMP) developed QMP details testing specifications for all equipment to be qualified Special operating conditions (SOC) developed & documented, as needed Internal QMP quality review and customer review eqmp downloaded to GLP 100 software (acquisition & control) for GLP 100 system control (self-contained, calibrated, metrology device) Delivery schedule defined and implemented Page 20

21 Qualification Process & Documentation Flow (2) OQ pass review with customer interim qualification report & calibration certificate left for each module final qualification report and calibration packet within 10 days OQ failure calibration certificates (for instruments) certificates of analysis (chemical standards) engineer s training record SOC report (if required) review with customer qualification form indicates failure detail after repair, RQ implemented from GLP 100 software RQ report added to initial OQ report (note: failure is electronically documented & cannot be deleted) eqmp and SOCs are retained for the lifetime of qualification service specific instrument details and qualification history electronically archived for 5 years Page 21

22 Qualification Protocols Protocol Contents: Scope Definitions Applicable documents Range of application Operational Qualification Formulae Qualification Protocol Liquid Chromatograph MASS SPECTROMETER No. : PR _A Version: 1.0 Page: 1/5 Protocols are general for each type of equipment QMP contains specific test conditions and pass-fail criteria All protocols are strictly followed during qualification. Deviations, for technical reasons, must be approved and will be documented Protocols are available for review under signed non-disclosure agreement Page 22

23 Select Multi-Vendor Compliance Customers Page 23

24 Summary Recommendations Form a validation team (include IT!) Develop validation master plan Define user requirements and functional specifications Qualify the vendor Perform and document qualifications Evaluate the need for retrospective evaluation and develop a plan Document Page 24

25 Resources Pub No EN Page 25

26 Resources GLP/GMP Primer from Agilent Technologies Basics of GLP/cGMP Impact on Laboratories Equipment validation/qualification Computer validation FDA 21 CFR Part 11 Method validation (ICH, USP) Vendor contributions Glossary Agilent Publication E Page 26

27 Resources L.Huber Validation of Computerized Analytical and Networked Systems Interpharm Press Global on-line resource for validation&compliance issues in laboratories Regulatory news Discussion forum Monthly newsletter Usersclub with free downloads Links to literature, documents and other websites Several pages dedicated to 21CFR11 Page 27

28 Agilent s Compliance Solutions Agilent was independently rated #1 for Compliance expertise Vendor-independent, global solution for all laboratory analytical instruments A responsive, experienced team focused on helping you succeed Reduced validation costs Can we partner with you? Page 28