Analytical Method Validation

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Its is importance part of analytical chemistry, here give step – by – step how to make analytical a protocol method validation.

about app

- Give briefly describe ICH Guideline for analytical method validation
- Give Routine life example give to easy understand basic concept.
- Analytical chemistry method validation Interview Question and answer
- Vedio supporting
- pharama interview question and answer give your for better understand concept
- Also you can put our question in chat or text box author will give answer as possible.

- Draft copy will give you for your self practices and good to go for pro - method validation master.

App feature routing example mean:
one of the example will discuss here

- Specificity (only Just Read )
- Definition
Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present. Typically these might include impurities, degradants, matrix, etc.

[Example marriage Life: When Girl age around 25 year parent will seen boy for her marriage Parent will seen that or find Nature of boy (Bad habit or Good habit), property etc


This example compared with Specificity assess unequivocally the analyte (Bad Habit or Good Habit) in the
presence of components (Boy) which may be expected to be present. Typically these might(drink cigarette, wine etc) include impurities, degradants, matrix, etc. ]

it is just one example give you and many more give this app

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Type of validation in pharmaceutical industry?
1. Cleaning validation
2. Process validation
3. Equipment validation
4. Method validation

Before start analytical method validation we have to understand some basic term

Q2A: Text on validation of analytical procedure and
Q2B: validation of analytical procedure: Methodology

Previously two guidelines coded Q2A and Q2B, which was unified to Q2(R1) guideline Nov 2005.

Summary

Method validation is given an information about analytical measurement like
· Provides information on procedure
· For analyst (the user of the procedure)
· For customer (the
· user of the results)
· Regulatory requirement
· ISO 17025 requirement
· Verifying system suitability
· For submission to compendium
· Documentary Avoidances

Before start method validation considerations of prior requirement

Suitability of Instrument
Check qualification and calibration
Suitability of Materials
Check References standard, reagents and more
Suitability of Analyst
Check Training record and qualification record
Suitability of Documentation
Approve protocol or SOP with pre-establish acceptance criteria.

Regulatory requirement:

ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and
Methodology
<1225>VALIDATION OF COMPENDIAL PROCEDURES

Other pharmacopeia chapter:

〈1224〉 TRANSFER ANALYTICAL PROCEDURES
[ Note: Transfer between laboratory to laboratory]

<1225>VALIDATION OF COMPENDIAL PROCEDURES
[ Note: Chromatography focus this chapter]

<1226>VERIFICATION OF COMPENDIAL PROCEDURES
[ Note: Method suitable and time implement]

Objective

Type of analytical procedure validated

· Identification tests.
· Quantitative tests for impurities' content.
· Limit tests for the control of impurities.
· Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product

Identification tests

· Chemical test
· Spectroscopic method like FTIR, NMR, Mass spectroscopy etc
· Chromatographic techniques (TLC, HPTLC, HPLC)

Što je novo

ICH guideline Q2(R2)