BRIEF CONCEPT OF VALIDATION & CALIBRATION

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About Authors:
Nirav.R. Soni
M.Pharm, A-One Pharmacy College,
Anasan, Ahmedabad-382330, India
nirav_sonic@yahoo.com

Abstract:
Validation is a important part of Analytical as well as Bio-Analytical Method. The procedures involved in checking data or programs for correctness, compliance with standards and conformance with the requirement specifications. It  is establishing documented evidence, which provides high degree assurance that a specific process will consistently produce a product meeting its predetermined specification and quality characteristics. Calibration is totally differ from Validation But it is an integral part of validation.

REFERENCE ID: PHARMATUTOR-ART-2114

PharmaTutor (ISSN: 2347 - 7881)

Volume 2, Issue 2

Received On: 15/01/2014; Accepted On: 23/01/2014; Published On: 10/02/2014

How to cite this article: NR Soni, Brief Concept of Validation & Calibration, PharmaTutor, 2014, 2(2), 69-78

Introduction1-10:
Analytical methods described in Collaborative International Pesticide Analytical Council (CIPAC) handbooks and Association of Official Analytical Chemists (AOAC International) Manual for agricultural active constituents and agricultural chemical products, and in British Pharmacopoeia (BP), British Pharmacopoeia (Veterinary) [BP (Vet)], European Pharmacopoeia (Ph Eur) and United States Pharmacopoeia (USP) for veterinary active constituents and veterinary chemical products are legally recognised as the regulatory methods, and these procedures (if one is available) are used by the APVMA for determining compliance with the Agricultural and Veterinary Chemicals Code Act.

Note: Analytical methods described in CIPAC handbooks and AOAC International Manual, and in recognized pharmacopoeias [BP, BP (Vet), Ph Eur and USP] for a particular active constituent or formulation are regarded as validated and do not require revalidation. However, the suitability of these methods must be verified under actual conditions of use i.e., the selectivity and accuracy of the method should be demonstrated for the published method when applied to the relevant sample matrix and laboratory conditions.

FDA-guidelines:
“Validation is establishing documented evidence which provides ahigh degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”

EU-guidelines
“Action of proving, in accordance with GMP-principles that any procedure, process, equipment, material, activity or system actuallyleads to the expected results.”

But validation itself does not improve process but assures that the process has been properly developed and is under control.

Fundamental description1-20:

· Need for pre-determined operational & performance userrequirements (URS) of process or system
· Provide evidence of meeting pre-defined operational & perfomance requirements
· Provide evidence on consistency of meeting these requirements.

More specific6-8:

· “Methods validation is the process of
· demonstrating that analytical procedures are
· suitable for their intended use” (ICH Topic Q2B, March 1995)

Why validation 7-12?

1. GMP-legislation
2. Good economics
3. Good science practices

Validation guidelines

1. ICH Q2A
Text on validation of analytical procedures: Definitions andterminology (March 1995)

2. ICH Q2B
Validation of analytical procedures: Methodology (June 1997)

3. FDA
(Draft) Guidance for Industry: Analytical procedures and methodsvalidation

4. Pharmacopoeias
USP and European Pharmacopoeia.

What methods to be validated?

Defined for:

· identification
· quantitative tests for content of impurities
· limit tests for control of impurities
· quantitative tests for active moiety in drug substances and drug products

Referred to:

  • dissolution testing
  • particle size determination (drug substance).

When should methods be validated 12-28?
Development and tox:
No validation required

Phase 1
No validation data required.

Phase 2
For both drug substance and drug product supporting validation data on analytical methods should be available on request.

Phase 3 (Pivotal studies):
Appropriate validation information should be provided. Assay validation should cover accuracy, precision, specificity (including stress testing), quantitation & detection limits, linearity and range (where appropriate) Degradation should be identified, qualified and quantified.

Figure :-NDA submission
Full validation reports of relevant methods must be included


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