As communities around the world are adapting to the continued threat of Covid-19, demand for alcohol hand sanitizers is heightened and looks to remain that way for the foreseeable future. Shortages of hand sanitizers and their raw materials have led regulatory authorities around the world to implement emergency measures and templatize alcohol-based formulas to increase hand sanitizer production in a harmonized, effective, and safe manner.
This presented a new opportunity for the personal care and cosmetics industry to respond to the Covid-19 crisis. Cosmetic companies like LVMH’s DIOR and Estée Lauder have converted parts of their production lines to produce hand sanitizer, and now use a wide choice of gelling agents and humectants, as well as several categories of alcohol.
We sat down with Veeva’s resident regulatory management expert Ariane Divetain to understand the measures that were and are still being undertaken jointly by national authorities and cosmetics manufacturers to rapidly bring hand sanitizers to market.
Veeva Industries (VI): Thank you for joining us Ariane. To begin, how was it possible to mobilize entire perfume factories to produce tons of bottles of hand sanitizers per week?
Ariane Divetain (AD): Thank you for having me. To address your question, regulatory authorities have established accelerated and transitional national procedures in response to the urgent need for hand sanitizers. Let’s review some of the latest changes by region and country.
In Europe, each Member State is implementing measures to facilitate hand sanitizer production. ECHA has set up a portal in order to provide visibility at the European level. For example, by way of derogation, France made temporary legislative changes to authorize the use of specific hydroalcoholic biocidal disinfectants in an Order published 6 March 2020. The Order temporarily authorizes specific hydroalcoholic products for human hygiene and surface disinfection in France until 31 May 2020. In this case, companies can commercialize one of the four formulas of hand sanitizers following the indicated compositions of the French decree and with specific labelling elements, without any other regulatory process. Furthermore, the new decree of March 27th provides additional possibilities for producing hand sanitizer gels, like the authorization to use cosmetic-grade glycerin.
In the US, the FDA released a temporary guideline in March to respond to entities that are not currently licensed or registered drug manufacturers but would like to prepare alcohol-based hand sanitizers. Formula manufacturers are authorized to prepare hand sanitizers only from a specific formulation using United States Pharmacopeia (USP) grade ingredients and label their products in accordance with appendices of the guideline. However, before marketing the products, firms must register their facility and list these products in the FDA drug registration and listing system.
In Canada, the “Monograph for Antiseptic Skin Cleansers” was updated at the end of March and beginning of April, including dispositions to accelerate the authorization for the production and distribution of alcohol-based hand sanitizers (natural health products). Applications for operating and marketing licenses for alcohol-based hand sanitizers will be issued within 24 hours by Santé Canada (depending on level of requests) if all the requirements of the monograph are met. Furthermore, Cosmetics Alliance Canada has developed an exchange platform to maximize and accelerate the production of hand-sanitizers by matching the needs of manufacturing facilities with the raw materials availability.
These measures have helped the cosmetic industry, not used to deal with hand sanitizers product quality and regulatory process, to deliver these products.
VI: It seems that the regulatory authorities are showing remarkable speed and agility in response to this crisis. Can you explain how companies inexperienced in manufacturing hand sanitizers products are able to participate in the fight against Covid-19?
AD: To be able to quickly deliver compliant hand sanitizers to hospitals, clinics, mass distribution and pharmacies, it all depends on collaboration. Collaboration is required across the entire supply chain from the formulation, through the claims validation, to the manufacturing site and the delivery of compliant batches. Collaboration also has to be consistently practiced internally between different departments and externally with approved raw materials suppliers.
Some companies are successfully rising to the challenge and collaborating to quickly adapt to their new mandates. However, other companies are butting up against outdated systems that force them to make reactive decisions rather than proactive ones because their content and data management are separate enterprises governed by separate systems. It’s hard to move fast when required information is located in spreadsheets accessed by a few people, and approval of the content is done by email. Teams have no clear request channel, no formalized review, and lack of reporting leads to unnecessarily extend product development times.
This is where the success stories stand out from the rest. They utilize modern digital business solutions that unify and streamline processes, documents, and data. This enables the organization to absorb failures and continue delivering products and services within acceptable time frames even during a disruption (ISO norms related to resilience and business continuity, ISO/IEC 27031:23011, ISO 13824:2020, ISO 22301:3019).
Modern regulatory and quality management solutions include capabilities such as configurable workflows, role-based permissions, and user group creation with delegated access in a unified platform. This allows those working in regulated industries like cosmetics to effectively leverage information and transparently orchestrate compliance-related activities at manufacturing sites, supply chains, with subcontractors, suppliers and all internal stakeholders. Product information is accurate, up-to-date, and accessible throughout the product life cycle, supporting business activity even during a crisis.
VI: That’s a very helpful way to distinguish companies that have been able to seize opportunities to do more to help during this crisis, and those who are struggling to adapt and maintain their normal operations. I don’t think most people appreciate what a big difference modern business management software can make on a company’s agility and speed.
For my next question, I’d like to turn to supply shortages caused by the pandemic. How are you seeing cosmetics manufacturers activate alternate sources of raw materials supply?
AD: Disruptions have cascading impacts, so companies are creating risk management plans to take into account shortages of alcohol for cosmetic use, the availability of raw materials and packaging, the approval of back-up suppliers, and the final hand-sanitizer formula compliance.
Indeed, faced with the shortage of alcohol for cosmetic use, companies are quickly switching to another alcohol quality such as non-denatured alcohol used for human consumption or a bioethanol source.
This crisis is exposing how very few organizations are able to evaluate their supply chain beyond their first direct level of available suppliers. Linear supply chains prevent organizations from getting end-to-end visibility of secondary suppliers to secure additional critical inventory and capacity. Companies are being forced to consider how they would refine their inventory strategy to mitigate the risks of supply shortages — balancing a number of factors such as assessed supply base risk, cash flow, perishability.
Modern digital supplier quality management solutions are required to trace supply networks reliably across multi-sourced raw materials. Getting visibility on suppliers status, performance, audits, SCARs and building management dashboard have supported faster decision making and enabled delivery of hand-sanitizer products within acceptable time frames.
VI: As companies begin planning for their workers to return to their facilities, how are cosmetics manufacturers ensuring worker protection and a sufficient level of training?
AD: Insufficient staffing and quality measures may represent big hurdles to maintaining business continuity during such global disruptions. Like perfumes, elements of hand sanitizers are often flammable or combustible. This made perfumes production lines, which were already equipped to handle such materials safely, easier to reconfigure to produce hand-sanitizer products. This reconfiguration also required new training to maintain a high level of compliance and security. Companies with a robust virtual training tool were able to quickly ensure that the right people are completing the right training at the right time, such as procedures for the use of personal protective equipment and new social distancing requirements.
VI: Some people have expressed doubts about the quality of these quickly produced hand sanitizers. How can I be sure that my final formula adheres to applicable regulatory requirements?
AD: This is the responsibility of regulatory affairs. Cosmetics regulatory affairs managers should be able to, at a glance, check the maximal concentration of use of ingredients for a formula depending on negative and positive lists of regulated ingredients. It’s crucial to understand formula compliance based on each country’s requirements for each ingredient or active substances.
In the Covid-19 context, the origin of the raw materials check, and especially alcohol, is fundamental. In order to release compliant alcohol-based frame formulas, companies utilizing digital solutions to manage regulatory information and process have a big advantage. They have the flexibility to create new ingredients restrictions such as “suitable for a disinfectant purpose according to country guideline” and can easily check for instance if ethyl alcohol is US Pharmacopoeia listed or if it is listed on the ECHA‘s approved suppliers, on Annex 1 of regulation (CE) n°110/2008 or produced under the 15376: 2014 standard. Finally, compared to a maximal concentration of use, digital solutions enable regulatory affairs to check if the lower range of concentration for each ingredient is reached in order to only put compliant hand sanitizer formulas in the market.
VI: With more regulations come more mandatory requirements for claims on labels. How can I be sure that I have correctly put all the mandatory precautions of use, warnings and hazard pictograms?
AD: First of all, manufacturers should not make claims in labelling or advertising that their products can treat or prevent specific diseases, including Covid-19.
Even subject derogations, hand sanitizers must still be labeled with mandatory precautions and directions of use and warnings, as well as storage conditions, depending on each country's guidelines.
The final wordings on labels must be adaptable to the product composition. Digital product claims management solutions enable collaborative document authoring, which gathers all the required labeled accurate information linked to product composition, such as the mention of active substance concentration (V/V). Such solutions integrate development, approval, and usage that must give confidence to cosmetics manufacturers in hand sanitizer claim management.