About cGMP Certification
The cGMP Certification is needed by manufacturing companies to manufacture and sell food and drug related products.
The GMP, or Good Manufacturing Practices, are the guidelines that decide whether or not a company is allowed to sell their product to the general public.
These guidelines are set in place to make sure that the companies are only sending out products of high quality and items that would not put the consumer at risk.
If a company does not meet those guidelines then they will be unable to secure cGMP Certification, and would be unable to sell their product to the public.
In order for a manufacturing company to begin selling their food or drug related product, they will need to become certified through the FDA, as the FDA is the one who decides what type of quality is needed in a product before it hits store shelves.
When a manufacturing company is established, they must pass all necessary inspections of their facility, but they must also obtain cGMP certification. Even if their facilities pass all inspections, they cannot begin production until they become certified.
In order to become certified, you must complete some very important steps. These steps ensure that your company and your employees are living up to the standards set by the FDA.
Due to the number of manufacturing companies around the country, you have two different choices when it comes to obtaining your certification.
The most commonly used is certification by WHO or the World Health Organization. The other is certification through the NPA or the National Products Association. Both of these companies can certify you to begin the manufacturing process.
Let’s see what you have to do in order to be certified by WHO, as this company is the most commonly used amongst manufacturers.
The first few steps may seem to repeat themselves, but they are actually separate and are all equally important in the process of obtaining certification.
Inspections
All manufacturing companies, whether they are drug companies or food companies, must submit their facilities for inspection.
Inspections are performed by a third party team who will inspect all aspects of the facility to make sure that it is up to standard.
Assessments will be taken of the company and the facilities to make sure that everything was built according to FDA standards and the standards of WHO. If your company does not pass the inspections, then you will be denied certification.
Assessing Manufacturing Processes
Before and during your time that you are certified, your facility and your machines will be monitored to make sure that they are keeping up with FDA standards.
This could mean random visits from WHO personnel, scheduled visits, or even someone with the FDA coming by to check and make sure that you are obeying the standards.
You will be graded according to how your machines and employees are following the policies. And similar to most other things, the more you follow the policies and procedures, the higher your score will be.
Instructions from Management
Members of management are expected to post FDA policies and procedures where they can be seen by all employees.
In addition, all forms given to employees by management must be clearly written and everything they need to know about the FDA guidelines must be written plainly and in such a way that everyone can understand without question.
In the training of new employees, management must be sure that all employees have complete knowledge of the machines they will be running and also of the policies and procedures that they will be adhering to.
If they are aware of the correct procedures at all times, then they will help to ensure that the company is running at top quality all of the time.
Skilled Operators
All companies want to have employees that are skilled in their positions and are out to help make the company a better place to work.
This is especially important when you are manufacturing drugs or food items. Employers should make sure that the employees running the machines are completely skilled at their jobs and know how to hold up company standards.
Employees in the manufacturing environment should also be able to take clear and concise notes while they are on the job.
These notes should have their observations of their current assignment properly documented and forms should always be filled out completely.
By making sure that the forms are completely filled out every time, the company can ensure that their productivity and the quality of the products they are sending out is of the highest caliber.
This task may seem a little overwhelming, but if management requires it to be done on shift, then it should become rather easy after a few days of practice.
Reviewing and Addressing Complaints
Once you have begun production, you will more than likely have some type of feedback about your product from consumers.
In order to obtain and keep WHO certification, management must keep a close watch on all complaints and pull any defective batches in a timely manner.
They should also alert the public to the voluntary recall of a certain product within a timely manner to make sure that no one else receives any damaged or defective products.
cGMP Certification Review Summary
Once you have completed the list of must haves and must dos by the WHO and FDA, you will be ready to submit your application to WHO for certification.
Once you have obtained that certification, you will be given the green light to manufacture and distribute your product in the form of a COPP or a product certification form.
This simply states that your product and company has passed all of the needed requirements and that your product is up to company standards and is ready to be manufactured and distributed to the public.
While this may seem like a long and lengthy process, and it can get expensive, with certification costing around $5,000 for the first time, and around $1,000 a year to maintain that license, it is a serious requirement.
The FDA works hard to make sure that the products companies are distributing to the public are safe for them to consume. By making high quality products, companies are guaranteeing that they will have repeat customers.
