By Craig R. Weiss
Testing for product safety and claim support is crucial in the highly competitive, possibly soon-to-be-regulated personal care market.
If you are just getting started, or need a refresher course, seek guidance from experts. These days, finding information is simple. Search Google for “cosmetic claim support” and find 2 million entries on the subject and even more if you search “cosmetic safety testing.” Don’t forget important industry groups including PCPC, Cosmetic Europe, ICMAD and ASTM.
There are also governmental regulatory guidance documents. There is so much out there, how do you know where to go and what will protect your company?
One important source of information is contract test laboratories. Recent history has shown that you need to be an educated consumer when it comes to testing organisations to keep yourself and your company out of trouble.
So, how do you evaluate a testing facility? How do you know which lab fits your needs? There are many important criteria that should go into your decision-making process.
Price, certainly an important criterion, but should it be the most important? While the bottom line is important, there is truth to the adage “you get what you pay for.”
There is nothing more expensive than a study that fails to meet its objective or gives you inconsistent or false data. That is not to suggest that the most expensive option is always the best, but should a laboratory’s price be significantly less than all other bids, there must be a reason why.
Remember to compare apples to apples, as there are many ways to test for the desired end-point, some are better than others for your product.
Not all possible methods are appropriate for your purposes or product. What do you do if you talk to two different labs and they tell you two very different things?
Seek the opinion of a third lab and then compare. If that doesn’t work, there are other sources, regulatory attorneys, consultants and your trade associations may be able to help you.
In today’s world of short production cycles, a laboratory’s ability to meet a reasonable time frame could be a deciding factor.
Timing is not just turn-around time for your testing, but how long it takes to establish a testing protocol, conduct the study, perform quality assurance review and issue the final report. Is the laboratory willing to accommodate you when you’re under the gun by offering you interim reports or top-line results?
As a recommendation, the earlier you bring a laboratory into your planning, the less likely it is that there will be problems meeting your deadline. For example, for a simple moisturisation test, it could take up to two weeks to recruit the test panel; recruiting for complex studies could take three or more weeks. Understand your laboratory doesn’t own a time machine and a four-week clinical trial can’t be conducted in three.
Another often overlooked criterion is confidentiality. While confidentiality should be a given, understand that a confidentiality agreement should be more than a piece of paper.
When touring a laboratory, you should not see a competitor’s products or data lying around. In fact, what you should expect to see (with few exceptions) should be coded, unidentifiable products being tested.
When asked about its clientele, a laboratory representative should politely explain that this is confidential information. While it is nice to know that the laboratory you selected is working for large, multinational companies, it is unethical for the lab to release confidential information. If they let you know who they are working for, they are also more than likely releasing your information, as well.
Innovation should be considered when choosing a site to test your product.
Many times a testing lab comes face-to-face with something so new there is no industry standard for conducting a study. A laboratory should be able to develop a scientifically based and defendable method for the claim or product.
This is not always possible, especially if the product is in a regulated or monograph drug category, but there are many stories of tests that had to be developed for features and claims that didn’t exist when a product was developed.
The ethics of anyone who you do business with is important, but it is essential in a testing facility. When visiting or auditing (which I highly recommend) your laboratory, you should be allowed complete access to your study.
This includes the ability to view the biophase of your study to be sure your study is being conducted in compliance with the protocol you approved. It should make little or no difference to your lab if you decide to audit your study unannounced (without making an appointment.)
In addition, you are entitled to see all your study’s documentation including raw data, although certain demographic data may be withheld for compliance with regulatory guidelines. You should also be able to get copies of the raw data, but be aware you may be charged for that service.
Moreover, you should ask to see training records of the personnel that is running your study, calibration records, standard operating procedures (SOPs) and all validations of test methods.
Once you have begun to audit your study and testing facility, what should you be looking for? Compliance.
This is important not only to the testing procedure but to all appropriate regulations and SOPs. Given that any study may become part of litigation, especially in less-regulated product categories, it is extremely important that the laboratory has been audited by you, and/or a regulatory agency, and has been found in substantial compliance.
In this global economy, the laboratory should be conversant with worldwide regulations and methods.
Quality, once again, is important. This should be a given, but “quality” is more than the signature of a quality assurance officer on a report or a signed quality agreement. Quality refers to the organisation of the laboratory.
Does the laboratory have enough personnel to conduct the number of studies it normally conducts?
Does the laboratory have an independent quality assurance department that answers to the president or chief executive of the company, not to an operational department?
The laboratory you choose should know the industries they serve and should be able to advise you as to what the industry or regulatory standard is for the testing you require.
Keep in mind that every lab has its limitations and should be able to tell you what those are up front. Additionally, they should know and tell you when something is impossible or may change the regulatory category of your product.
Without the ability to communicate with your laboratory when you need to, many of the points I laboured to bring to your attention are rendered moot. You should be able to call and discuss your projects either ongoing or future, without feeling like you are imposing.
You should not feel as if you have just sent your product into a black hole for testing. Equally important, if something is going wrong with your study halfway through, the testing lab should tell you about it immediately, not after the study has finished or when the final report arrives.
In my humble opinion, the most important criteria in choosing a laboratory to test your product are industry standard methodologies and equipment.
It is in your best interest to use a laboratory that is up-to-date with both methods and equipment, as they can conduct studies that are scientifically defensible.
Certain methodologies work better for certain products and claims. This is not to say, if your laboratory is using a new piece of equipment, or method, even one they developed in-house, it isn’t appropriate.
It likely is if there is scientific validation proving the results are accurate. Many scientific and regulatory organisations suggest running competitive methodologies to test your product to cover all your bases, but most companies want to pay for only one – the best one for its product.CRAIG R. WEISS IS PRESIDENT OF CONSUMER PRODUCT TESTING COMPANY