analytical method validation for pharmaceutical quality control

Type of analytical procedure validated

1. Identification tests.
2. Quantitative tests for impurities’ content.
3. Limit tests for the control of impurities.
4. Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product

Type analytical method validation

1. Identification tests.

Identification

First Parameter show

Identification Lets Explains

First show in Fig – 1

Second show Fig – 4

If after seen Fig – 1 identified Fig – 4 is Girl or Boy.

How to indemnified Girl or Boy?

Do some Identity Their sound, Log hair, dress etc…

Identify fig- 2 is girl

Same do In Over Pharmaceutical Product

Here we performed some test like Show fig – 3 performed test

Identification tests

1. Chemical test
2. Spectroscopic method like FTIR, NMR, Mass spectroscopy etc
3. Chromatographic techniques (TLC, HPTLC, HPLC)

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Quantitative tests for impurities’ content.

boy

After determining she was a girl, we do her marriage so performed Quantitative test for Impurity content.

Mean by observed for marrying this boy (for girl), engaging in bad habits like drinking, smoking, and other behaviors

[NOTE: Bad behavior can be beneficial to someone]

Thus, not all impurities are harmful to all products; in fact, some are beneficial.

Here, we conducted a quantitative test to determine the impurity content of the product.

UV-Visible spectrophotometer
HPTLC, HPLC
Fluorimeter
Electrochemical Method Like Conductometer, potentiometer
Flame photometer (Na, K, Ca, Mg, AAS ( Heavy metal impurity)

Limit Test

How much alcohol, cigarettes, and other harmful habits are allowed here was tested

Limit test

Arsenic
Lead
Chloride
Iron

Quantitative test for Assay content

Here, we witnessed the extent of a boy’s bad behavior, including how to treat other people badly-such as by tossing them into the hotel pool, an elderly man, or another girl.

I mean, see how his heart, honesty, and other qualities perform on the test.

Quantitative test for Assay content.

1. UV-Visible spectrophotometer
2. HPTLC, HPLC
3. Fluorimeter
4. Electrochemical Method Like Conductometer, potentiometer
5. Flame photometer (Na, K, Ca, Mg, AAS ( Heavy metal impurities)

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

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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.

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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]

<1225> USP Chapter important for method validation

Data Elements Required for Validation

CATEGORY I

Analytical procedures for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products. (Apply for preservative API)

CATEGORY II

Analytical procedures for determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products. These procedures include quantitative assays and limit tests.( Like forces degradation, and quantities test, assay, and lod, loq, mostly apply in API)

CATEGORY III

Analytical procedures for determination of performance characteristics (e.g., dissolution, drug release, and others).(Formulation plant applicable)

CATEGORY IV

Identification tests.

For each category, different analytical information is needed. Listed in Table 2 are data elements that are normally required for each of these categories. [NOTE—For detailed information regarding the validation of dissolution procedures, see the Dissolution Procedure: Development and Validation

(Such case are given bellow table whenever test might be apply)

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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)

Quantitative test for Impurity content.

- UV-Visible spectrophotometer
- HPTLC, HPLC
- Fluorimeter
- Electrochemical Method Like Conductometer, potentiometer
- Flame photometer (Na, K, Ca, Mg, AAS ( Heavy metal impurities)

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Limit test

- Arsenic
- Lead
- Chloride
- Iron

Quantitative test for Assay content.

- UV-Visible spectrophotometer
- HPTLC, HPLC
- Fluorimeter
- Electrochemical Method Like Conductometer, potentiometer
- Flame photometer (Na, K, Ca, Mg, AAS ( Heavy metal impurities)

Parameter of Method validation

Accuracy

Precision

Repeatability

Intermediate

Reproducibility

Specificity

Detection Limit

Quantitation Limit

Linearity Range

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other Q & A