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How to fill out the Who Qos Pd Template online
The Who Qos Pd Template is an essential document for submitting quality assessments of pharmaceutical products. This guide provides a step-by-step approach to effectively filling out the template online, ensuring users complete each section with the necessary information.
Follow the steps to complete the Who Qos Pd Template.
- Click the ‘Get Form’ button to access the template and open it in your online editor.
- Begin with the 'Summary of product information' section. Fill in the non-proprietary name(s) of the finished pharmaceutical product(s) and the proprietary name(s). Ensure to include the international non-proprietary name(s) of the active pharmaceutical ingredient(s) along with their forms, followed by your contact details.
- Next, provide the applicant name and address, dosage form, reference number(s), strength(s), route of administration, and proposed indication(s). Ensure that all details are accurate and clearly stated.
- Continue to the 'Primary Contact' section. Enter the contact person's information, including title, postal address, email address, and phone number, ensuring that these details correspond to your specific application.
- If applicable, add the details of any additional contacts who should be communicated with regarding this application. Repeat the format used for the primary contact.
- Moving on to the 'Additional Introductory Information', summarize any related dossiers previously submitted and ensure to reference the correct numbers for easy retrieval.
- Complete the remaining sections, which involve quality assessments, stability summaries, manufacturing processes, and control details. Reference the specific guidelines for accuracy, ensuring every point is addressed clearly.
- After completing all sections, review the filled template for completeness and accuracy. Once satisfied, you can save changes, download, print, or share the document as necessary.
Start filling out your Who Qos Pd Template online today!
The Quality Overall Summary (QOS) is to provide Evaluators with an overview of the Quality information used to support the approval of the drug submission. During the review process, it is intended that the QOS becomes part of the Evaluator's review report.
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