OPINION
and add some of the older, less expensive chemistries in order to obtain synergistic effect that will provide the best of both worlds.
When a supplier comes up with a new technology for my evaluation, the expectation is that some work has been done in terms of the product efficacy, safety, toxicology, manufacturing logistics and supply chain. All these elements, however, are frequently established based on some internal, unique to the supplier guidelines and that may be completely irrelevant to how our company evaluates such raw materials. While toxicology, microbiology or clinical safety and analytical often follow the same industry standards, the resulting data may in fact differ from what would be obtained internally. The difference may be in the size of the sample; for example, most suppliers would run an HRIPT study on a maximum of 50 people that may not reveal the same results as a test run with 100 subjects. Another contributing factor would be the type of prototype formulas used for screening. Any incompatibilities would have to be assessed as well as any synergistic effects may, in fact, magnify the material’s capabilities beyond its true effect. For instance, presence of glycols may enhance the active’s penetration, whereas surfactants may provide another layer of complexity and improve antimicrobial efficacy.
Therefore it is important to really do your own homework, as in evaluate the material according to your own requirements with special attention paid to safety, efficacy and quality of the material. It is impossible to stress enough the need to evaluate all incoming materials analytically, as there have been cases in our industry of products which do not specify in their CoA presence of certain ‘residual’ compounds, such as formaldehyde, benzene or salicylates – which, in the last example, can easily convert into a salicylic acid if your final product pH is below 5, and that would make it illegal to be marketed in Europe for baby products (CFR).1
Another red flag is any sort of exclusion of well-established methodologies on the manufacturer’s CoA. There have been instances when a particular analytical methodology was clearly exempted from the supplier’s list due to the apparent ‘false-positive’ reactions that would indicate any unwanted pollutants in the raw material. And while, scientifically speaking, such a possibility for interference exists; it surely should be investigated as a potential risk factor.
So how can one ensure that all the angles are covered and nothing falls through the cracks?
22 PERSONAL CARE April 2012
Qualifying the supplier As the new raw materials enter your company’s system, there are several important steps required for full qualification, which will likely differ from company to company. However, I would imagine that in order to protect the hard earned reputation and to ensure best fit with current selection of materials some variation on the following is performed: The first assessment should always evaluate the supplier’s efficacy claims; after all, if you cannot reproduce the antimicrobial efficacy of a new preservative in your formulas, there is no need to follow up with any additional work. Once you have established that the new material is comparable or superior to what you already have in your arsenal of ingredients, the next step would be to review and reassess its toxicity and clinical safety. As mentioned previously, sometimes the supplier’s data may be insufficient, but often, even with the most robust dataset, the risk is not recognised until a product with the new active lands on the market and is used by a significant number from a highly diverse population. That is why due diligence is so important and familiarity with internal formulas, the types of products being marketed and the population being served can only come from an internal expert. While all the technical reviews and the qualification work are being conducted, and at this stage any laboratory work performed should be conducted on more than just a single lot, there also should be an effort to assess the supplier’s overall quality systems and financial health. Supply chain management is one of the toughest aspects and when a supplier goes under your products are at risk of disappearing from the market for the lack of key ingredients. Any supplier should be able to demonstrate that their financial stability is ensured and that, however the ingredient is manufactured, the manufacturing processes, distribution and delivery steps are not vulnerable to any disruptions. It does not matter if a new raw material promises to revolutionise the industry if it cannot be obtained. A non- existing product cannot be sold and will not bring any profits, but can surely hurt a company’s reputation.
Quality and consistency are equally important and so involvement of the Quality unit and ensuring that manufacturing processes reflect the regional and international standards (such as cGMP, ISO, etc.) are met is crucial. Sometimes, this may mean a trip to the far reaches of the globe to audit a plant in a foreign country that may reveal a serious risk or reassure that a quality product will be consistently delivered. Any refusal to audit should be seen as a potential risk to quality and
robustness of the supply chain. After all, an audit can be scheduled with proper confidentiality agreements in place or even executed by a third party that would alleviate any concerns or difficulties that so often surface when building completely new relationships. And so, finally, the new ingredient is available to your company and you can be sure that it will be available with consistent quantity and quality. But the work is not over. Our field is very dynamic and ever-changing, thus, the steps taken at the beginning that helped build personal relationships will now be more crucial than ever. After the delivery comes the time where some technical problems may arise; a new formula does not behave quite the same way as the previous products, maybe there is a problem with batching or maybe there is an unexpected negative PR campaign. Will your supplier stand by you and provide proper support? Is the supplier even capable of expending its R&D resources or spending money on professional communication to address the unforeseen consequences that suddenly become apparent, after the new launch? Regardless of the size of your business with the supplier, certain expectations, at least specific to the sourced materials, should be in place. It is clear that global markets are extremely competitive and commodity suppliers abound, fighting for the market share. When prices are cut aggressively by the worldwide competition, you do not want to be caught partnering with the cheapest supplier, just to discover that with the low cost, comes much higher price of doing business due to lack of support, exposure to high risk operations and complete inattention and laxity to your needs.
Conclusion In summary, nothing will ever substitute the power and capability that come from professional relationships built on solid, honest and mutually beneficial agreements. The proverbial gentlemen’s handshake is probably not enough in today’s complex legal environment, however, the negotiations, agreements and legal structures should only help to strengthen bonds and gain better focus when doing business. The ultimate outcome will always be proven by the industry leaders who take innovation to the next level and are able to influence the consumers and shape the marketplace, by partnering with trusted suppliers capable of customising their R&D efforts to deliver the next big hit.
PC
Reference 1 EU Directive 2007/17/EC Annex VI, Part 1; List of preservatives allowed.
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