As the FDA continues to conduct its audits, several companies received warning letters or were forced to cease operations because of their inability to meet cGMP specifications. As a result, many business owners of supplements are being forced to look for a new manufacturer to help them meet their manufacturing needs. Unfortunately, many of these people may not know the questions to ask a potential supplement manufacturer.
Here are the pertinent questions you should ask your supplement provider, especially if you are starting a supplement company.
Do they outsource any of the services they advertise? You need to make sure that all manufacturing services advertised by a contracted manufacturer are performed within your own premises. Because? Any outsourced service is not under the full control of the contracted manufacturer and therefore there is a risk of compromising quality standards.
For example, if a contracted manufacturer offers storage and order fulfillment, you should be able to see where your products are being stored and ensure the environment is conducive to storage. Check how stocks are held and how fast a shipment is shipped from the time an order is issued. If a manufacturer advertises that it has an internal graphic design department, make sure that this department exists on the spot so you have direct access to your designers. The same goes for a manufacturer that advertises custom formulations and internal lab. You should be able to meet with formulators to discuss your product and check your laboratory facilities.
Do they answer calls? You need to make sure that when you call the contracted manufacturer, someone on the other side will answer your call.
A manufacturer that employs an accessible and experienced team of customer service representatives is an indication that they regard customer satisfaction, trust and lasting business relationships as top priorities. Also, if there is no one to answer your calls, how can you get your product line off the ground?
Can you take a full tour of your facility? Visit the installation / construction of a supplement manufacturer before making the decision to contract with them.
It is important that you see how the installation is hygienic. Go through the entire manufacturing process from the entry of raw materials and your inspection to the final product and shipping test.
Things to watch out for while visiting the facility:
Standard Operating Procedures (SOPs)
Specifications and Finished Product
Quality control (QC) in the areas of manufacturing, packaging, labeling, support and storage controls
Master and batch records
Ask questions such as: Does the manufacturer qualify your supplements and what are the processes that are in place to ensure the integrity of the supply chain? Ask what steps are being taken to ensure that the label specifications are in accordance with the ingredients found in the supplement. Make sure that all personnel are adequately qualified for their work. Ask them if internal audits are carried out and what steps are taken when deficiencies are identified?