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How do I fill this out?
To fill out this application, begin by gathering all necessary information regarding your manufacturing site. Ensure you have details about your products and representatives ready. Follow the outlined sections carefully for accurate submission.
How to fill out the Good Manufacturing Practice Inspection Application?
1
Gather information needed for the application.
2
Complete each section as instructed.
3
Provide details about your manufacturing site.
4
Attach any required documents.
5
Review the application before submission.
Who needs the Good Manufacturing Practice Inspection Application?
1
Pharmaceutical manufacturers require this form to comply with national regulations.
2
Local representatives use it to oversee drug manufacturing processes.
3
Quality assurance teams need the form to prepare for inspections.
4
Regulatory compliance officers utilize it for maintaining standards.
5
Business managers of pharmaceutical facilities require it for operational audits.
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What are the instructions for submitting this form?
To submit this application, send it via email to ndaug@nda.or.ug or fax it to +256-414-347391. Alternatively, you can mail it to the National Drug Authority at Plot No. 19, Rumee Towers, Lumumba Avenue, P.O. Box 23096, Kampala, Uganda. It is advisable to keep a copy for your records.
What are the important dates for this form in 2024 and 2025?
The application must be submitted in line with NDA guidelines for inspections. Be aware of annual review dates for your facility. Maintain updates for revisions as necessary.
What is the purpose of this form?
The purpose of this form is to ensure that pharmaceutical manufacturing facilities comply with Good Manufacturing Practices set by the National Drug Authority. It provides a structured process for inspections to uphold product quality and safety. By completing this application, facilities can maintain their operational licenses and ensure consumer safety.
Tell me about this form and its components and fields line-by-line.
- 1. Particulars of the Applicant/License Holder: Sections for applicants to provide their name, address, and contact details.
- 2. Particulars of Manufacturing Site to be Inspected: Details of the site being inspected including address and contact.
- 3. Contact Person on Site: Information for the designated contact during inspection.
- 4. Authorised Representative/Agent in Uganda: Details of local agents representing the facility.
- 5. Type of Medicines: Selection of medicines manufactured at the facility.
- 6. Registration of Products in Uganda: Sections to indicate if products are registered or pending registration.
- 7. Inspection Applied for: Checkboxes for different types of inspections requested.
- 8. Major Site Changes Since Last Inspection: Summary of significant changes made since the last inspection.
- 9. Production Lines to be Inspected: List of production lines available for inspection and their details.
What happens if I fail to submit this form?
Failure to submit this form may result in compliance issues with the National Drug Authority. Such negligence can lead to penalties or operational disruptions. Ensure timely submissions to maintain manufacturing licenses.
- Regulatory Compliance: Without submission, facilities risk non-compliance with local regulations.
- Operational License: Failure to submit could jeopardize the facility's manufacturing license.
- Inspection Delays: Non-submission may lead to unnecessary delays in inspections.
How do I know when to use this form?
- 1. Application for Initial Inspection: To initiate the inspection process for new manufacturing operations.
- 2. Routine Re-inspection: For routine checks to ensure ongoing compliance.
- 3. Post-Failure Re-inspection: When a previous inspection identified failures that need to be addressed.
Frequently Asked Questions
What is the purpose of this application?
This application is for requesting inspections of pharmaceutical manufacturing facilities to ensure compliance with GMP.
How can I edit the PDF?
You can edit the PDF directly within PrintFriendly by selecting the text you want to change.
Who should fill out this form?
The form should be filled out by the licensed pharmaceutical manufacturer or their authorized representative.
What if I miss a section?
Ensure all sections are filled accurately before submission to prevent delays.
Can I save my changes?
You can download the edited version of your PDF after making changes.
Is there a deadline for submissions?
Submission timelines may vary, so check with the NDA for specific deadlines.
What should I do if my application is denied?
Contact the NDA for clarification and guidance on rectifying any issues.
How do I attach supporting documents?
You can attach any required documents when submitting the application.
Can I use this form for multiple sites?
No, a separate application needs to be filled out for each manufacturing site.
Where can I send my completed application?
You can submit your completed application via email or physical mail as shown in the instructions.
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