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Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATIONProduct Name: ___DAN: ___REASSESSMENT CHECKLIST FOR VARIATION APPLICATION OF ACTIVE INGREDIENT REGISTRATION Note: Please

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How to fill out self-assessment checklist for variation

01

Review the current variation request and identify all the changes that have been made.

02

Refer to the relevant regulations and guidelines to ensure compliance with all the requirements.

03

Fill out the checklist by providing all the necessary information and documentation for each section.

04

Double-check the checklist to ensure all information is accurate and complete.

05

Submit the filled-out checklist along with the variation request for review.

Who needs self-assessment checklist for variation?

01

Companies or individuals who are applying for a variation to an existing authorization or approval.

02

Regulatory agencies or authorities who are responsible for reviewing and approving variations.

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What is self-assessment checklist for variation?

The self-assessment checklist for variation is a document used to assess compliance with regulatory requirements and guidelines for variations in a particular process or system.

Who is required to file self-assessment checklist for variation?

Any individual or entity involved in a process or system that requires variation is required to file the self-assessment checklist.

How to fill out self-assessment checklist for variation?

The self-assessment checklist for variation can be filled out by carefully reviewing the regulatory requirements, guidelines, and conducting a detailed assessment of the process or system.

What is the purpose of self-assessment checklist for variation?

The purpose of the self-assessment checklist for variation is to ensure that the process or system meets regulatory requirements, guidelines, and is in compliance with standards.

What information must be reported on self-assessment checklist for variation?

The self-assessment checklist for variation must include details of the process or system being assessed, findings of the assessment, any deviations from regulatory requirements, and proposed corrective actions.

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