It’s been over a year since the last installment of Current Good Manufacturing Practices (cGMPs) designed to increase and control the quality criteria of the dietary supplement market. Afterward, the FDA has taken significant measures to ensure supplement makers completely execute the cGMPs. Since the FDA continues to run its own audits, many companies have been issued warning letters or have been made to stop their operations due to their inability to satisfy cGMP specifications. Because of this, many nutritional supplement company owners are being made to hunt for a new manufacturer to assist that may help them fulfill their production requirements. Unfortunately though, a number of these individuals may not understand the questions to ask a possible nutritional supplement maker.
Here are five pertinent questions that you must be asking your potential nutritional supplement contract maker, particularly if you’re beginning a supplement firm.
Do they outsource some of the services that they market? You want to be certain that all of the manufacturing services that a contract manufacturer advertises occur inside their particular facility. Why? Any service that’s outsourced doesn’t come under the full supervisory charge of the contract maker, and consequently there’s threat of quality criteria being compromised.
As an example, if a contract maker provides warehousing and order fulfillment, you need to be able to see where your goods are being saved and be certain the environment is conducive to storage. Assess how stocks are preserved and how fast a shipment is discharged in the time that an order is issued. If a producer advertises that they have an in-house graphic design section, you must be certain that this section is present on the assumptions so you have direct access to their own designers. The same is true for a producer who advertises custom formulas and in-house laboratory. You ought to be able to meet up the formulators to go over your product and take a look at their laboratory center.
Do they answer calls? You want to be certain that, when you telephone your contract maker, somebody on the opposite end will answer your telephone.
A manufacturer that uses an accessible and educated group of customer service agents is a sign that they see client satisfaction, confidence and lasting business relationships as top priorities. In any case, if there is no one to respond to your requirements, how do you get your goods line off the floor?
Can you really take a comprehensive tour of the facilities? Tour the facility/building of a supplement maker prior to making a choice to contract together.
It is essential that you observe how sterile the centre is preserved. Proceed through the whole manufacturing process from the entrance of raw materials and their review to the testing of the end goods and shipment.
Things to watch while touring the center:
Standard operating procedures (SOPs)
Specifications raw material and finished product
Quality control (QC) in the areas of production, packaging, labeling, holder and storage controllers
Master and batch documents
Ask questions like: Why does the producer qualify its nutritional supplements and what are the procedures which are in place to guarantee integrity of the distribution chain? Ask what measures have been taken to make sure the specifications on the tag meets with the components found in the nutritional supplement. Ensure all employees are appropriately qualified for their tasks. Ask them if internal audits are done and what actions are taken when deficiencies are identified?
Do they display in trade shows? You ought to be able to see your present or potential nutraceutical manufacturer display at trade shows.
Major supplement producers will exhibit in industry-related trade shows frequently to market company, reach prospective customers, gain media attention, maintain business trends/latest improvements, network with sellers and build relationships with other people in the business. Supplement makers not displaying at trade shows might not be valid or just might not have the infrastructure to manage larger business opportunities. In any event, not having a presence at trade shows is usually not a fantastic sign. For more information click ISO 9001 consultant
Is your potential contract manufacturer from the media? Make sure the supplement maker you intend to utilize has a decent picture in the business and continues to be in business long enough to set a well-known standing for producing high-quality merchandise.
Have a look at social networking websites by Googling the maker. Read through others in the business need to say regarding the maker on message boards, forums and blogs. Request members in such online communities if they’ve learned about the manufacturer you’re thinking about and what their ideas are. These folks are usually educated, unbiased and experienced so their input whilst not a critical factor, can be valuable for you as you make your choice.
Read industry publications like Nutritional Outlook, Natural Products Insider, etc. to check if the maker is conducting advertisements.
You also might want to discover if they’ve won any significant awards and confirm that this information by talking directly with the magazine or other trusted news sources. Moreover, you might want to check out business positions in Inc. 500|5000 to determine whether the business is in good financial position. The very last thing you need to do is contract with a nutritional supplement maker that is on the point of moving out of business.
Third-party GMP-certification offers added assurance
Ensure that you are thoroughly happy with the working processes, documentation, QC and QA procedures and the actions required to completely comply with cGMPs. If a contract maker is currently GMP-certified with a third party like the NNFA, there’s a sufficient guarantee that the production facility has the necessary procedures in place to comply with cGMPs. Such producers may supply you with a long-lasting partnership for generating high-quality nutritional supplements economically, fast and with a high level of focus on superior excellent manufacturing.