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R&D Cosmetic SOPs
Hi All,
This might come off as naïve, but I was just hired to essentially put together all the SOPs for a smaller private label cosmetics company. I have training as both a Quality Control/ Analytical Chemist as well as a Cosmetic Chemist, but this is really my first foray into anything writing intensive outside of formulation. I have a good knowledge base of cGLP and cGMP as well, but I have NO idea where to even start with all of this…
I’ve consulted a lot of online sources such as OSHA, EU regulations, FDA sites, etc…but it is nothing really relevant to what I’m looking to compile. I don’t want to let this company down, there is so much potential here. Getting the place into organized,working order is like herding cats.
Can anyone point a very disoriented QA Cosmetic newbie in the right direction?
Thank you so much.
-Val
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7 Replies
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This is the sort of thing that consultants charge a pile of money for - and pretty much every company considers these documents proprietary.
I might be able to help you write one or two, but an entire facility’s worth? That’d be a full-time job for 6 months or so. -
Exactly. I don’t think they understand how big of an undertaking this is. Sure, I can get the SOPs done for the labs, but manufacturing and such? Chore is an understatement…I am NOT being paid enough for it at all either.
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Bob is right, that is a huge undertaking.
I’d start with first identifying all the areas / procedures that require SOPs. A mind map would be good for this but I would include…1. QA / QC - tests done on raw materials & finished products2. Product development - tests done while making products (performance)3. Required testing - Stuff you need to do to launch a product (e.g. stability, safety, etc)Once you get a list of every possible procedure you could reasonably imagine, then you can rank them by the amount of work required to write them.Then you could decide which ones to start writing & get started.Then you have to validate them.3 years later you should be in pretty good shape. -
Just to give you an idea of HOW small this place is, they don’t even have a UV-vis, FTIR, or HPLC for any analysis. The only quality testing that gets done is basic melting point, pH, and physical traits. It’s VERY limited.
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Hi @ValChemistLB. Check this link: http://www.asean.org/communities/asean-economic-community/item/asean-cosmetic-good-manufacturing-practice-gmp-training-modules-no-1-to-no-13
One of these modules is about documentation. It can serve as a guide to help you in writing those SOPS. -
Thank you! [-O<
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Perry is absolutely correct about the size of the job as well as the way to approach it.
Several sources can provide you with a basic Outline/Table of Contents for a Basic cGMP/QA/QC Manual. One could start with that and use it to assign placemarker SOP Numbers for each section. Then you could start with a Introductory SOP defining the scope, function and background of your SOP Program.
We did this successfully at a plant I worked at. We wrote the Introductory SOP and then assigned Representatives in each work center to sit on the review Committee and develop the initial SOP’s. Six months later we have a working cGMP program and at the 2 1/2 year mark it was refined and comprehensive.
Even once it was finished, the Committee still met annually and revised the SOPs as needed.
Again this is a lucrative area for Consultants as they charge dearly. However if this is an area you MUST improve upon in your facility, the cost could be worthwhile.
Quite important with a cGMP Program is to use it. I have toured plants where they have a cGMP Program but it is for show and not followed. To make this type program effective you must train effectively. SOP’s are often perceived as BS that serves no purpose. If you train them to understand the whys and hows in a clear manner they will work. We empowered people in each work center to understand and follow the SOP’s. When done correctly it will create an effective “culture” of cGMP.
Lastly have checks and balances and ensure QC checks and logs are completed. B in the mindset of “if it wasn’t recorded, it didn’t happen.”
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