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ISTA SecretariatRichtiarkade 18, 8304 Wallisellen, Switzerland Phone: +41 44 838 60 00 | Fax: +41 44 838 60 01 Email: ista.office@ista.ch www.seedtest.orgAnnex 4: Test Method Validation Application

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How to fill out method validation programme

01

Identify the purpose and scope of the method validation programme.

02

Collect all relevant information such as method documentation, standard operating procedures, and validation protocols.

03

Perform a risk assessment to determine critical parameters to be validated.

04

Develop a validation plan outlining the validation activities, acceptance criteria, and responsibilities.

05

Execute the validation experiments according to the plan.

06

Analyze the data and prepare a validation report documenting the results.

07

Review and approve the validation report before implementation.

Who needs method validation programme?

01

Laboratories performing analytical testing

02

Regulatory agencies requiring validation of analytical methods

03

Companies seeking ISO certification

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What is method validation programme?

A method validation programme is a process that ensures that analytical methods are suitable for their intended purpose, providing reliable and consistent results.

Who is required to file method validation programme?

Organizations and laboratories that develop or use analytical methods for testing, especially in regulated industries such as pharmaceuticals, food safety, and environmental testing are required to file a method validation programme.

How to fill out method validation programme?

To fill out a method validation programme, one should provide details of the method, the objectives of validation, the parameters to be tested, data from validation studies, and the conclusions drawn from the results.

What is the purpose of method validation programme?

The purpose of a method validation programme is to establish the reliability, accuracy, precision, and overall quality of an analytical method and to ensure that it meets regulatory and industry standards.

What information must be reported on method validation programme?

The information that must be reported includes method description, validation objectives, experimental design, validation results (accuracy, precision, specificity, sensitivity), and overall assessment of method performance.

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