GMP manufacturing is an import aspect of every supplement manufacturer that values the safety and effectiveness of its supplements and vitamins. To manufacture GMP supplements and vitamins, the company must first become a GMP certified manufacturer. If the company is not a GMP certified manufacturer, all of its supplements and vitamins are considered as adulterated, which means that the supplements are not manufactured in accordance with the conditions set by cGMP guidelines. The benefits of GMP manufacturing are demonstrated by the fact that it is difficult for consumers to detect if a supplement is safe or not through touch, smell or sight, which can only be done through testing.
Why Is GMP Manufacturing Important?
The GMP manufacturing guidelines help assure that the quality and safety of the GMP supplements and vitamins is included in the design and manufacturing process by ensuring that the employees are well trained, equipment are properly maintained and the processes are reproducible and reliable. The GMP guidelines are systems set in place to help assure proper design and monitoring as well as control of the manufacturing facilities and processes. The regulatory system requires every GMP certified manufacturer to assure the quality, purity, identity and strength of the GMP supplements and vitamins through established quality management systems and operating procedures, high-quality raw materials and reliable testing labs as well as effective product quality detecting deviations.
How to Become A GMP Certified Manufacturer
The process of becoming a GMP certified manufacturer varies greatly depending on the manufacturers unique aspects, but several requirements must be met before the GMP certificate can be issued. They include inspections, manufacturing process assessments, guidelines and procedures, skilled operators and complaints review and solutions.
To manufacture GMP supplements and vitamins, supplement manufacturers must pass the assessments and scrutiny for certification. The inspections are done by national regulatory agencies such as FDA, but manufacturers can request a third party inspection before the actual assessment by national regulatory agencies. The third party inspection helps to identify and rectify areas that need improvement to pass the actual inspection.
Manufacturing Processes Assessments
In GMP manufacturing, all manufacturing processes should be clearly defined and controlled. They should also be highly consistent to meet the standards required of GMP supplements and vitamins. Highly controlled and monitored processes ensure that the company will determine and rectify flaws that might occur during the manufacturing process in the shortest time possible.
Guidelines and Procedures
For a company to manufacture GMP supplements and vitamins, the guidelines and procedures should be clear and unambiguous for easy understanding. The procedures should also be simple, clear and precise for appropriate execution. All company employees and quality control specialists should also understand the manufacturing procedures well to perform the tasks and duties in accordance with the set standards.
Company operators must be highly qualified and familiar with the GMP guidelines for the company to be GMP certified. The guide also requires employees to have a sufficient and continuous level of training to help handle emerging issues more competently. The employees should also write down and record their observations to help assess the quality, productivity and efficiency. This process helps to ensure continuous quality and process improvement.
Complaints Review and Immediate Solutions
It is common even for certified companies to have complaints. The GMP guidelines require the certified company to examine the complaints about the products and quickly address the shortcoming by recalling the defective batches.