ISO and cGMP:
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 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 piece and key element to successfully FDA-PMTA approval of products. The FDA has not published cGMP standards for the eliquid yet, however, the cGMP will be required to ensure integrity, safety and quality of finished products. At eliquidGMP, we will guide you through the new FDA final rule to implement cGMP standard.
Some of the elements of the cGMP implementation includes:
- 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