aperson
Forum Replies Created
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did you ever figure this out?
- different growth media
- different methods
- one of the labs is contaminated and doesn’t realize it yet - (false positive)
- one of the labs is cooking the books (false negative)
- speed of arrival; one lab is closer than another
send the sample that your lab says is contaminated, to the lab that says their sample, isn’t.
if it comes back clean, then one of the two labs has a serious problem.
prior to sending out the sample, you should request exact details from each of the labs, as to their testing methods, and growth media. this is so they can’t backtrack.
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wink
> And added to that, we are the ones that need to make a profit within the framework of the GMP Guidelines.
indeed if the FDA was willing to subsidize the price differential between a 1.50 shampoo, and the 150 dollar “hospital” shampoo, out of their generous budget (and take), I might be inclined to produce it under pharma regs.
… seeing as they are not so forthcoming with their swag. screw’em.
mandates, without funding, is legalized theft. inspection “notices of violation” not authorized by law, or gmp regulations, is criminal incompetence (at best), straight extortion at worst.
> “I now challenge you to check all the specs of our ingredients, and tell me how many specify RH storage conditions?”…This issues was not included. Case closed.
well done. good luck on the rest of your “issues”. -
good article on various forms of vit-c here:
http://thebeautybrains.com/2014/05/which-kind-of-vitamin-c-is-best-for-skin-the-beauty-brains-show-episode-31/ -
for processing concerns sure. you can work around RH issues, in process.
note my actual argument:
“If you can rip them off the wall, and nothing changes (with regard to your manufacturing), then you don’t need either.“
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Given that he’s in Malaysia, I can guarantee you he’s at some point switched his suppliers to buy a slightly more expensive version of an ingredient, simply to address a processing concern related to RH (either packaging, additive, or conversion from RM to oil carrier). Guaranteed. No question, in my mind. If not him, than his supplier.
… the point here, isn’t that many products have RH specced; the point here is that ABSENT A SAFETY ISSUE, the person who really knows whether or not that RH meter needs to be controlled, is the owner of the plant. Not the inspector.
—If he was doing OTC, different story (where’s API’s, need to be dispersed, and may not be homogenized or milled (either due to solid phase, or “molecular” sensitivity to high shear or temperature).
But, he’s doing shampoos. In water.
KISS. Don’t make it your process, more complicated than it needs to be.Thats the difference between an “inspector” and the responsible person, in a plant. The former, think’s hes being “teachable”, when he don’t know shit; and the latter has the best education money can buy.
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> we have not stated min/max RH, and (2) these Hygrothermometers need to be calibrated by a licenced company on an annual basis.
typical bs.
they see a piece of equipment, and their knee-jerk reaction is where is your “control”. I doubt highly any of your processes, or materials need to have their RH controlled within limits (for safety reasons).If you can rip them off the wall, and nothing changes (with regard to your manufacturing), then you don’t need either.
which would be my argument. if you’re satisfied that removing RH meters is a solution to your objection (no min/max, no calibration); then why would you have a problem with them staying where they are, uncontrolled? they have no application, with respect to the GMP, and therefore are outside your purview.
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you have to wonder, why you are even having this conversation.
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This is associated with a specific product class called “spiderweb” hair gel. I ran across this term when doing some preliminary market research. Nice to catch the technical terms for it
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> I only hv basic chemistry in my secondary school.
what country? basic chemistry, depending on which country you studied from, can be quite advanced. Have you studied organic chemistry, in the lab?
> done a lot of youtube viewing.
> hv some basic ideas of what I want to do.
everyone, starts somewhere. prepare, for a lot of reading -
> I used to make Retinol/Retinal.
any chance you went the cleaving beta-carotene route? -
not as stupid, as you first think; and not as difficult, either.
whether or not its marketable, at a premium….
now thats the trick question, isn’t it?
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humidifiers work, when your environment is artificially dry (low RH); either due to AC (or winter), or to heated air. old people typically encounter this, which is usually accompanied either with sinus problems, or dry itchy skin.
usually the counter is either to install some sort of humidifier, or have them (in cases of skin dryness) use a humectant with a lot of water, or barrier cream (after the shower).
the problem with humidifiers, is that:
* a lot of the low end ones, are problematic from a sanitary perspective. particularly the ultrasonics, and cold-steam.
* you don’t want too much humidity, because then yeast, mold flairs up - the idea is to correct the defect, not turn the air into a swamp
* hot steam heats up the room, in summer (which is usually counter to why the air is arid in the first place i.e. cooling).
* humidifiers, in winter, lower the temperature (as they vapors hit the condensation point, they pull heat from the room, and also, high humidity air increases heat loss).…use of creams (moisturizers) don’t work long-term; the best is a barrier cream on fully hydrated skin. you can spot treat problems where there is a spike in heat (either drying out directly, or through extended use of AC), but the ultimate solution is to fix the problem (humidity of the air).
@perry
> 3. Take readings throughout the day with subjects who stayed in a controlled environment room (humidity & temp).
> 4. Take readings the next day to see if TEWL was higher than baseline. For the 24 hour lotion it was, although only slightly.TEWL readings using an evapirometer? I was reading a paper that studied the dynamics of TEWL (water loss), and they suggested that modeled TEWL loss, provided a better way of looking at how it was happening, due to nonlinear effects of moisture being pulled from the skin. i.e. rapid water loss, begets rapid water loss, until the system equilibriates and you get this slow decline of TEWL. But I think they indicated something like 50% decrease in a minute.
https://onlinelibrary.wiley.com/doi/full/10.1034/j.1600-0846.2002.10342.x
Methods/Results: The model, which is based on general results and methods of transport phenomena, has been calibrated and validated by experimental tests, in vivo, with the use of an evaporimeter. Both the theoretical model and the experimental results show that the release of excess water that accumulates in the skin following an occlusion, is a fast transient phenomenon, which has a characteristic time of the order of minutes (the initial decay is very rapid indeed, in less than a minute the TEWL value may decrease by more than 50%). On the other hand, the characteristic measuring time of the evaporimeter may be as large as 30 s. Therefore, as shown in the paper, the use of the evaporimeter for measuring the initial values of TEWL upon immediate removal of the occlusion is not reliable. When a transient phenomenon cannot be fully described by a measuring device that has an initial characteristic response time of the order of the characteristic time of the phenomenon, a mathematical model, which describes the dynamics of the phenomenon must be developed. Then the measurements taken after the measuring device is stabilised may be extrapolated to the initial times by the use of the model, thus allowing a full quantitative description of the phenomenon vs. time. Finally, the experimental results show that a baby’s disposable diaper, when loaded with water, behaves like an impermeable occlusive cover on the skin.
Context of the search was related to a forum post, regarding silicones as a film-formed barrier preventing TEWL.
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> I’m now wondering if it could have reacted to something on the skin as
well? Both people work outdoors around various chemicals, one is a
farmer and the other is in a vineyard…just an fyi, being slathered daily with chemicals, can actually induce a sensitivity to trace amounts. chlorine, and ammonia being two as I recall. i.e. your two friends should have an allergy test to see if they’ve become sensitized to common chemicals.
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http://www.informationng.com/2017/09/must-read-may-risk-nigerians-cooking-transformer-oil.html
> February 1st, 2015 I sat across the Senior Environmental Specialist
of the World Bank (Nigeria) and he explained what a great choice I had
made in my field of study. As our conversation gradually came to a
close, he casually mentioned what he was working on. “I am currently
working on PCBs” . “Nigerians have started using transformer oil to fry
food, because it lasts longer.> We are not the only ones, as other African countries like Kenya,
Uganda, Tanzania, Zimbabwe etc. have also been doing it. They go as far
as going to the transformers to get the oil out. Most of the food
vendors that use it in Nigeria go to areas where there is a transformer
and pour the left-over from the drums.” He said. I froze, maybe I didn’t
hear him well, I thought. Did he just say transformer oil?facepalm.
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thanks. did you do any foundation work?
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abbreviated from pm, but snippet posted because it might benefit some youngster.
-snip-
Depends on:- what your providing how technical (i.e. whats the supply vs demand like)
- how sensitive they are to failure e.g. value at risk (more sensitive = higher price),
- how sensitive they are to timing (hard deadlines, or short deadlines, = higher price)
- whether or not “padding” is possible (taking a cut on “subcontracted” services on the backend, billing out fluff hours etc),
- whether or not your performing “work” or consulting (doing research, presenting a finished product).
- and how many hours can be expected relative to a ‘reasonable’ schedule.
-snip-
I generally avoid padding (preferring to take my “wins” on stuff I already know how to do (or have done), and billing out at a fixed project rate (e.g. if I know it will take me an hour, and it will take someone else, eight, I negotiate eight-hours worth “per project” rate).- repost addendum-
client don’t care because his alternative, is eight hours of work of uncertain quality if you need the full eight, its because you don’t know what you’re doing. Uncertain risk, vs certain cost. Certain cost, will win out.-snip-
the hourly rate, is cut a couple of different times (haircuts); so you really need to understand how to structure it, in order to make it work.-snip-
there are several haircuts:- once for administrative overhead (administrative cost as %/hours) - you can do this either for potential billable hours, or total hours
- once for utilization (how many potential billable hours you converted to actual billable hours) - low utilization, REALLY jacks up your “hourly rate”.
- once for discounting (how often you cut your rates) aka profit margin
- once again for taxes.
- once again for “billings collection rate”.
- repost addendum-
you can find approximates for each of these stages of haircut, fairly easily, or by estimating your cost structure, and plausible revenue. don’t pick unrealistic percentages; do discount for time off etc. realistically, hours worked, vs potential billable hours, vs actual billed hours, vs billable hours collected, is where the key variation exists. these numbers will change as you gain more clients and can be “more selective” in who you do business with.
-snip-
DO NOT, take low paying consultancy jobs. Its simply not worth your time. You’ld be surprised, at how much charging a premium rate, really changes your clients attitude to your time (and your expertise).This is a very common mistake for people starting out, but the numbers, are the numbers. And if you’ve gotten to the stage where you have SOME knowledge in order to consult (excluding shit consultancy jobs), you should be able to make a real living.
At the end of the day, you’re a line item. You’re not even an employee. You are a cost of doing business.
- repost addendum-
thats consulting in a nutshell.@Perry
good back-of-the-envelope explanation
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> We will have to agree to disagree.
Not really. You simply don’t have any experience. You want to claim your avoiding it through “skill”, but your really just giving them whatever they want.This, is not skill, this is the absence, of skill.
> Looking at my to-do list, you have already exceeded the time which promotes this dialogue.
Very good. First sensible thing you’ve said.
> They are not the enemy.
No they really aren’t. They’re just obstacles. Hazardous, obstacles. To be worked around, despite their best efforts to be something other.
Its like when I cross the street, and theirs a big pile of steaming s&*t, I don’t go out of my way, to step in it.… I walk around. Shortest path, notwithstanding.
Different strokes, for different folks. On that, we can agree to disagree.
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> As such, my practical experience is being the appointed liaison to an FDA Inspector
You’re missing the point; I ain’t questioning your credentials on running a tight ship; I’m questioning your experience, under fire. By your own admission, “you’ve never had a problem”, right? Give’m whatever they want (in essence), right?
> The FDA Inspector will present his/her ID and they will tell you the primary reason they are there.
Nope.
> In the end, no offense but I believe that you damn the torpedoes, full speed ahead, us versus them attitude will become an obstruction to your Regulatory compliance.
F*&k’em. Mafia rolls up to my door, mafia gets treated like the mafia. Regulatory “compliance” (cough) I leave to you. I stick by what the law actually says, and what the regs actually say. Not a single, iota, more.
> My attitude on compliance? 100% compliance. Do it right.
S&*t I love it. Provided its what the law actually calls for. And the actual promulgated regulations in effect. Not, guidances. Not “suggestions” (out of their extensive “inspection” experience at other places). Not upcoming regs not yet in effect. Not the wrong regs. Cite the fucking reg. and be prepared, to have an informed professional ‘discussion’; with legal involved if necessary.
> My attitude towards the FDA? They are not the enemy.My attitude is their incompetent, corrupt, petty, highly-political, and powerful. NOT, a good combination. Particularly when you compare their enforcement on small and mid-size manufacturers, vs large manufacturers.
I’m not a big fan of rollover, take it up the ass without vaseline(1), as a sign of “cooperative” attitude.
> In the end, no offense but I believe that you damn the torpedoes, full speed ahead, us versus them attitude will become an obstruction to your Regulatory compliance.
Regulatory compliance? Thats the easy part. Getting them to comply with their regulations? Thats the dark arts, right there.
One, you don’t learn, if your ass is constantly end-up in the wind.Now there is at least three different posters, with somewhat similar concerns, regarding regularity uncertainty, with respect to promulgated regulations, regulatory compliance inspections and the so-called “cooperative” attitude of the FDA. Wildly different background I’m sure, but generally, in agreement on the main points.
Thats what we were discussing. The dark arts. Apparently, you don’t need’em. More power to you, knock on wood, hope you never need them.
But your situation, is not the same as everyones situation, yes?
> Most cases where I see someone rail against the FDA they are so far out of spec that they are fearing correction. Small start-ups that foolishly choose to manufacture themselves without formally trained staff will get dinged, as they should
Thats your mistake. Don’t let your presumption, get in the way, of reading the actual point being made.
I posted simply to confirm DavidW’s point (and expand on the reason why); and to concur with DrBob who commented on that expansion. None of which, I think, you actually disagreed with, right?
This isn’t a regulatory board; this is a chemists board. To the extent that chemists of small firms, have to deal with this, and they make an accurate point, I will probably post a concurrence, or expand on a point. Here it is the bare minimum, to get the point across, and possibly, inform the reader. If people want to carry on an extended conversation, thats what PM is for.
Lastly:
> In fact, in many cases, you and the Inspector can turn it into a teachable moment.
I’m not looking for a “teachable” moments. When I want to learn something, I consult professional grade resources and study the matters in depth.…and I sure as s&*t, am not on the payroll for the FDA, to train their inspectors.
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(1) sorry, petrolatum! -
> In the video, a worker wipes a chemical tank. Seconds
later, the tank becomes engulfed in flames, with parts of the the
man’s clothing catching on fire as he runs from the explosion.> According
to fire officials, the massive fire began when static electricity
ignited a flammable liquid during the manufacturing process -
video of the first explosion. Not sure what set it off, it went up quick. Looks like toweling down the plastic bin, in the presence of vapors i.e. static electricity?
Could also be chemical (something in the wipe, mixed with spilled solvent?)
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> I have NEVER had an issue with the FDA
So whats your practical experience then? In a conversation where the FDA is adversarial (or deliberately obtuse), what practical experience do you have?
> In summary, believing the FDA is an evil force or part of a bigger conspiracy is a waste of time. If anything, they are a much larger presence in the Prescription Drug Industry where I first started
Might be why you don’t really see “complying” as a problem. You come from pharma regs. Except, under the law (FD&C), and under their regs, not everything is pharma. Thats the point. Trying to convert everything into pharma, selectively and arbitrarily, is the problem.> following their guidance
guidance ain’t binding, EVEN under their regs. you shouldn’t have to follow their guidance, simply because they think you should. Shit, if anything, you are the expert, not them, no? You don’t strike me as some neophyte chemist.There comes a time, when the regulation, ceases to be productive (or lawful). If you are entitled to produce and market a good, under the law, and under their regulations, shouldn’t this be enough?
So yeah, I like cooperative. But that ain’t what they’re offering.
Shit if anything its being run like a criminal extortion racket. I wouldn’t seriously consider running any business regulated by the FDA, absent an excellent lawyer, on speed dial.
… and that is WITH nothing to hide.
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> the first question in my mind was: how can UV filters get from the skin into the blood, and specifically affect the sperm?
it doesn’t; the most obvious conclusion, is that sun is good for your sperm count/quality
gives new meaning to “sex on the beach”; I wonder if you can get a prescription for that from your doctor as a “medical necessity”.
LOL.
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@”DRBOB@VERDIENT.BIZ”
> Right now its a crap shoot.
says it all, don’t it. I just made the same point in PM to another member. -
LOL.
Its crap.
If you had pyrex (real borosilicate), you could thermo cycle it all day long; the tempered glass is guaranteed to shatter under similar circumstance. Their marketing spin (its twice as strong) is a load of garbage (akin to saying this metal is twice as hard, and therefore won’t crack when you hit it)
This is marketing fluff trying to explain away what really happened
Thats why all the labware, stayed the same.
But all the “consumer” grade stuff, disappeared.
Thanks for the update, I had no idea this was an “industry-wide” event. I figured it was a Chinese company trying to capitalize on a brand while pumping out cheap crap. Not uncommon.
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> Besides I have always found they say we can’t tell you yes and we can’t tell you no.
absolutely 100% correct. Unless you are getting an agency ruling from the higher ups, FDA policy specifically prohibits lower echelon agents from “formulating policy” for the FDA.
Backed, by many court rulings to that effect (‘deference’ to the agency).
Or more plainly. FDA inspectors can lie their ass off, with absolutely no repercussions because reliance on their statements, has no binding authority.
I couldn’t make this shit up, if I tried.
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> Well, if you are going to produce a finished product, you have to get inspected by the health department.
I looked briefly at opening up a plant in Mexico. This is why I asked> This is a very old message by the way.
Doesn’t show up with the warning And I reopened it to explicitly hilight the excellent point Microformulation made with respect to the botanical activity not necessarily being cosmetic, rather than “ingested”. Rosehips is another example (similar to willowbark), as I recall.
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> The confusion happens because willow bark extract contains anti-inflammatory salicin, a type of salicylate. When orally ingested, salicin is converted by the digestive process into salicylic acid. In a laboratory setting, salicin can be chemically oxidized to yield salicylic acid. (Fun Fact: Salicylic acid is the precursor to aspirin.)
a fair amount of “botanical” ingredients, are being included and promoted as cosmetically active, when they are in fact, only bioactive if ingested. not to put to fine a point, on his point.
> If the seller expects a consumer to get “wink, wink, acne”, the FDA Inspector surely will as well. They are not the enemy and pretty sharp as government employees go.
In the US, they have a frightening amount of power (for a level of incompetence that borders on criminal). Its like the Pope. If they say the Sun rises in the West; it rises, in the West.> Now Clive @Belassi may weigh-in, but as he will tell you, he lives in the land of Mexico where the FDA fears to tread!
Do tell. Is this from practical experience (as in you’ve run a lab in Mexico)? Or just the pharma rebasing from PR leads to too many plants to inspect?@belassi - hows the FDA “presence” down in your neck of the woods?