You are hereBRIEF CONCEPT OF VALIDATION & CALIBRATION

BRIEF CONCEPT OF VALIDATION & CALIBRATION


Concept of calibration 20-39:

Calibration:

What is calibration?
In the simplest term calibration means to known how accurate testing and measuring instruments employed in the quality  measurement system are.

This is achieved by comparing these instruments against more precise and accurate instrument called master instruments or reference standard.

Why calibration?
Calibration brings out the nature and magnitude of an error (if any) of testing measuring instruments.

This error is the deviation from the reference standard and it is the hidden deficiency of the quality measuring system of an organization.

Advantages of calibration:
The knowledge of the nature and extent of errors of the testing and measuring the instruments employed in quality measuring system, will help an organization in the following ways:

· One can take the error of an instrument into account while using it and hence correct measurements are recorded and reported .this will help an organization to set its process and quality control system correctly.
· Wherever possible, one can adjust or repair the instrument to minimize the error to the best extent.
· Any dispute arising with a customer due   to instrument error can be resolved.

Where to get the instruments calibrated?
One should get all the testing and measuring instruments calibrated at a reputed institute or organization like RRSL, NC QC, atira etc. which has a set of precise reference standard, instruments and facilities backed by well –qualified and experienced personnel.

One can provided good most accurate and reliable calibration services with due traceability. some of them are built to provide following facilities.

  • Identification of instruments for calibration
  • At sit calibration
  • Single window calibration service
  • Calibration of special instruments
  • After calibration service:
  • If you wants to calibrate your any instruments at out side party PI.providing the following details.

- Name and type of the instruments
- Make,model and the year of manufacturing.
- Operational range with least count and accuracy.
- Relevant standards or calibration procedure.(in case of specialized critical instruments)
- General information about your organization.

CONCLUSION:
Validation is an important part of Analytical as well as Bio-Analytical Method. Procedures involved in checking data or programs for correctness, compliance with standards and conformance with the requirement specifications, During the process the knowledge of process increases, Assures the repeatability of the process, Assures the fluency of production, Assures that the product is continuously according to the marketing authorisation, Decreases the risk of the manufacturing problems, Decreases the expenses caused by the failures in production, Decreases the risks of failing in GMP, Decreases the expenses of the every  day production even though the validation itself will create expenses

REFRENCES:
Books
1.R. Albert and W. Horwitz, Analytical Chemistry, 1997, 69, pp 789-790
2.CIPAC Handbooks, CIPAC Publications, Black Bear Press, Cambridge, UK.
3.W.J. Dixon, Ann. Math. Stat.1951, 22, p 68
4.J.M. Green, A practical guide to analytical method validation, Analytical Chemistry, 1996, May 1, pp 305A/309A.
5. EC document SANCO/3030/99 rev.4 11/07/00 Technical Material and Preparations; Guidance for generating and reporting methods of analysis in support of pre- and post registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414.
6.U.S. Pharmacopoeia 25, pp 2256-2259.
7. VICH (International Cooperation on Harmonisation of Technical Requirements for registration of Veterinary Medicinal products: GL 1 – Validation of Analytical Procedures: Definition and Terminology.
8.J. Vessman et al, IUPAC, Pure Appl. Chem., 2001, 73(8), pp 1381–1386.
9. The Fitness for Purpose of Analytical Methods. A Laboratory Guide to Method Validation and Related Topics. P. De Bievre et al, EURACHEM Guidance document.
10.U.S. FDA, Title 21 of the U.S. Code of Federal Regulations:
21 CFR 211—Current good manufacturing practice for finished pharmaceuticals.
11.U.S. FDA - Guidance for Industry (draft) Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls and Documentation, 2000
12. ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, 2005
13.International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: definitions and terminology, Geneva (1996)
14. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: Methodology, adopted in 1996, Geneva
15. U.S. EPA, Guidance for methods development and methods validation for the Resource Conservation and Recovery Act (RCRA) Program, Washington, D.C. (1995)., epa.gov/sw-846/pdfs/methdev.pdf
16. General Chapter 1225, Validation of compendial methods, United States Pharmacopeia 30, National Formulary 25, Rockville, Md., USA, The United States Pharmacopeial Convention, Inc., (2007).
17.U.S. FDA - Guidance for Industry, Bioanalytical Method Validation
18. G. C. Hokanson, A life cycle approach to the validation of analytical methods during pharmaceutical product development, Part I: The initial validation process, Pharm. Tech., Sept. 1994, pp. 118–130.
19.G. C. Hokanson, A life cycle approach to the validation of analytical methods during pharmaceutical product development, Part II: Changes and the need for additional validation, Pharm.Tech., Oct. 1994, pp. 92–100.
20.J. M. Green, A practical guide to analytical method validation, Anal. Chem. News & Features, 1 May 1996, pp. 305A–309A.
21.B. Renger, H. Jehle, M. Fischer and W. Funk, Validation of analytical procedures in pharmaceutical analytical chemistry: HPTLC assay of theophylline in an effervescent tablet, J. Planar Chrom. 8:269–278 (July/August 1995).
22.Wegscheider, Validation of analytical methods, in: Accreditation and quality assurance in analytical chemistry, edited by H. Guenzler, Springer Verlag, Berlin (1996).
23.S. Seno, S. Ohtake and H. Kohno, Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry, Accred. Qual. Assur. 2:140–145 (1997).
24.AOAC Peer-Verified Methods Program, Manual on policies and procedures, Arlington, Va., USA (1998). aoac.org/vmeth/PVM.pdf
25. P. A. Winslow and R. F. Meyer, Defining a master plan for the validation of analytical methods, J. Validation Technology, pp. 361–367 (1997).
26.J.Breaux, K. Jones, and P. Boulas, Pharmaceutical Technology, Analytical Technology and Testing, 6-13, 2003
27.S.O. Krause, A Guide for testing biopharmaceuticals, Part II: acceptance criteria and analytical method maintenance, Pharm. Tech. Europe, Vol 18(6), 29/38, 2006
28. CITAC/EURACHEM, Working Group, International guide to quality in analytical chemistry: An aid to accreditation, 2002.
29.J. Vessman, Selectivity or specificity? Validation of analytical methods from the perspective of an analytical chemist in the pharmaceutical industry, J. Pharm & Biomed Analysis 14:867–869 (1996).
30.L. Huber and S. George, Diode-array detection in high-performance liquid chromatography, New York, Marcel Dekker, ISBN 0-8247-4 (1993).
31.EURACHEM – The Fitness for Purpose of Analytical Methods A Laboratory Guide to Method Validation and Related Topics, 1998
Website:
32 en.wikipedia.org/wiki/Validation
33 ich.org/products/guidelines/quality/quality-single/article/validation-of-analytical-procedures-text-and-methodology.html
34 authorstream.com/Presentation/aSGuest139631-1474998-validation-ppt/
35 slideshare.net/tjdhana/verification-validation-presentation
36 slideshare.net/banuman35/analytical-method-validation-by-pravisankar
37 slideshare.net/tjdhana/verification-validation-presentation
38 fda.gov/downloads/Drugs/Guidances/UCM070336.pdf k
39 google.co.in/?gws_rd=cr&ei=25TkUoIGjP2UBdSEgTg#q=validation+conclusion

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