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									  IDMA-IPC-USP 9th Annual Scientific Meeting
                                   February 18, 2010
                                  Hyatt Regency Hotel
                                     Mumbai, India


       Track I: Measurement Science
           General Approaches


Quality Standards for Medicines, Supplements, and Food Ingredients throughout the World
          Track I: Measurement Science
          General Approaches

• Traceability                        Dr. Bill Koch, USP

• Certified Reference Materials       Dr. Barb Jones, USP

• Chiral Chromatography Separations   Mr. Ch. Lakshmi Narayana,
                                       Diacel Chiral Technologies

• Indian Industry Perspective         Mr. P. Raghu Ram, Shasun

• Impurity Profiling of Drugs         Dr. K. Shivram, Sun Pharma
               IDMA-IPC-USP 9th Annual Scientific Meeting

                                    February 18-19, 2010
                                    Hyatt Regency Hotel
                                       Mumbai, India


                                    Traceability
                           William Koch, Ph.D., FACB
                Chief Standards Acquisition and Metrology Officer
                         U.S. Pharmacopeial Convention


Quality Standards for Medicines, Supplements, and Food Ingredients throughout the World
USP Mission


   … To Improve the Health of
People around the World through
 Public Standards and Related
 Programs that Help Ensure the
 Quality, Safety, and Benefit of
     Medicines and Foods.
    Why is a Public Standard Important?

• Assure a consistent approach to quality for pioneer and
  generic products

• Assess the quality of drug products in commerce

• Provide specifications that new manufacturers can target

• Monitor for counterfeit and substandard products

• Monitor the quality of imported drug products

• Provide information for compounding pharmacists

• In other words, to assure quality and consistency
  across time, space and technology.
        About the Phoenicians …

The ancient Phoenicians invented a primitive BALANCE
    made from wood and cloth to assure equity in trade
   Quality Is Assured by Measurement


"In physical science, the first essential step
in the direction of learning any subject is to
find principles of numerical reckoning and
 practicable methods for measuring some
         quality connected with it.


          ~ Lord Kelvin (1883) ~
      Metrology

• The Science of Measurement embraces both experimental
  and theoretical determinations at any level of uncertainty
  in any field of Science and Technology.

   – Fundamental metrology includes the establishment of
     measurement units, new measurement methods, realization of
     measurement standards and the transfer of traceability.

   – Applied metrology concerns the application of measurement
     science to manufacturing, ensuring the suitability of
     measurement instruments, their calibration and quality control
     of measurements.

   – Legal metrology concerns regulatory requirements of
     measurements and measuring instruments.
All Measurements are Comparisons
   Comparisons and Traceability

Lab A makes measurements of Property “Y” in a Test Sample (TS)
          by comparing TS to Lab A’s private standard


          Private
   A      Std - A
                     TS                    YA = fA (xA)
            xA




    Where Std is a standard and TS is test sample
    Comparisons and Traceability

Lab A and Lab B each make measurements of Property “Y” in a test
                sample using different standards


            Private
    A       Std - A
                      TS                    YA = fA (xA)
              xA



            Private
    B       Std - B
                       TS                   YB = fB (xB)
              xB

        There is no basis to compare YA and YB
     Where Std is a standard and TS is test sample
         Traceability

If Lab A and B make additional measurements by comparing their
private standards to a common public standard, then …



                Private
          A     Std - A
                           TS                   YA = gA (X0)
Public
 Std
                Private
  X0      B     Std - B
                           TS                   YB = gB (X0)



 YA and YB are now traceable to the same reference, X0
    Traceability

Metrological Traceability
• property of a measurement result whereby the
  result can be related to a reference through a
  documented unbroken chain of calibrations, each
  contributing to the measurement uncertainty
(fromInternational Vocabulary of Metrology - Basic and General Concepts
   and Associated Terms (VIM): 3rd Edition 2007)


• thereby allowing/enabling consistency and
  comparability of measurement results across
  time and space and technology.
          National Traceability Chain

Selected SI Coherent                              SI Base Units
Derived Units
                                   SI             meter
frequency
                                                  kilogram
force
pressure, stress                 NIST             second
                                                  ampere
electromotive force
                                                  kelvin
electric conductance
Celsius temperature
                                  USP             candela
                                                  mole
catalytic activity

                            Calibration Labs


                       Routine Measurement Labs
   Uncertainty

Measurement Uncertainty
   Non-negative parameter characterizing the dispersion
   of the quantity values being attributed to a
   measurand, based on the information used.

(fromInternational Vocabulary of Metrology - Basic and General Concepts
   and Associated Terms (VIM): 3rd Edition 2007)




   Measurement Uncertainty is inherent to and a
  necessary consequence of every measurement.
                             Metrology: Applied to Pharmaceuticals
                                   Material              Value Assignment              Procedure
                                                                 Result

                              Manufacturer’s product                                  Routine measurement
                                    sample                                                  procedure


                              Manufacturer’s working                                 Manufacturer’s working
                                    standard
               Uncertainty
Traceability




                                                                                     measurement procedure


                                  Manufacturer’s
                                                                                     Manufacturer’s reference
                                reference material
                                                                                     measurement procedure


                                 USP Reference
                                                                                        USP Compendial
                                   Standard
                                                                                           Method

                                         Certified Reference
                                                Material                    Primary Reference
                                                                          Measurement Procedure


                                                        Defined Unit of Measurement
           Results - CCQM-P20.e.2


                              Theophylline content of CCQM-P20.e.2
Mass fraction (mg/g)




                       1000

                       990

                       980

                       970
                              P1




                              P2
                             PM
                              b2
                              b3
                              b6


                              b5




                              b4


                              b1


                              b9
                              b7
                              b8
                               1




                               0
                            b1




                            b1
                           US




                           US
                           La
                           La
                           La


                           La




                           La


                           La


                           La
                           La
                           La
                           BI
                          La




                          La
                Gravimetric Reference Value = 983.1 ± 1.5 mg/g
    More Glossary Terms and Concepts


• Comparability
• Compatibility
• Bias

• Mean Values
• Measurement Results = Mean and Uncertainty
Certified Reference Materials (CRMs)

A Certified Reference Material is a Material:
 Sufficiently homogeneous and stable with reference to
  specified properties;
 Established to be fit for its intended use in measurement;
 Accompanied by documentation;
 Issued by an authoritative body; and
 Providing one or more specified property values;
 With associated uncertainties and traceabilities;
 Using valid procedures.

(from International Vocabulary of Metrology - Basic and General Concepts and
    Associated Terms (VIM): 3rd Edition 2007)
Certificate of Analysis (COA)
CRM New Releases
Realms of Specifications & Measurements

               Acceptance Criteria


                Release Specifications


                                                   Manufacturing
                  Process Variability



         Analytical Measurement and Uncertainty




              Certified Reference Material
                                                  Measurement




                  “Trueness”
    A Vision for Metrology at USP


• A Reference Standard and its associated
  Monograph for every medicine, food chemical, and
  dietary supplement in global commerce

• International recognition, harmonization, and
  official acceptance of all USP Reference
  Standards

• Cutting-edge Standards, including CRMs and
  PBMs, based on sound, scientific, metrological
  principles
                         Thank You

Quality Standards for Medicines, Supplements, and Food Ingredients throughout the World

								
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