Last Updated on October 25, 2022 by Ithos Global Regulatory Team
Since first posting this article, we have found more brands seeking to provide their contract manufacturers with direct access to the Ithos Information Network. This allows the manufacturer to upload documentation directly, saving time while keeping information organized and easy to extract, when needed. Because the IIN only provides access to your brand’s documentation – you can feel safe asking your contract manufacturer to directly upload your documentation.
Asking the right questions up front can avoid costly delays in cosmetic contract manufacturing
Finding a reliable cosmetic developer and manufacturer is critical in getting a product to market. The COVID pandemic and related supply chain challenges have shown a strong manufacturing partner is key to avoiding costly disruptions. At Ithos, we work closely with brands and their manufacturers to ensure cosmetic compliance throughout the product life cycle. Below, our team of experts compiled five tips for finding the best cosmetics manufacturer.
1. Know the manufacturer’s compliance status (cosmetic vs. drug)
When selecting a cosmetic contract manufacturer, investigate their compliance status with both state and federal agencies. Ensuring they fully comply with the Food and Drug Association’s Good Manufacturing Practices (GMPs) is imperative to the long term quality, safety and marketability of your product. If you plan to sell cosmetics globally, be sure the manufacturer is meeting ISO 22716 standards and can provide relevant documentation. If you have a drug product, verify that the manufacturer has a current drug establishment registration in addition to a local state licensure (if applicable) and is in good standing with the corresponding state and federal agencies.
2. Verify experience and competency for your product type
Manufacturers may promote new production capabilities to attract more business. For example, a cosmetic contract manufacturer may extend their services to include drug manufacturing. A manufacturer may specialize in liquids or semisolids, but incorporate powder production in their offerings. While it may sound logical and cost-effective, additional processes typically require a significant learning curve in terms of equipment, process and compliance. Scaling up GMP’s from cosmetics to drugs is no small task in development and manufacturing. Be sure to verify specific experience for your type of product up front, to avoid production or compliance challenges down the road.
3. Understand your manufacturer’s capacity
Every brand has different needs, based on product volume. A small brand may avoid using a large manufacturer initially, because their smaller product run is too costly. Similarly, a larger brand with higher volume needs a manufacturer that can quickly scale up to meet demand. As a smaller brand with lower volume, you represent less revenue for the manufacturer. As a result, you may find once you place an order, you don’t get the attention and support you need for testing, documentation, research & development, sourcing raw materials, etc. At that point, it is too late. Do your homework by asking to speak to current customers of similar size. Be sure the manufacturer has a good track record of client service before you start working together and agree via a contract to their ownership for compliance and R&D related activities.
4. Insist on a formal manufacturing and/or quality assurance agreement
One of the biggest lessons learned during COVID is the importance of formal manufacturer agreements. While a Quality Assurance agreement is a regulatory requirement for drug products, a contract should also be in place for cosmetic production. To protect your brand, be sure agreements document all expectations of the manufacturer before you begin working together. They should also detail who is responsible for handling all compliance, operations and financial roles.
A formal outline of all required Product Information File (PIF) documentation should be established, especially when marketing to multiple countries. It speeds up diligence efforts when verifying a brand’s product and facility compliance, and helps meet international registration documentation requirements. Be sure to include the types of development testing required, as well as facility and financial responsibilities. Without agreements in place, a brand can only rely on expectations set for a particular purchase order only – and may suffer unintended and disruptive consequences in payment, production time, ingredient sourcing and other compliance issues.
5. Gauge your manufacturer’s responsiveness
Vendors come and go, but true partnerships endure – and are key to maintaining your supply chain. By testing how responsive your contract manufacturer is early in your relationship, you can avoid frustration in the future. Expect accurate, timely responses. If you’re not hearing back quickly, start looking for alternatives. Talk to other customers. Due diligence early on can avoid costly setbacks. Locking in a true partner ensures your contract manufacturer is ready to grow with you, as your product portfolio and target markets expand.
US FDA Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics
International ISO 22716:2007 Standard
Current Good Manufacturing Practice—Guidance for Human Drug Compounding OutsourcingFacilities Under Section 503B of the FD&C Act Guidance for Industry
Voluntary Cosmetic Registration Program
Drug Establishments Current Registration Site
FDA OTC Registration and Listing
Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry
Whether you’re a brand, manufacturer, retailer, or raw materials supplier, Ithos can help ensure safe, quality, compliant products. We help speed up approvals and alert you to new regulations – all while keeping your documentation and product history organized and accessible.