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Preparation of rh-Insulin National Reference standard. National Institute of Biologicals Noida E-mail: [email protected] Meeting of the Manufacturer’s March 20, 2009. rh-Insulin Reference Standard . WHY the need

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preparation of rh insulin national reference standard

Preparation of rh-Insulin National Reference standard

National Institute of Biologicals

Noida

E-mail: [email protected]

Meeting of the Manufacturer’s

March 20, 2009

slide2

rh-Insulin Reference Standard

WHY the need

  • There is no National Reference Standard available in our country on rh-Insulin with any metrological trace ability as per ISO guidelines –17511.
  • The certificate of Analysis also varies from one Manufacturer to another as there are no guidelines and Recommendations laid down for National Reference standard of rh-Insulin incorporated in “ Indian Pharmacopoeia”
  • International biological standards are the “Primary standards” against which Secondary standards are calibrated. Secondary standards may be -
    • National standard ,
    • Regional standard,
    • Working Reference material .
slide3

CALIBRATION HIERARCHY & METROLOGICAL TRACEABILITY

M

E

T

R

O

L

O

G

I

C

A

L

T

R

A

C

E

A

B

I

L

I

T

Y

International conventional reference measurement procedure by International Scientific organization, WHO a

International scientific organization:

WHO, NIBSC, USP

International conventional Calibrator b

Manufacturer’s selected measurement procedure c

Manufacturer’s Working calibrator d

Manufacturer’s standing measurement procedure e

Manufacturer’s Product calibrator f

End User’s routine measurement procedure g

Manufacturer

Or end user

Routine Sample h

End user

RESULT i

End user

Source

ISO 17511-2003, First edition , 2003-08-15

memorandum of understanding
Memorandum of Understanding
  • All the information of API-bulk material supplied during the study will be treated as confidential and proprietary to the manufacturer’s.
  • A MoU will be developed between

a) NIB ,

b) Industry and

c) IPC

  • All persons involved herein by signing the agreement confirms that there is no financial or vested commercial interest.
steps in establishing national reference standard
Steps in establishingNational Reference standard
  • Incorporation of human Insulin National Reference Standard in IP-Monograph for Human Insulin
  • Provide collaborators with set of necessary documents
  • Establish –

3.1Inter laboratory” collaborative study for selecting a Candidate RS material

3.2 coded material to be distributed maintaining confidentiality

33Proficiency testing program based on NABL 162 guidelines

intended use
Intended Use
  • Quantitative uses in assays of rh-insulin bulk & formulation, either by:
      • Biological methods
      • Physiochemical method-HPLC
  • Quantitative uses in Limit tests by Physiochemical method-HPLC
  • Qualitative uses in Identification tests, system suitability tests, chromatographic peak markers
  • Method development , evaluation of method performance
goals of collaborative study
Goals of Collaborative study

Selection of rh-insulin Candidate material

Obtain API-Bulk material from a major manufacturer of rh-insulin

Detailed rh-insulin testing Protocol to include elements of :

  • Type of tests
  • No of tests
  • No of collaborators
  • Elements of validation
  • No. of replicates
  • References to the procedure to be used.
  • Data recording forms for result compilation

Material is Calibrated and Characterized, with regular use of CRM

Statistical control in design and Analysis of Results

Assign Property values and Uncertainties

assignment of property values and their uncertainties
Assignment of Property Valuesand Their Uncertainties
  • Investigation of statistical outliers and/or use of robust statistic
  • Methods used to assign uncertainties to property values
  • Acquire time-zero information for future continued-suitability for use of rh-insulin Reference standard
  • 1 Unit of Human insulin =0.0347 mg by definition (28.8 IU/mg).
  • Value is assigned to rh-insulin bulk in IP.
  • Need to Work Out: Assignment of Property Value to serve as Standard for Assay of 40 IU and 100 IU Insulin preparations.
slide10

Lead Role of Collaborators

Calibrationtest as per requirements of IP-2007 & USP

Characterization test on Candidate Reference material as per requirements of IP- 2007 & USP

Characterization

IdentificationRP-HPLC

Peptide map

Purity

% related compounds RP-HPLC

% insulin aggregates SE-HPLC

work progress in the study
Work Progress in the study
  • NIB has received rh-insulin working Ref material from Four manufacturer\'s
  • Material received :
    • powder and liquid form
    • 4 vials or ampoules from each
    • Certificate information from 3 manufacturer
  • NIB has initiated Calibration using:
    • Certified Ref material-NIBSC & USP
    • Method –Potency , USP, EP as per Manufacturer CoA
    • Method –Potency -IP not given in Manufacturer’s CoA
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