Get Quality Information Summary (qis)

Filling out the Quality Information Summary (QIS) is a crucial step in preparing product dossiers for prequalification. This guide provides clear and supportive instructions to help users complete the QIS online effectively.

Follow the steps to fill out the QIS accurately.

1. Click the ‘Get Form’ button to access the QIS template and open it in your preferred editing tool.
2. Begin with the summary of product information. Fill in the non-proprietary and proprietary names of finished pharmaceutical products (FPP), the international non-proprietary names of active pharmaceutical ingredients (APIs), and include details about the applicant’s name and address. Remember to select the appropriate dosage form and provide the respective strength and route of administration.
3. Proceed to the administrative summary section. Indicate the applicant's date of preparation or revision of the QIS, specifying the internal version or acceptance date.
4. In the subsequent sections, provide details about related dossiers, such as reference numbers and confirmation of prequalification for APIs. Ensure that all information regarding API manufacturers and their respective details is completed accurately.
5. Complete the sections related to drug substances and drug products, including specifications, control measures, and stability summaries. Enter precise values and components as described in the guide.
6. After filling out all relevant sections, review the document carefully for accuracy. Save any changes made to the form for your records.
7. Once you have finalized the form, you can choose to download, print, or share the completed QIS as needed. Ensure to keep a copy for future revisions or assessments.

Complete your documents online and ensure compliance with regulatory requirements.