How does Lush UK get away with it?Posted by mikethair on September 9, 2018 at 9:57 pmWe have a GMP certified (and regularly inspected) cosmetics production facility in Malaysia. We jump through the hoops for exports to the EU where standards are high. But check out the Lush UK factory tour video below. They seem to break every GMP rule in the book.Any insights into how this can be? I’m perplexed, they even have outsiders wandering around the production areas. And not one hair net in sight.
MemberSeptember 9, 2018 at 10:11 pm
At that level of production I would already have automated the weighing.
MemberSeptember 9, 2018 at 10:48 pm
I think the fact that it’s handmade is a part of their marketing story.
MemberSeptember 10, 2018 at 6:21 am
I’m sorry, but WTF??? Are you kidding me, why are they still in the market with this?
MemberSeptember 10, 2018 at 8:28 am
While I don’t necessarily agree with the clothing, lack of hairnets and face masks not to mention raw materials literally standing on the floor.
I am unsure of how this video indicate multiple breaches of ISO 22716:1007(E)?
MemberSeptember 10, 2018 at 5:21 pm
Perhaps they change things up when the inspectors come.
MemberSeptember 10, 2018 at 8:35 pm
Perhaps it is because of marketing soaps as natural?
Human saliva is naturally occurring
mucus = natural
sneeze and cough fluids = natural
hair = natural
dead skin cells = natural
sweat = natural
floor microbes = natural
Sorry, I couldn’t resist
MemberSeptember 10, 2018 at 9:50 pm
If I ever start my skincare line my slogan will be ‘Proudly with Silicones and Parabebs’ ?
MemberSeptember 11, 2018 at 9:27 amIn reality, if you check Lush ingredients they are not so “natural” (whatever that means).@Perry that would require a massive reconstruction for a visit by inspectors. I doubt it very much.@Sibech not sure if I agree with you. Some of what I observe would require a microbial regimeSo, from my side as the owner of a GMP cosmetics facility, still non the wiser. As @em88 says “WTF??? Are you kidding me, why are they still in the market with this? ” My thoughts exactly. Even without any microbial risks, this place would never be accepted under any GMP regime.Mark Constantine, the Lush founder, was originally making stuff for Anita Roddick (The Body Shop). After some time, the Body Shop then paid £11 million for the rights of Mark Constantine’s recipes. So this guy has been around for a while and knows the cosmetics business.
MemberSeptember 11, 2018 at 10:14 am
@mikethair I Don’t spend most of my time in the production I do troubleshooting with them, pilot plant scale ups, formulating and regulatory stuff.
I am certain that you are right about them being more than subpar, but please enlighten me;
Lack of cleaning (or easy access to doing so based).
raw material storage
And Allowing non-trained personnel in the production facility (which is also extremely cluttered and likely hazardous.)
Can you assert as being against GMP from that video?
As for how they get away:
it it might just be regulators rarely doing a GMP audit but who knows?
MemberSeptember 11, 2018 at 10:23 am
I analysed their ingredients and agree with @mikethair they are not so “natural”. They use parabens, SLES and PEGs. Their marketing claim is that their cosmetics is “Fresh and handmade”. My guess is that uneducated consumers think that “handmade” and “natural” (whatever it means) is the same. I actually think it’s a good trick.
MemberSeptember 11, 2018 at 10:54 am
@ngarayeva001 who needs “natural” anyway? - it’s performance inferior, it demonizes safe synthetics and arguably less safe as extracts are rarely well defined or toxicologically studied
if anything good is to be made about the “fresh and handmade” claim it is that using a “value added” claim from positives instead of the regular “without toxic chemical XYZ and chemicals all together” (even though they might did that as well)
MemberSeptember 11, 2018 at 11:46 am
@Sibech, I agree with you but as you correctly pointed out, it is almost impossible to re-educate consumers. Most people don’t know that parabens are preservatives but they “know for sure” that it is bad. And it’s actually not surprising. Every time I google an ingredient the second or third link is “Why xx is bad for you” followed by a chemophobic article written by some dilettant.
MemberSeptember 11, 2018 at 12:24 pm@Sibech without going too far into GMP requirements you have already identified a few critical issues.Addition areas are, in my opinion, layout and design of production area to minimise the risk of cross contamination and errors during all aspects of manufacture, filling and packaging.The weighing of starting materials should be carried out in a separate purpose designed weighing area.
The list goes on….
MemberSeptember 11, 2018 at 1:15 pm
@mikethair thank you for the examples!
Maybe I missed that part but what in the video showed weighing of raw materials right next to production (/not in a separate area)?
To be the devils advocate even though I agree;
What defines appropriate clothing and protective garments for avoiding contamination of the products?
Premise design should be based on the type of product, existing conditions, cleaning and sanitizing measures used.
Why does this not qualify the flat tables for bath bombs?
Technically the ISO requires only sufficient space And separated or defined areas (Again I agree there is not sufficient space, but isn’t that subjective?)
MemberSeptember 11, 2018 at 3:58 pm@Sibech cGMP encompasses a great deal and while in many cases it is still unfortunately not mandatory, it is crucial. I saw numerous issues as well.For a quick overview of the FDA’s cGMP Checklist, which the WILL go through during a site inspection, here is a link. https://www.fda.gov/cosmetics/guidanceregulation/guidancedocuments/ucm2005190.htm
MemberSeptember 11, 2018 at 8:18 pm
WTF??? I guess this is some sort of DIY tour like in chocolate factories, I doubt the production is as amateur as it shows, but still I wouldn’t show a rusty and filthy shelf with pride.
I guess deep pockets and good contacts get you this far.
MemberSeptember 11, 2018 at 9:04 pm@Microformulation Thank you for providing a link, it seems to be an abbreviated version of the ISO 22716:2007 with the addition of a definition of adulteration for the US.The EU is a bit odd on the GMP for cosmetics. You must produce under GMP, however, it technically does not have to follow ISO 22716:2007. In addition, you do not need certification as long as the product is produced following GMP guidelines (local regulations may apply and it is just EASIER to follow ISO 22716:2007 as an inspector may question your choice of GMP standard). However, how often an inspection occurs may vary from country to country.After watching the video, the first time I re-read the ISO 22716:2007(E) and watched the video again to spot new errors. Now I just went over the FDA list as well and rewatched the video, yet again (she is getting too many views from me I tell you).
With numerous GMP issues please assist me in completing the list of currently 7 apparent issues in the spoiler (to reduce post length):
- Openable windows (with/without proper screening - I cannot discern that from the footage).
- Lacking hairnets and facemasks for powder handling.
- Seeming lack of cleaning (or easy access to doing so based) & shelves in “Poor repair”.
- Raw materials stored poorly - for instance on the floor.
- Allowing non-trained personnel in the production facility
- Poor flow of production allowing for cross contamination and errors.
- Lacking separate/designated weighing area for raw materials
MemberSeptember 11, 2018 at 9:20 pm
@ngarayeva001 Something tells me they add a small amount which is negligible in the formula. Regardless they have to prove microbial stability to legally sell it on the European market so I can only assume yes (that, or they disregard the rules and sell illegal products - who knows)
MemberSeptember 11, 2018 at 10:26 pm
@Sibech I’d say the lack of fire extinguishers is the most important thing I noticed. (by the size there should be at least 3 or 4 visible and inspectors would still bitch about it) Or at least they are not signaled, which is another thing an inspector will bitch about.
The flammable stuff piled on the floor deserves a chapter on its own.
MemberSeptember 12, 2018 at 2:23 am
I bet the staff get RSI from making all those bath bombs by hand.
MemberSeptember 12, 2018 at 3:55 am
@Microformulation the thing is, I did walk over it (Not only did I go over the FDA shortlist but the actual ISO standard) and since most of them are documentation, which obviously is not shown, or subjective/vaguely worded, I am at a loss as for what else could be wrong.
I am even doubtful as for if the separate/defined RawMat weighing area is an issue as it is hardly shown in the video.
But by the sound of it everyone else commenting knows all GMP requirements well enough to mention numerous issues, so it appears logical to ask for help.
Log in to reply.