Good Manufacturing Practices for Cosmetics - A new Revelation?

The basic concepts of Good Manufacturing Practices (GMPs) and other issues related to product quality assurance for both OTC and Cosmetic products truly have not changed since GMPs were introduced in the 1960s. What has changed is the regulatory environment and the acceptance of doing business on a global stage. With the enactment of the Modernization of Cosmetics Reform Act of 2022 (MoCRA), the FDA has been, by law, instructed to formerly address the implementation of GMPs as applied to the manufacture of cosmetic products. Frankly, the US has been behind the rest of the world for over a decade in adopting a product regulatory framework to enhance and monitor cosmetic product safety. One may argue, and rightfully so, that the US cosmetic industry, as a whole, has done a wonderful job in protecting its consumer base. I would like to think the Society of Cosmetic Chemists has had a meaningful role in this success.

I shared a vision on GMPs with the IMWSCC in February 2016. At that time, the GMPs in the European and Asian markets had been essentially enacted. In 2013 the FDA published a guidance on GMPs for cosmetics which adopted most of the ISO 22716 requirements, the standard being utilized by the rest of the world.

In December of 2025, the US cosmetic industry will be required to comply with GMP regulations, the specifics of which will most probably not be made public until later this year. That being expected, there are many basic concepts and areas of GMPs that one should have now in place either as a component of good business practices or to ensure a quality and safe product is offered to consumers by them.

The FDA today is driven by quality management principles. GMPs are a significant part of that philosophy. Companies are expected to have committed in writing their vision of a Quality Management System (QMS). Preparation of Quality Manual is the first step. To put this in perspective, the topics in a QMS are a large part of what are encompassed in the GMPs. To document your quality practices, standard operating procedures will need to be prepared, formerly adopted, and most importantly followed to be compliant with the regulations.

As an introduction to good manufacturing practices, the areas which should be addressed in your quality management manual, and for which an inspector may wish to see SOPs affecting, are presented in Table 1.

Table 1

Quality Management System Contents

 Personnel

 Internal Audit

Premises

Storage

Equipment

 Contract Manufacturing & Analysis

Sanitation & Hygiene 

Production Product Complaint

Quality Control

Product Recall

To outline some of the general provisions, here are some details to consider:

1. Personnel: Employees (including management) must all have GMP training. In addition, annual training in GMPs is a requirement.
2. Premises: The facilities must be maintained and kept clean. The water used in cosmetics should be prepared and monitored to be safe and suitable for use in cosmetics.
3. Quality Control: Procedures should be in place to confirm the raw materials used in the manufacture, and the finished product produced therefrom, are safe for the consumer following the product label instructions and warnings. QC personnel must also possess the necessary skills, either through education or experience, to do their jobs.
4. Controls of Components, Production, Warehousing, and Shipping: Each of these functions are shared responsibilities as these functions transcend many of the daily operations in cosmetic product manufacturing. Documentation is the heart and soul of these functions, because, in the eyes of the FDA:

Rule #1 If it isn’t written down, it didn’t happen.

Rule #2 If it isn’t written down properly, you’re not sure exactly what happened.

Rule #3 If the records aren’t correct, neither is the product.

Adverse Events and Recalls: FDA can now mandate, and if necessary direct, the recall a cosmetic from the marketplace. Adverse events, as defined in the law, must be reported to the FDA within 15 days of their discovery. Companies must have procedures in place to manage communications of adverse events, to investigate the reported event, and to complete and report their findings to the FDA. Furthermore, procedures should be in place to recall a cosmetic from the market following the FDA recall guidelines for cosmetics. An important fact to remember is any documentation generated during the handling of an adverse event may become evidence should litigation arise.

Proper documentation enables one to prove cosmetic products are safe, pure, and effective. It should be easy to understand compliance to GMPs is definitely documentation driven.

Failure to be GMP compliant will result in your product being found "adulterated" per MoCRA. Once that happens, a whole cascade of activities will most probably occur. For sure, you will receive a communication from the FDA, either in the mail, in person, or both. The action of the agency will depend on the severity of the findings. Exactly how the FDA will manage noncompliance is unclear and will become more evident over time.

Creating a GMP friendly environment takes time, consumes resources, and most importantly, a commitment of management and employees to do what is needed and what is right. Change may start at the top, but success must be owned by the entire organization!

Meet the Author

Karl Popp founded KPopp Consulting, LLC in 2010 as a consulting firm providing services to pharmaceutical, cosmetic and allied industries. He also is a licensed pharmacist. Karl has been advising cosmetic, nutritional, and pharmaceutical companies on opportunities and constraints for many years. From 1989 to 2008 he was associated with Stiefel Laboratories as Director of Product Development, and later as Senior Director of Special Projects coordinating external manufacturing, global research activities, and managing the corporation’s intellectual property estate.

Prior to joining Stiefel in 1989, he was a Scientist and Project Manager for the Sterling-Winthrop Research Group. During his career he has been responsible for the development of products that have generated over $2 billion in sales. He has directed the successful development and/or government (FDA) registration of over 50 new OTC, IND/NDA, and ANDA (generic) drug products as well as numerous cosmetics products. Karl also is Vice President of Pharmapotheca A, LLC, a company focused on developing and commercializing pharmaceutical technologies for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) in adults and children. He also serves as a consultant for the pharmaceutical, cosmetic, and allied industries. He earned his B. S. in Pharmacy from the Albany College of Pharmacy, an M.B.A. from Rensselaer Polytechnic Institute and is licensed to practice pharmacy in NY.

Karl is a past President of the U.S. Society of Cosmetic Chemists (1999) and elected a fellow to the Society in 2002. He has been active in the SCC in coordinating local educational seminars, served on the National Committee on Scientific Affairs and as the Society’s President in 1999 and was a past Chair of the New England Chapter. Karl was elected a Fellow of the Society in 2002 and Emeritus Member in 2015. Recently, he presented a review of cGMPs for Cosmetics for the SCC National. He is an inventor, an author and a scientist.

Along with over 30 patents, he has also authored/co authored numerous technical articles and book chapters. His interests encompass topical, oral, inhalation, and drug delivery dosage forms in addition to various therapeutic categories. During his over 50 years in the industry, Karl Popp has lectured around the globe on new product development activities including GMPs, regulatory strategies, product pipeline efforts, process validation, product life cycle management, and management of intellectual property.

Karl has been active in his local American Cancer Society chapter, its ostomy support group, and a Survivor to Survivor Counselor for the Bladder Cancer Awareness Network (BCAN). Karl Popp reports he has no financials relationship with the FDA or other providers of MoCRA related services. The opinions presented are those of the author and are presented for educational purposes.