Manufacturing Drugs and Cosmetics On Shared Equipment
When : Tuesday, October 12, 2021
Time : 02 : 00 PM EST
Duration : 60 Minutes
John is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. John retired from the FDA’s Office of Cosmetics and Colors in June 2019 where he served as an SME in the areas of personal care product microbiology and manufacturing (GMP’s). Prior to FDA John served in a global capacity with Estee Lauder Companies responsible for regulatory compliance in all manufacturing facilities. In 1982 John took over the helm of Food and Drug Standards Manager for the State of Wyoming Department of Agriculture, where he became an internationally recognized leader in the adaptation of HACCP principles to regulatory programs. John was promoted to Deputy Commissioner of Agriculture prior to leaving for Este Lauder.
John Grew up on a farm in Ohio where he
learned a great deal about self-reliance, resilience, and creativity.
Leaving the farm to start his journey, John graduated from Ohio
State University and the University of Wyoming. The skills that John
learned in those early years bring him to you today. If you have a
chance, ask John about his experience as a shepherd in Wyoming’s Big
Horn Mountains. John is also a musician and vocalist, something he has
enjoyed since performing professionally at age 16.
It is common for personal care product manufacturers to dismiss the importance of applying strong GMP’s to cosmetic product manufacturing. Even the best-run firms are prone to FDA oversite due to shortcomings in their operations. On the scale of FDA regulatory responsibilities, cosmetics are as low as you can go. So why worry? It is easy to forget that all of the regulatory powers given to the FDA under the FD&C Act also apply to cosmetics. Did you know that a failure of one cosmetic product could result in compliance action against any and all products manufactured in your facility? That includes OTC drug products that otherwise meet all applicable 21 CFR part 210 and 211 requirements. Manufacturing cosmetic products in your drug product facility can lead to adulteration of your drug product and vice versa. If you handle cosmetics any differently from a GMP standpoint you need to consider how can these two classes of personal care products get tangled together? When they visit your registered drug establishment, they will take note of the cosmetics that you manufacture and look for any possible overlap that may indicate the possibility of cross-contamination. Even using the same pumps and hoses will put your products in the same boat. For example, if you follow validated procedures for processing drugs and cleaning equipment, the validation will not guarantee you are not cross-contaminating drug ingredients with cosmetics or keeping contaminated cosmetics out of your drugs. If you use the same equipment to manufacture drugs and cosmetics it is also necessary to validate that you can remove cosmetic residues the same as you would do for drugs. FDA may not notice the issue until you have a micro issue with a cosmetic product that was filed on a drug line. In this case, you may be asked to recall all drug products filled after the positive cosmetic until a passing test for the cosmetic product is verified.
It is not necessary to manufacture on the same equipment to have a problem. If your processed water test results indicate the presence of a potential pathogen and that pathogen is found in a cosmetic product, all of the drug product manufactured on the shared equipment is adulterated, even if you did not find the pathogen on your lab tests. Test results can come from FDA or your customers’ sampling. When products leave your control they are still targets for contaminant testing. Also, consider that the micro requirement for cosmetics is far more stringent than drugs!
To avoid this potential pitfall, apply the GMP STDs for drugs to all of the cosmetics you manufacture. Do not assume FDA does not care! The discussions in Congress regarding proposed cosmetic regulations have put pressure on FDA to step up audits of cosmetic firms in recent years. If you manufacture cosmetics and drugs there is an increased chance you will see FDA. Get ahead of the curve! Attend this webinar and avoid being one of the casualties!
- Regulatory powers are given to FDA under the FD&C Act
- What are cosmetics?
- GMP requirements for drugs vs. cosmetics
- What is adulteration?
- What constitutes cross-contamination?
- Validation. Why is it necessary?
- What does FDA look for?
- The true cost of a recall
- Integrating drug and cosmetics in the same facility
- Shared ingredient contamination
- Water systems
- What pathogens are important?
- Who else tests my product?
- BAM 23 vs USP testing. What is better?
- Applying drug GMP,s to cosmetics
- FDA is watching
- Potential changes to cosmetic laws and regulations
Course Level - Intermediate & Advanced
Who Should Attend
Senior management, manufacturing, R&D, lab and QA directors, managers, and supervisors.
Why Should You Attend
If your business involves manufacturing cosmetic products and drug products in the same facility you are at risk of being required to recall products due to inadequate separation and/or supporting documentation. Without adequate separation, cosmetics can adulterate drugs and drugs can adulterate cosmetics. FDA does not have to prove that adulteration occurred in order to put pressure on you to conduct a recall. If you do not adequately separate cosmetics and drugs you are open to many scenarios that can put you in jeopardy. Are your current GMP’s adequate to assure that adulteration potential is minimized? If you do not know, the answer is probably no. GMP’s alone are not capable of avoiding cross-contamination resulting in adulteration charges. Sampling and testing records can also lead to regulatory actions other than recall. If potential problems introduce unacceptable risk, FDA is likely to issue a 483, which will require you to take action within 15 days to correct problems. Are you ready to put all of your planned activities on hold while you address FDA’s concerns? To avoid this situation, you should make every effort to implement GMP’s and testing regimens to avoid problems before they happen. Is your quality system robust enough to keep you out of trouble? It is your responsibility to maintain your operations under control at all times. Failure to do so will have bad repercussions when FDA scrutinizes you.
that manufacture both drugs and cosmetics in the same facilities have
had to recall products because they did not adequately separate cosmetic
manufacturing activities from drug manufacturing activities.