Yesterday, I discussed two basic product specifications that are essential in the contract manufacturing process. Now, I offer the others that our company uses.
Finished Good Specifications (21 CFR 111.70(e))
Finished product specifications detail the dietary supplement finished batch testing requirements. Every claimed dietary ingredient listed on the Supplement Facts Panel (SFP) must be addressed on the finished product specification, and each must have an appropriate minimum test acceptance criterion that meets each product specification for identity, purity, strength, composition, and for limits on contamination. To determine whether one or more product specifications are met, dietary supplement manufacturers must test or examine either: (1) a subset of finished dietary supplement batches identified through a sound statistical sampling plan (skip-lot or a reduced frequency testing plan); or (2) every finished batch.
It is expected that the claimed SFP ingredients meet at least 100 percent of the label claim in order to meet the requirements in the Nutritional Labeling and Education Act (NLEA) detailed in 21 CFR 101.9. Release specifications may be set at a higher percentage to account for any needed overage amounts formulated into the product to ensure the 100-percent requirement is met throughout the product expiration date cycle.
There is a limited exemption that is allowed for an ingredient(s) that is not able to be tested (un-testable item) to be exempted from verification if there is no scientifically valid test method available. In such a case, FDA requires manufacturers to “document why, for example, any component and in-process testing, examination, or monitoring, and any other information, will ensure that such exempted product specification is met without verification through periodic testing of the finished batch[.]” Id. at § 111.75(d)(1).
The release of a finished good for sale means the quality group has issued a COA for the finished product, which shows the actual results of the testing (against specifications).
Packaging / Labeling Specifications (21 CFR 111.70(d), (f), (g))
Two basic specifications are required:
1. Setting the appropriate specifications of physical components and then examining the packaging and labels for each batch of dietary supplement, before conducting packaging and labeling operations, to determine whether the packaging and labels conform to the master manufacturing record.
2. Setting process and control specifications (using a MMR), because you are required to fill, assemble, package, label, and perform other related operations in a way that ensures the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Packaging specifications (simplistic) needed for supplement packaging:
• Type of components to be used (e.g. bottle, cap, seal, fill, band, box, carton, etc.)
• Type of item to be packaged: softgels, capsules, tablets, or powder
• Quantity of per unit (e.g., 90 ct) & quantity to be packaged
• Labeling requirements (full wrap or front/back) & date/lot code requirements
• Case pack out (quantity of FG units per shipper case)
• Child-Resistant packaging required? packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly.” (e.g., Iron or any other toxic products).
Physical label (dimensions, stock type, colors. etc.)
Label roll specifications (wind, core, gap, etc.)
Label approval by quality before use
Setting sound and accurate specifications can prevent one from receiving specification violations from the FDA, such as:
• Failure to establish specifications for identity of product components and ingredients.
• Failure to establish specifications for identity, strength, purity, composition and limits on types of contamination that may adulterate the finished products.
• Failure to establish specifications for packaging and labeling according to purchase order and perform visual inspection of incoming products.
Having good specifications sets good expectations, a road map for success. It’s not only required by the FDA, it also helps prevent mistakes and miscommunication with the manufacturer and supply chain.