′GMP′ for Cosmetic Products ISO22716: The Top 5 Weaknesses.

The most commonly applied set of GMP for cosmetic products is laid down in ISO22716. From a regulatory point of view it is a pivotal standard when it comes to market access of cosmetic products in several countries. But how much product quality assurance does it really ascertain? What does the reality of ISO22716 really look like? Let′s take an honest look, and then make conclusions on how cosmetic producers should understand cosmetic GMP from the ISO norm.

In order to understand the value or the weaknesses of the ISO22716 standard one must first grasp why GMP is even done: for product quality assurance and consumer risk containment.

The Risk Potential of Cosmetic Products

Cosmetics may be considered by regulators as products with a certain degree of risk to consumer health when improperly manufactured or when contaminated. Skin irritations, overly ingestion of volatile components, allergic reactions to foreign components due to carryover from other products during production, or even infections can come from insanitary conditions and improper quality assurance in cosmetic′ production.

Other than for example pharmaceutical products, cosmetics sort of luck out on the fact that these things are rather unlikely to show any clinical effect or really consumer damaging consequences - or at least only few consumers would point their finger at their favorite cosmetic item for negative side effects. Even if so - consumers seem to cut more slack to cosmetics than to any other product, not knowing that an intolerance may well come from bad manufacturing practices rather than from a personal intolerance.

A cosmetics consumer simply is not the same as a patient, not even the same as a consumer of food who really needs to eat (consume) to survive. Cosmetics are typically not ingested, swallowed, eaten or injected. That apparently makes the quality management need less stringent and actually fairly easy compared to other consumer product dedications.

Weakness #1 Inferior Assurance of Product Composition and Characteristics.

The kind of raw materials and the sheer number of components that go into a cosmetic product are so far off from what consumers would naturally apply to themselves, that it seems odd that any potential threats or product quality issues from industrial handling of such materials in a production environment can be covered by the ISO22716.

Interesting enough: the key goal of ISO22716 is really not to ascertain product composition. It may be an implied goal in the overall tenor of the standard, but there is no targeted system in cosmetic GMP that intentionally goes for this. Whether or not a cosmetic product can make a claim to a cosmetic effect does not need to be ascertained in consistent quality of batches of a given product. Product quality can be ascertained via sampling and testing alone - a process validation is not required. And that seems a rather poor testimony to a standard that carries "GMP" in its name.

Weakness #2 No Requirement for Full Cleaning Validation!

Unfortunately this is true too: the standard requires cleaning agents and sanitization agents to be effective - but what does this mean? And how is this any solid basis for any given ISO accreditation auditor?

And what is worse: by the norm′s definition cleaning really only needs to remove "generally visible dirt". Do I need to be worried that any(!) cosmetics company on this planet has "dirt" on their equipment? In addition to products residue...?! And cleaning should remove that "generally visible dirt"? Why does this not(!) put my mind at ease when I go to buy an aftersun lotion knowing that the manufacturing company has removed "generally visible dirt" before they started its production?

What about carryovers of substances from a previous product that could be a problem to the consumer of the following product? It should be a given that there is much much more to adequate cleaning - even in a cosmetics area - than removing only what still can be seen by the eye of an operator. This in my view is a huge gap and a risk the regulators seem to rather willingly take in accepting ISO22716 as it is now.

Should we even start to speak about microbiological cleaning validation...? Another blatant gap in the ISO22716. It is getting rather embarrassing.

Weakness #3 Lack of Clarity for Production Environment.

The ISO 22716 does not specify clear requirements for the production environment where open product is handled. Cosmetic producers operate ISO class 8 or ISO class 9 environments where bulk and filling operations are done. But it is not required by ISO22716. And noone really knows why ISO 8 or ISO 9 are commonly accepted. It just is. And what is more: microbial monitoring is not really regulated in the ISO22716 either. A company can do whatever they want, set up alert or action limits ad libitum really. The monitoring coverage required by ISO22716 is essentially non-existent. And I find that disturbing. It must not be forgotten that bacterial contamination cannot be detected in a product like other impurities. And pathogenic species are consumer safety relevant - even in cosmetic products!

Weakness #4 Handling of Raw and Starting Material Suppliers.

ISO22716 does not expressly require on-site audits at cosmetic raw material suppliers. This is a huge gap, because it leaves a significant risk of unknown impurities entering any given cosmetic products. Companies often rely on supplier questionnaires and ISO9001 certificates for approval of raw material suppliers. And neither one provides sufficient assurance that a raw material is pure enough or that certificates of analysis are reliable. And ISO9001 does not tell me the smallest thing about how a supplier manages product quality of the material I purchase there. It just does not. On top of this, raw materials are not even necessarily tested for identity in a cosmetic GMP system. Even here the ISO22716 is not very clear, and thus the common practice looks accordingly. This should change.

Weakness #5: How Good is the ISO22716 Enforcement?

In my experience the ISO22716 is not properly enforced and in my view it really cannot be. The reason is that it is a non-governmental supervision scheme carried out by private certification companies (not adequately independent for the intended purpose), and because the standard is not strict and detailed enough at some of the most consumer critical topics. In one instance I found a cosmetics producer with wood flooring...! WOOD FLOORING!!! And yes: an ISO22716 certificate was issued here too. How is such a thing possible?

Sometimes it seems that ISO22716 auditors come from a too clause-oriented way of auditing, rather than also challenging if the way a cosmetics manufacturer implements all those norm clauses really can even be effective for product quality assurance. Just like any good supplier auditor also would.

ISO needs to revisit their way of ascertaining that these standards are first of all defined and written better concerning their content , and secondly how they are enforced. Industry and consumers rely so heavily on such certifications that they simply need to hold much more of what they imply and promise.

Consequences for Businesses: Take Charge of Your Product Quality!

Businesses should not blindly rely on ISO 22716 certificates assuming that the products manufactured are all that pure and safe. In my project experience and from my experience from our contract audits & inspections activities, this is simply not the reality. If You want to be sure, You will need to perform or purchase Your own quality audits at Your supplier and subcontractors.

If You are a cosmetics quality manager or a business owner or other stakeholder in this: The weaknesses listed in this short article are by far not exhaustive. Under the surface many more issues are out there - and one day those will cause consumer harm in one or the other way.

People who use cosmetics trust - don′t even question quality of cosmetics much. But this trust and carefreeness is not limitless.