Get Ema 334808 2014

Filling out the Ema 334808 2014 form is a critical process for declaring compliance with good manufacturing practice (GMP) for active substance manufacturing. This guide provides step-by-step instructions ensuring a smooth and accurate completion of the document online.

Follow the steps to successfully complete the Ema 334808 2014 form.

1. Click the ‘Get Form’ button to access the form and open it in the online editor.
2. In Part A, enter the name of the active substance along with the detailed name and address of each manufacturing site involved in the synthesis. Ensure you list all sites beginning from the introduction of the designated starting material.
3. Continue in Part B by listing all the manufacturing/importer authorisation holders (MIAHs) applicable to your declaration. For each MIAH, provide the site name, MIAH number, and the manufacturing activity.
4. In Part C, check the box indicating completion of the on-site audit. Complete the table with the relevant MIAH site, auditing body, site audited, and the date of the audit. Provide justifications if the most recent audit occurred more than three years prior.
5. If applicable, add any supplementary supportive information in section (iii) of Part C, including results of inspections or GMP certificates issued by recognized authorities.
6. In Part D, confirm your qualifications as the Qualified Person (QP), stating your responsibility for GMP compliance. You must also affirm the availability of audit reports and documentation for inspection by authorities if requested.
7. In Part E, fill in your name, MIAH site, date, and your job title. Ensure that you sign the declaration to indicate your responsibility for the submitted information.
8. Review the completed form for accuracy and completeness. Once satisfied, save your changes, and you may choose to download, print, or share the filled-out document as needed.

Complete your Ema 334808 2014 form online to ensure compliance and facilitate efficient processing.