The FDA Final Rule 21CFR Part 1100, 1400, and 1430 mandates all e-liquid manufacturers to comply with good manufacturing practices. Eliquid Compliance will establish a Quality Management System (QMS) to conform to contemporary regulatory requirements including ISO 9000 certification. In addition, we are experienced with developing and implementing streamlined, cost-efficient quality plans for new and exiting businesses.
The implementation of Current Good Manufacturing Practices (cGMP) is considered one of the critical pieces and key elements to successfully FDA-PMTA approval of products. The FDA has not published cGMP standards for the e-liquid yet, however, the cGMP will be required to ensure the integrity, safety, and quality of finished products. At eliquidGMP, we will guide you through the new FDA final rule to implement the cGMP standard.
Some of the elements of the cGMP implementation include:
• Evaluate the current manufacturing facility need to implement a cGMP
• Establish A Quality Management System (QMS)
• Establish Documentation and Records Quality System
• Product Design and Validation
• Employees training
• Customer complaint and product recalls…and more