Bruce Albert- Chief Science Officer, CC Wellness
CC Wellness is a small company in the heart of the Santa Clarita Valley in southern California. The company manufactures personal lubricants, over-the-counter (OTC) drug products, and cosmetics, and has fully embraced a world-class quality management system (QMS). Who would have guessed this tiny company would become a global leader in "extreme quality manufacturing" of intimate wellness products?
Savvy Consumers Drive Extreme Quality
So, what is extreme quality manufacturing and why is it so important? It’s the latest buzzword characterizing consumer demand for high-quality intimate wellness products. Consumers have become quite savvy. After all, personal lubricants go in and not just on the body. It’s only natural that consumers would demand intimate wellness brands deliver products that meet the standards of extreme quality.
Many of the personal lubricants sold across this competitive intimate wellness market have been developed and manufactured by CC Wellness. This is thanks to its booming white label business in which the company sells its formulations to other brands, including those of many CPG multinationals.
Just producing quality products is not enough in today’s world. Filling a bottle to the right level, putting a label on straight, and making sure the bottle is sealed properly would give the outward appearance of a quality product. But is it? Extreme quality requires much more attention to detail. Extreme quality means ensuring the packaging meets rigid specifications and that it isn’t made using chemicals that might react with the product in an unintended way. Extreme quality means ensuring all raw materials meet United States Pharmacopeia (USP) requirements and do not contain harmful trace compounds. Extreme quality means accurate inventory, validated cleaning processes to ensure product safety, and so much more.
Excellence in Quality Management Makes All the Difference
Quality assurance is key in a sector that is so dependent on FDA premarket notification (PMN). Being fluent in the PMN process for intimate wellness requires a well-developed and sophisticated quality management system (QMS). Establishing the kind of quality management system required for extreme quality manufacturing started for CC Wellness when the company became ISO 13485 certified.
Extreme quality manufacturing must be continually audited to ensure compliance with the most demanding standards. This process begins with ISO certification. There must be a level of commitment, as well as FDA regulatory compliance, before a company may apply for ISO certification.
Defining ISO Certification
More specifically, what is ISO 13485 certification?
ISO 13485 is a set of international standards governing the manufacture of medical devices. Yes, personal lubricants are Class II medical devices. CC Wellness has been ISO 13485 certified since 2015. To ensure compliance, the company is audited annually, a process in which every aspect of the QMS is tested and challenged, from receiving to shipping and everything in between. Every third year the company has to go through a full recertification. Every system within the organization must follow a set of written SOPs (standard operating procedures), rules that are detailed in ISO regulations.
In addition, and where applicable, the individual tasks within the defined system must be carried out following a written set of instructions. The performance of the system must be tracked by setting expectations and matching those expectations against performance, i.e., the key performance indicators (KPIs). If the system fails to meet its KPI goals, a corrective action plan is created and monitored to ensure performance goals are achieved.
Quality Checking Your Vendors
The QMS requires that every vendor — for raw materials, components, labels, or the clinical and analytical laboratories that conduct the company’s safety testing — must carry their own certifications and be qualified by CC Wellness before the company may purchase their goods or services. A few years ago, the company began an initiative to purchase raw materials and components only from suppliers within the U.S. or European Union. Overseas quality checks coming from Southeast Asia and China have turned out not to be rigorous enough to meet the company’s quality standards. All too often, components or raw materials had to be rejected because they didn’t meet the standards of extreme quality. In an environment in which users are demanding extreme quality, it makes no sense to cut corners.
What Does Extreme Quality Mean for White Label Customers?
Multinationals and independents need a partner they can rely on for the manufacture of their white-label lubricants. In fact, a good deal of what’s online or on the shelf are CC Wellness formulations. Few intimate wellness manufacturers go to the extreme of monitoring all ingredients and components for every batch manufactured, but CC Wellness thinks this is a must. Every raw material and every component is intensely scrutinized in-house at every step and for every batch in the manufacturing process. Validating every raw material means running materials through rigorous microbial evaluation using the company’s state-of-the-art rapid micro-test equipment.
Purity Evaluation Using Infrared Spectroscopy
Every material is also evaluated for purity using infrared spectroscopy. This provides a proven early warning check to flag any quality issues. Each set of process instructions for every product is validated before the product is placed on the market. This same process is validated each time a product batch is made. The bulk product is measured against the specifications established when the process was initially validated. This ensures that the product released to the market remains the same as the product originally placed on the market. Retained samples of every product made are kept for seven years. The CC Wellness focus on extreme quality has resulted in a precision manufacturing process for intimate wellness products. This is exactly what buyers should look for when selecting an extreme-quality white label manufacturing partner.
QMS Is Path for Formulations Success
The CC Wellness portfolio of intellectual property is second to none in the white-label sector. In fact, it would take years for other manufacturers to catch up to the FDA 510(k)-certified formulations created by CC Wellness. Having a well-tuned and robust QMS is key in selecting a white-label manufacturing partner. Operating in a sector dependent on the PMN process makes it all the more crucial to select a partner that understands the rules and regulations of Class II medical device product registration.
What this means to a potential white label customer is lightning speed to market. CC Wellness is expert in the FDA PMN process for certifying its intimate wellness products. The company holds 24 personal lubricant FDA 510(k) premarket certifications. This is the most of any white label manufacturer and second only to CPG giant Reckitt (the maker of KY and Durex brands).
Other Factors in Selecting an Intimate Wellness Manufacturer
Other important features white-label customers should look for when selecting an intimate wellness manufacturer include the extent to which they have experienced product recalls. Product recalls are a red flag. Recalls are a clear indicator that a company's QMS isn’t working. Recalls can happen for many reasons — e.g., wrong bulk in the bottle, wrong label on the package, foreign material in the bottle, wrong spelling on the label, and so on. But at the end of the day, it adds up to a failure of the quality system. And if there is one failure that results in a recall, there are likely many other failures that were not caught. This is why intimate wellness manufacturers need to embrace extreme quality. CC Wellness has fine-tuned its QMS such that it not only has never had a recall, but also has a nearly zero product complaint rate.
Continuous Improvement Program
Another thing that sets the company apart from other wellness product manufacturers is a well-established continuous improvement program. Continuous improvement is an integral part of the ISO 13485 process. It is also the cornerstone of extreme-quality manufacturing. This is why bringing continuous improvement in-house is so critical to any company’s extreme quality initiative. It is also why CC Wellness is expanding its laboratories from 3,000 sq. ft. to more than 20,000 sq. ft. within a new 215,000 sq. ft. manufacturing facility.
To meet increasing demand, CC Wellness recently acquired additional capacity in the form of a new mixing vessel. This vessel, or mixing tank, is equipped with a high-speed mixer. The tank increases manufacturing capacity by 6,000 kilograms per day. The vessel is currently undergoing process validation to ensure that any products made in it in the future will match the established specification for those products.
The migration of the CC Wellness manufacturing process to its FDA licensed and ISO-certified facility enables the company to better monitor every aspect of its QMS. Bringing it all together under one roof not only makes the company the largest white label “Made in USA” manufacturer in the intimate wellness industry but drives home its preeminence in extreme quality.
Bruce Albert is Chief Science Officer of CC Wellness, a Santa Clarita, Calif.-based pharmaceutical company that offers premium turnkey white label formulation development for established and independent brands across Amazon, specialty retail, and mass retail channels. He has more than 35 years of R&D leadership in cosmetics, OTC, and Class II medical devices at well-known companies like Merle Norman Cosmetics, OPI, and Markwin International.
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