Get Template For The Qualified Persons Declaration Concerning Gmp Compliance Of The Active Substance

Filling out the Template For The Qualified Persons Declaration Concerning GMP Compliance is essential for ensuring compliance with good manufacturing practices. This guide provides a detailed, step-by-step approach to completing the form accurately and efficiently online.

Follow the steps to effectively complete the QP declaration template.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Begin by reviewing the first section, Part A, which requires listing all relevant manufacturing sites. Ensure all tick boxes are checked and that accurate information about each site is entered.
3. Proceed to Part B, where you declare the GMP compliance of the active substance manufacturers. Choose between providing a single comprehensive declaration or multiple individual declarations based on the sites listed.
4. Move to Part C, which outlines the basis of the declaration. Indicate whether the audit was conducted by the manufacturing authorization holders or a third-party auditor, documenting the necessary details.
5. In Part D, verify the supply chain traceability of the active substances. Confirm that the supply chain is established, documented, and that risk assessments are available for inspection.
6. Complete Part E by attesting as the Qualified Person responsible for the applications. Ensure that all necessary agreements and procedures are in place and available for review.
7. Finally, save changes to the completed form online. You can also download, print, or share the form as needed.

Complete your documents online to ensure compliance and streamline the submission process.