What is Pharmaceutical Method Validation?

Pharmaceutical method validation is the scientific process that proves an analytical method is suitable for its intended purpose by evaluating accuracy, precision, specificity, linearity, detection limits, quantitation limits and robustness.

What does Pharmaffiliates offer in Method Validation services?

Pharmaffiliates performs full analytical method validation for APIs, drug substances, drug products and impurities based on ICH Q2(R1) regulatory guidelines.

How much does method validation cost?

Method validation cost depends on analytical technique, number of parameters, sample type and regulatory scope. A custom quotation is provided after reviewing project requirements.

How long does method validation take?

Typical pharmaceutical method validation can take 4–8 weeks depending on number of parameters, analytical platforms and regulatory documentation requirements.

Which regulatory guidelines are followed by Pharmaffiliates?

Pharmaffiliates validates analytical methods according to ICH Q2(R1) guidelines and supports global regulatory compliance including US FDA, EMA, MHRA and other authorities.

Can Pharmaffiliates validate a method developed by another laboratory?

Yes. Pharmaffiliates can validate methods developed externally if the method is technically suitable and aligned with validation protocol requirements.

What information is required before starting validation?

Clients must provide sample information, analytical targets, method purpose, specification limits and available method details before protocol preparation.

Do you provide Method Validation reports for regulatory submissions?

Yes, a complete validation report including all parameters, analytical results, chromatograms, calculations and raw data is provided for regulatory submission.

What are the different types of method validation parameters?

Common method validation parameters include accuracy, precision, specificity, linearity, range, robustness, LOQ, LOD and system suitability tests.

What is the difference between method development and method validation?

Method development establishes conditions to analyze an analyte, while method validation confirms that the developed method is reliable, accurate and reproducible for routine use.

Method Validation | Analytical Method Validation Services

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It involves proving that analytical methods are appropriate for their intended purpose, a key requirement set by regulatory bodies at specific phases of the drug approval process.

Pharmaffiliates typically validates test methods for

API
Drug products
Drug product containers

The process starts with a validation protocol, thoughtfully reviewed and signed by both the client and Pharmaffiliates. Our team then carries out the lab work carefully, strictly following the agreed method to ensure every step meets your expectations.

Frequently Asked Questions on Method Validation

It involves proving that analytical procedures are appropriate for their intended purpose — demonstrating specificity, accuracy, precision, linearity/range, detection & quantitation limits, and robustness under a mutually agreed protocol. :contentReference[oaicite:1]{index=1}

Pharmaffiliates can validate analytical methods for APIs (active pharmaceutical ingredients), finished drug products, and even drug-product containers as required. :contentReference[oaicite:2]{index=2}

First, a validation protocol is drafted and signed by both customer and Pharmaffiliates. Then the lab work is carried out strictly according to the agreed protocol. :contentReference[oaicite:3]{index=3}

Because method validation ensures that the analytical method consistently produces reliable, accurate and reproducible results — which is critical for regulatory compliance, correct impurity profiling, stability testing and quality control. :contentReference[oaicite:4]{index=4}

You receive a full validation report including all tested parameters (specificity, precision, accuracy, limits, robustness etc.), details of test conditions, results, and any raw data or chromatograms/spectra — enabling regulatory or QC use. :contentReference[oaicite:5]{index=5}

Yes — as long as the method is fully described, Pharmaffiliates can validate it, provided the protocol is agreed and suitability is confirmed in their lab environment. Their validation service is not limited to methods developed internally. :contentReference[oaicite:6]{index=6}

Pharmaffiliates supports a full range of modern analytical methods — from chromatography (HPLC/UPLC, GC, etc.) to spectroscopic and mass-spec techniques, enabling impurity profiling, assay, stability-indicating tests, and more. :contentReference[oaicite:7]{index=7}

Yes — because validation is designed to meet the requirements set by regulatory bodies (e.g. those based on guidelines like ICH Q2(R1)) to ensure that analytical methods are “fit for purpose.” :contentReference[oaicite:9]{index=9}

If the method fails a validation parameter, Pharmaffiliates will review and optimize the method (or adjust conditions), then re-execute validation experiments until the method meets acceptance criteria — ensuring it becomes reliable and compliant.

You need to provide details about the sample type (API, drug-product, container), intended analytes, intended use (assay, impurity, stability testing etc.), expected concentration ranges, and any existing method or specifications — then Pharmaffiliates will draft and share a validation protocol for your approval.