Since the final rule was issued in June 2008 by the FDA (21 CFR 111),for the manufacturing and packaging cGMP’s, the industry has had plenty of time to address the many issues that were responsible for plaguing the public with substandard and frequently dangerous products, that in some cases were contaminated with pesticide residues. As with other life science processes & products regulated by the FDA, the basic premise has been to assure that proper controls are in place so that they can be processed in a consistent manner to meet agreed-upon quality standards and specifications. These rules and regulations do apply to all domestic (US), and foreign companies, and they apply to the whole manufacturing process, to ensure product consistency in terms of identity, purity, strength and composition. To achieve these requirements the company would need provisions to assure:
- Properly constructed plants and facilities.
- Effective cleaning methodologies for changeover campaigns.
- Well defined manufacturing controls including packaging and labeling.
- Appropriate quality control procedures and other documentation.
- Testing of products, intermediates/in process materials, as well as incoming raw materials.
- A mechanism to handle consumer complaints.
- Maintenance of other appropriate records.
In putting these rules in place, the FDA were reasonable in terms of the time they were going to allow for how they intended to regulate the manufacturers and suppliers. For small companies of less than 20 employees, the FDA made an allowance of two years to comply with the new ruling and one year for those companies having 500 or more employees.
Although it is now a decade since this was enacted, there are still cases of significant quality issues which are being reported. To draw attention to this, we’ve highlighted key/important points that are needed for the manufacture of Dietary supplements, to help to raise the awareness of these problems. It is important that manufacturers, whether they are their own manufacturers, or through a contract manufacturer, to assume responsibility for assuring that the products shipped to the consumer are unadulterated and are correctly labeled to maintain safety.
In order to meet this, there are a few basic requirements of these include:
- The company must be using qualified employees and experienced management to make the products. These individuals should be wellversed in cGMP compliance and what is required to maintain that status.
- The design of the facility and equipment used to make the supplements should be appropriate to enable consistency of processing and guarantee no adulteration of the product.
- Suppliers should be qualified, and this should be controlled as part of a Quality Management System to assure consistency of supply of raw materials.
- Appropriately detailed manufacturing and control instructions/records should be in place to assure reproducible manufacturing.
- The manufacturer should assure that all their processes used in manufacturing have undergone appropriate validation.
- Adequate QC test procedures for the raw materials and products must be in place.
- It is important to establish a Quality Management System to assure integration of quality system elements such as those associated with supplier qualification, validation and change control.
- It is necessary to arrange and establish appropriate environmental controls for the production and testing functions in order to be able to maintain consistency of processing and consistency of the product.
- Good sanitation must be maintained around the facility and there should be appropriate cleaning procedures in place to assure lack of crosscontamination as products are made during campaigns.
- There needs the be a product complaint system established that assures that all complaints are properly investigated to root cause and that corrective actions will be put in place to prevent reoccurrence.
- It is important to determine the stability of the products being distributed in order to maintain shelf life integrity.
- It is necessary for them to assure appropriate product labeling for each of the products, displaying the expiration dating for that specific product.
- As part of the Quality Management System, there needs to be the maintenance of all the records pertaining to a particular product, at least for one-year post shelf life of the product or two years past the last distribution cycle for batches associated with a particular set of records.
From experience, we notice that one area of weakness is associated with maintaining qualified vendors raw materials. In many cases there are no Quality Management Systems available for this and no vendor qualification program as part of the system. Given the often-seen inadequacy for this type of function, it is recommended that companies consult with a qualified consultant to avoid running in to these costly mistakes.