Demonstrating compliance in cosmetics and personal care product manufacturing is a complex process due to the intricacies of its regulations. The Food and Drug Administration (FDA) is the main body that oversees the sale of all cosmetic products in the US, but according to the agency’s own language, it does not grant approval for items before they enter the market. They do, however, have several stringent rules for what ingredients can be used in and even what constitutes a cosmetic product legally. Noncompliance can bring a number of penalties for cosmetic manufacturers, including warning letters from the FDA, fines and even seizure of goods.
The ability to extract accurate product data from processing and distribution procedures in integral to cosmetic manufacturers maintaining compliance. Integral to cosmetic manufacturers maintaining compliance is the ability to extract accurate product data from their processing and distribution procedures. This requires a comprehensive business management solution that provides consistent insight into production and supply chain operations and functionality that can incorporate multiple regulatory standards. SWK’s Sage X3 for Cosmetics bundled solution delivers precise product traceability and reliable reporting to allow cosmetic manufacturers to meet compliance with FDA regulations.
Here are a few ways SWK’s Sage X3 for Cosmetics Compliance Software bundle can deliver value to cosmetic manufacturers seeking to ensure compliance:
Many of the regulations that directly affect the viability of cosmetic and personal products primarily address the materials used in their production. The FDA has several guidelines that determine the compliancy or even the definition of an item as a cosmetic based on the ingredients included. There are also protocols which establish processing and handling standards for the management of raw materials at multiple stages of cosmetic manufacturing.
Ingredients such as color additives bring their own set of regulations governing their introduction into cosmetic and personal care products. The FDA only allows a particular list of additives to be used within specific guidelines, and failure to meet these results in a product being labeled adulterated, which effectively means it is deemed unsafe. Certain certified colors also have uncertified versions that can be easily confused with the correct variety yet substituting these in place of their counterpart breaks compliance with additive regulations.
Sage X3 for Cosmetics monitors and records all raw material movement from procurement to processing and manages quality control throughout. Utilizing ERP process manufacturing functionality, it tests material status against specifications programmed into the system and tracks results from production. The Sage X3 for Cosmetics bundle allows you to ensure contaminated raw ingredients do not enter end-product mixtures and noncompliant materials are removed from processing batches.
Cosmetic products sold in the US must comply with the obligations put forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FP&L Act). Items including a list of all ingredients, quantity of contents, and a descriptive name or illustration must be displayed clearly on the product or must accompany it in some capacity. Ingredients must be placed somewhere prominent and have to be sized in proportion to the product packaging to ensure consumers can identify them easily.
Materials that may be potentially hazardous must also be listed, and though the FDA technically does not require manufacturers to test the safety of their products, those that may be unsafe can become noncompliant or be forced to feature a warning label. The FDA also reserves the right to inspect products as well as their manufacturing and storage facilities, and to seize any that might be harmful to consumers or mislabeled. The agency can even go so far as petitioning a federal court to file a restraining order against the manufacturer of the noncompliant product or pursue criminal charges.
Leveraging Sage X3 for Cosmetics for maintaining compliance with FDA regulations allows you to streamline labeling processes. SWK’s Sage X3 bundle keeps track of all materials for batch production and uses this data to produce container labels for all end-product packaging. All ingredients are recorded and listed to comply with legal obligations, and potentially hazardous materials can be displayed according to FDA guidelines.
The FD&C Act prohibits the introduction of any cosmetic (or other product falling under the jurisdiction of FDA regulations) into “interstate commerce” that may be considered adulterated or mislabeled. In a legal sense, interstate commerce effectively encompasses all stages of a cosmetic or personal care product’s production, distribution and sale as at least one component within the value chain will often originate from another location. Maintaining traceability for all products entering distribution enables cosmetic manufacturers to avoid violating this rule and ensure compliance.
The added regulations in cosmetic manufacturing that stem from product definition and classification concerns can create new requirements for supply chain visibility. Any cosmetic or personal care product whose intended use fulfills a function similar to a drug can be classified as one or as both. For example, a shampoo that is marketed for anti-dandruff purposes would be considered both a cosmetic and a drug and would therefore be subject to the Drug Supply Chain Security Act (DSCSA). The DSCSA places increased tracing requirements on the distribution of products classified as drugs, which currently includes lot tracking and serialization obligations and will escalate to unit level traceability across all supply chain processes by 2023.
The Sage X3 for Cosmetics compliance solution provides unit-level tracking capabilities that other business management software systems were not designed for. It contains native traceability functions that allow for drug identification through product serialization to comply with the DSCSA as well as verification for GMP in the event of a recall. Deploying Sage X3 for Cosmetics for product traceability will enable you to implement accurate track-and-trace procedures throughout your supply chain to locate items on-demand to maintain compliance. SWK’s own MAPADOC EDI solution is included within the bundle to streamline communicating serialized data with retail trading partners.
4. Shipping & Storage
The DSCSA and the FD&C Act both contain stipulations regarding the proper handling, transportation and storage of cosmetic end-products. The FDA also implements additional rules for the importation of cosmetic and personal care products and product materials from outside of the US. These regulations address the safety of such products and their raw ingredients for the intended use by consumers for the duration of they are sold.
An important aspect of meeting compliance in this area is identifying and maintaining the shelf life of individual products. Though the FDA does not technically mandate cosmetic and personal care products have expiration dates, it is considered best practice for manufacturers to maintain shelf life. Failing to do so can risk products being labeled adulterated. As many cosmetic products may also be considered drugs or hybrid items, these will fall under the jurisdiction of regulations regarding drug products, which do, in fact, require expiration dates to meet compliance.
SWK’s solution bundle includes shipping and warehouse management functionality in addition to quality control features. Perishability of raw materials and end-products is accounted for within the system and cross-checks of product quality notify users of stock rejected for expiration dates past due. Automated shipping and warehousing processes allow for precise control of product distribution to ensure items are delivered within their acceptable shelf lives.
The FDA incorporates several of the standards of the International Organization for Standardization (ISO) into its Current Good Manufacturing Practices (CGMP), specifically ISO 22716. Among the practices adopted are the requirements for documentation and record keeping for certain cosmetic production procedures. This is done for the purposes of establishing traceability for errors that may occur as well as allowing the ability to notify regulatory authorities.
Sage X3 for Cosmetics provides your business with electronic audit trails for all final input tasks to allow you to trace processes back to the user level. This fulfills requirements for record maintenance for 21 CFR Part 11 and GMP which mandate documentation of all production steps taken. In the event of a recall or another incident, archives can be produced to demonstrate compliance initiatives.
The Sage X3 Cosmetics Bundle Provides Cosmetic Manufacturers with the Tools to Ensure Compliance
SWK’s Sage X3 for Cosmetics bundle enables cosmetic manufacturers to fulfill compliance objectives for the FDA, Canada Health, and any other domestic regulatory agency overseeing production and distribution for process manufacturing business.