If your sunscreen, face lotion, foundation, or cosmetic label includes a Sun Protection Factor (SPF) claim, they are categorized as OTC drug products in the USA. This includes typical sunscreen formulations as well as foundations and other cosmetics.
As a result of the FDA regulations, manufacturers need to ensure compliance with Good Manufacturing Practices (GMPs) under 21 CFR 211 in several areas, including:
- Change Control
- Out of Specifications
- Process Validation and Ongoing Monitoring
- Cleaning Validation
- Analytical Method Validation
- Supplier Qualification
Many companies that historically manufacture cosmetic products are not equipped to comply with GMP 21 CFR 211 Standards. FDA has stepped up enforcement of OTC drug products, including sunscreens and cosmetics. Here is a link to the latest WARNING LETTER announced for a CMO of OTC drug products. Validant advises and consults clients on how to prepare for such inspections and enforcement activity.
Interested? What’s next? Well, we’re glad you asked! Continue below –
The Next Challenge will be the 2019 FDA Sunscreen Monograph – CLICK HERE FOR LINK to the proposed Monograph. The 2014 Sunscreen Innovation Act mandates that the FDA publish a final sunscreen monograph by November 26, 2019, and the Agency indicates it is on track to meet that deadline. Importantly, FDA concludes that the 16 active ingredients originally designated as GRASE under the monograph FDA finalized in 1999 but stayed in 2002, are now categorized as follows:
- Only zinc oxide and titanium dioxide are now GRASE.
- The Agency proposes PABA and trolamine salicylate – are not GRASE due to safety issues.
- For the remaining 12 ingredients, FDA finds that there is insufficient safety data to make a positive GRASE determination at this time. For these ingredients, FDA seeks additional evidence from clinical and non-clinical safety trials, as well as post-market safety data. The deadline for submitting evidence was September 3, 2019.
This new monograph will drive significant reformulation and process validation activities from a GMP perspective. CLICK HERE for a recent presentation made by the FDA concerning the upcoming monograph.
A European cosmetic manufacturer who received an FDA Warning Letter concerning its sunscreen products reached out to Validant for assistance. Sunscreen products represents less than 2% of this client’s factory throughput. So it was clear that installing GMP standards for all their consumer products would not be economical.
Validant deployed a team with local language skills who:
- Provided a Holistic Quality System Assessment, particularly with respect to Investigations, OOS and Complaints
- Instituted an Interim Control Plan for batches produced until transfer
- Assisted with drug product outsourcing
- Building a Quality System consistent with the new outsourcing model
Validant helped this client reach a successful outcome as exhibited by the following:
- Avoidance of large site-wide remediation/delays in timeline and higher implementation/operational costs.
- Ability to move quickly to assess contract manufacturing organizations (CMO) while minimizing resource expenditure
- Demonstrated operational control in the interim
This represents just one of the success stories demonstrating how Validant can help your company in the face of the new regulatory landscape.
Validant has a long history of helping companies effectively and successfully adapt to new regulatory environments. We can quickly assess your GMP compliance and exposure to the new monograph and work with you to develop thoughtful plans, then manage an efficient execution.
We have worked extensively in the OTC drug product market to bring sites to GMP expectations and have experts in process validation who can work with your team to drive process validation.
Please Contact Us if you’re interested in discussing how we might be able to help you. Thank you!
With Validant, I have the opportunity to work with pharmaceutical companies worldwide that are working to positively impact patient health. My skills from 37 years in industry in Quality System Implementation and Quality Remediation are directly applicable to help our clients.
John M. | Validant Managing Partner since 2016
Validant offers win-win solutions for clients and consultants, continually building and maintaining lasting relationships. Their experts in business development and recruiting ensure that subject matter expertise and skill set is matched for the client and the best consultants are placed on the project.
Janet W. | Validant Consultant since 2013
In the spring of 2015, my firm had a significant FDA audit with serious findings concerning sterility assurance and data integrity. We had utilized Validant for a previous engagement successfully. Before the audit concluded, I was already in contact with the Validant team for assistance. I was very impressed by how quickly they orchestrated data integrity audits at all of our 20+ other sites. We then turned to them for assistance with our third-party oversight of our manufacturing operation and quality control laboratories.