Due to the current  public health emergency posed by COVID-19, the FDA has established a temporary policy allowing certain entities who are not currently regulated by the FDA to prepare alcohol-based hand sanitizers for the duration of the public health emergency. If businesses plan to continue making hand sanitizer past the temporary FDA policy changes brought by COVID-19, they will need to meet original FDA requirements. To ensure your business has allotted appropriate time to make the necessary business updates for future FDA requirements, you need to act now and plan for the change. Many businesses will start the process of transitioning to the original requirements around the same time of the decline of the public health emergency, causing an influx of processing on the side of the FDA. Don’t allow your business to get stuck in a virtual waiting room trying to ensure the continuation of your hand sanitizer manufacturing, get ahead of the curve today.

What can Labtopia do to help you get ahead?

Labtopia provides full consulting support to organizations wishing to seek or maintain FDA GMP compliance. Labtopia’s consulting services consist of partial or turn-key solutions for every aspect of the quality assurance system. We offer customized solutions based on your specific needs and scope of work. Services include:

  • Assistance with Registration of the Establishment with the FDA
  • Assistance with Submitting Required Documentation
  • Ensuring Labeling Compliance
  • Interpretation of Monograph Requirements to Ensure Compliance
  • Assistance with Adverse Advents Reports to the FDA
  • Implementation of Good Manufacturing Practices (GMPs)
  • Internal Audits
  • Supplier/Vendor Qualification Audits
  • Accreditation Audit Support
  • Development of Corrective and Preventive Action Systems
  • Technical Writing
  • Manuals
  • Required Operating Procedures
  • Work Instructions
  • Document Control
  • Training
  • Corrective and Preventive Action Management
  • Interim and Part-Time Quality Assurance Support

Don’t Wait… Contact Labtopia today to help your business meet current requirements and prepare for future changes!