Method Validation

HPLC with FLD
HPLC with FLD

Our laboratory has carried out hundreds of method validation studies for leading pharmaceutical companies in India and around the world helping them successfully register their products in various countries. We follow a systematic process for conducting validation studies so that the correct data can be submitted in a time bound manner.

We follow the following steps –

  1. The exact analytical method to be followed is shared in the form of a standard testing procedure for approval
  2. After the approval of the standard testing procedure a draft method validation protocol is developed
  3. The draft method validation protocol is submitted to the client for approval
  4. If there are any recommendations from the client these are incorporated into the method validation protocol
  5. A final method validation protocol is issued
  6. Method validation studies are initiated and carried out as per the protocol
  7. After completion of the method validation or draft method validation report is prepared and submitted to the client along with the raw data
  8. Once the client gives the go-ahead for preparation of final report the final report incorporating any suggestions a correction this prepared
  9. The final report along with all raw data as well as soft copy of the chromatographic data is submitted to the client
  10. If there are any queries from the regulatory bodies on the method validation is data submitted we help our clients answer these queries and also carry out additional experiment work if there is a need

Validation of analytical procedures used in the pharmaceutical laboratory is critical to ensure that they are suitable for the analysis is being carried out.

Analytical method validation reports form an integral part of product dossiers for the approval of pharmaceutical products and pharmaceutical substances. Nowadays all countries require that analytical method validation reports with complete chromatograms and raw data must be be submitted along with the dossiers for evaluation and approval of the products.

Method validation is defined as the generation of documented evidence which establishes the suitability of the method for its intended use. As part of the method validation a number of parameters are required to be established and must meet the globally acceptable acceptance criteria is laid down under the ICH guidelines and in various pharmacopoeia.

The table below provides a list of some of the common parameters along with their acceptance criteria which are evaluated as part of a method validation exercise.

S. NoValidation ParametersAcceptance Criteria
1.0System Suitability
% RSD NMT 10.0
2.0Limit of Detection(Signal to Noise Ratio)NLT 3:1
3.0Limit of Quantification(Signal to Noise ratio)NLT 10:1
4.0Specificity There should not be any interference between the responses of blank, sample and standard.
5.0Precision
5.1System PrecisionRSD NMT 10.0%
5.2Method PrecisionRSD NMT 10.0%
5.3Intermediate PrecisionOverall RSD NMT 10.0%
6.0Linearity Coefficient Correlation NLT 0.99
7.0Range

(Between 50 to 150 % of the specification limit)

Linear
8.0Accuracy

(Individual Recovery)

50 – 150 %
9.0Robustness
9.1Dilution Integrity

(% RSD)

NMT 15.0 %
9.2Stability

(% RSD)

NMT 10.0 %

 

 

 

 

 

 

If you have any requirement for method validation on HPLC, GC, ICP MS or any other technique including microbiology please feel free to contact us by using the quick query form on the right or you can even call us now on +91 – 11 – 45754575 and our team of experts will be happy to help you.

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