Good Manufacturing Practices
As I was preparing information for this page on Why I No Longer Promote MLM Liquid Zeolite (part 2) I started wondering… what exactly ARE GMP (Good Manufacturing Practices) standards.
My first stop was to Wikipedia for a definition, and an explanation. One thing I need to point out is that even though some of the quotes talk about a drug, nutritional supplements fall under this description, and even if they didn't, the MLM Original Liquid Zeolite Company has clearly stated, a number of times, that they follow STRICT GMP standards.
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidance that outline the aspects of production and testing that can impact the quality of a product."
"Although there are a number of them, all guidelines follow a few basic principles.
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensureconsistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
- Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
- Operators are trained to carry out and document procedures.
- Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
- The distribution of the drugs minimizes any risk to their quality.
- A system is available for recalling any batch of drug from sale or supply.
- Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence."
As I pondered that definition, I was logically drawn to a few questions that definition raised in my mind. Allow me to explain. Here is one of the first of recorded bits from a call that The Original Liquid Zeolite company had a week ago. (more information about that is in the linked page I provided above). The call addressed 2 main issues. One of them, and the one I want to discuss here, was the fact that the product in the bottle is 'clogging the tip".
MLM Company Liquid Zeolite Clogging the Bottle Tips
This recorded clip features 3 speakers commenting on a few issues that are happening with the product and a new manufacturer, which includes a clogging tip, and changes in mouth feel, odor, color and some other parameters.
They go on to say that over the 6 years that the product has been produced for sale, they have, on numerous occasions, been faced with this issue of the bottle clogging the tip. They have also have had, according to thezeolite experts on that call, changes in color, mouth fee, odor etc. many times over the past few years.
As well, several lab tests done on the liquid zeolite product independently, revealed that, at least in the bottles tested, varying amounts of zeolite were found in the MLM brand of "original Liquid Zeolite".
So after listening to the above audio, and reading the description of what GMP standards are I have a couple of questions.
- If the company does have documentation on every single batch that shows compliance with GMP practices, including that theoriginal liquid zeolite product meets all label claims, then why wasn't that shown when I sent a simple email to one of the management team. Would showing the document not have stopped the investigative process right there? It seems that 6 months of trying to get some answers should have generated some kind of proof long before anyone would have time to draw conclusions.
From: Shelley Penney
Sent: Wednesday, April 06, 2011 5:12 PM
To: General Manager North America
Subject: Have you seen this? NCD analyzed by independent lab
An independent lab tested our NCD and found 2300mg in 10 Bottles (an average of 230 mg per bottle)! But we say 24mg per dose which means there should be 2400 mg in EACH bottle. Can we get an answer on this?
- If "manufacturing processes are clearly defined and controlled " and "All critical processes are validated to ensure consistency and compliance with specifications" according to GMP standards, then
- a- How is it possible to have 3 separate lab tests, at 3 different labs in 2 different countries, testing from 3 different batches all find markedly different amounts of the ingredient 'zeolite' in a bottle of the product? That doesn't seem very consistent.
- b- How is it possible that over the past 6 years this company has repeatedly had issues with the product clogging, to the point where it has come up (according to that recording) multiple times? That doesn't seem consistent either.
- If "manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary." according to Good Manufacturing Practices with every single batch of product the company puts out, why doesn't this issue get resolved over multiple occurences and many years? Also, how does this kind of faulty product (product that clumps, and clogs the dropper hole) leave the manufacturer in the first place. I would think that, in a product that had testing performed and was shown to pass all of the tests to comply with GMP, this kind of issue would be discovered and not sent out in the first place.
- If "Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected.Deviations are investigated and documented." Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence."When I first brought the original zeolite test results posted on the internet to the attention of the company, and the tests speak to "quantity and quality", why wasn't this investigated per GMP guidelines, and in case I am mistaken and it actually WAS investigated as per the GMP this company adheres to, why hasn't anyone shown the results of such an investigation, in answer to the many questions that have been raised?
Questions Swirling Around Original Liquid Zeolite
Unfortunately, I feel that there are a lot of questions, and I can't seem to be able to find any answers. I invite any one who can answer my questions about the Original Liquid Zeolite product to please send me the documentation so I can show my many readers that there really are answers to these questions. I feel certain that someone will email me with the documents, and I promise to post them here when I get them.
My husband is an automotive mechanic, and owns his own business. He deals with car parts, and lots of them. If he needs to he can get a document on a single BOLT that he ordered. Material Test Reports (MTRs) are a lot/heat specific document that includes the dimensional, chemical and mechanical test result of a fastener.
What does that have to do with this? Nothing really, except that if this kind of document is available, on request, for a bolt, and the company is required to provide it if asked, it seems that some similar arrangement ought to be in place for a nutritional supplement like Original Liquid Zeolite.
Absolutely MUST read:
- Liquid Zeolite – Why I No Longer Promote It
- I Do Not Sell Liquid Zeolite (part 2)
- Liquid Zeolite Rumor Mill
- Good Manufacturing Practices and Original Liquid Zeolite
- Who Is Attacking Me?
- There is NO patent on Waiora NCD
- Zeolite Autism Study – FDA Registration Does Not Exist?
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