Homeopathy Dare! Video

Well, it may be a vain hope, but I have posted as well:

Mr. Medhurst,
I understand that you may be overwhelmed by the number of questions being thrown at you recently regarding Brauer's homeopathic products. If I may, I would like to focus on a single question posed by Richard in the Homeopathy Under Fire thread.

Richard asked, "How does Brauer do quality testing to make sure that the pills have, for example, Coffea 30C and not Coffea 29C?"

In your answer, you stated "The testing of the substances you mention is done on the basis of the manufacturing procedure involved. This complies with the TGA’s Good Manufacturing Practice code and complies with all other TGA requirements. If you’d like to know more about these requirements, please contact the TGA or look at www.tga.health.gov.au"

I did look at that site and it has much information obaout the licensing requirements and the frequency of audits that are done to ensure compliance with GMP. However, there seems to be a scarcity of information on what is actually done during an audit. For example, the website lists the following procedure for a typical audit:

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Typical TGA audit of a medicine manufacturer
Before the audit:
Lead auditor is assigned.
The audit team is decided.
Lead auditor notifies the company - no earlier than the week before the audit. An unscheduled audit may be considered where it is believed that the true extent of GMP compliance cannot be assessed otherwise.
Audit team reviews documentation including Site Master File.
Lead Auditor prepares an audit plan for use by the audit team.
At the audit:
Lead Auditor chairs an opening meeting with the auditee's management:
Members of the audit team are introduced.
The scope and objectives of the audit are reviewed.
The audit plan is discussed.
A short summary of the methods and procedures to be used to conduct the audit is provided.
Communication links between the audit team and auditee are established.
It is confirmed that the resources and facilities needed by the audit team are available.
Arrangements for auditor caucus are made.
A tentative time and date for the closing meeting and any interim meetings of the audit team and the auditee's management are established.
The accuracy is verified, in the case of a pre-licence audit, of the licence application details, especially legal name of enterprise, site address(es) and nominated persons and scope of activities.
Audit is conducted.
Audit team meets to discuss and prepare a Deficiency Report (laptop computer).
Exit interview with the company:
Lead Auditor gives overview of the audit and its outcome
Lead Auditor may provide the company with the Deficiency Report and encourages discussion.
Lead auditor requests written response to the Deficiency Report within 4 weeks from the date of receiving the report. Objective evidence of corrective action is required for critical and major deficiencies.
Retention samples may be taken for TGA Laboratory testing.
-----

My problem is with the sentence "Audit is conducted." I find nothing in those three words that begins to answer the question "How does Brauer do quality testing to make sure that the pills have, for example, Coffea 30C and not Coffea 29C?"

Would you please clarify this for me?
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Well done, Juryone. But this guy still won't answer any specific questions - like a politician really. Ignore the question and say what you want to say. Interesting to see how he responds to your post.
 
I see there is a response now to Juryone's post. Not from the usual guy. He has in fact provided a straight answer:

At the level of dilution of the coffee bean tincture in both Coffea 29C and Coffea 30C it is not possible to determine the difference by analytical means.
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So they are saying that they can only rely on their quality assurance system to assure that the product is what they say it is. Kind of like concrete I guess - you can't test for example, a whole bridge for compliance, you must carry out tests throughout the concrete manufacturing and construction process to assure the quality.

They most probably only have a QA system because it is a TGA requirement. But really the system is probably a bunch of ticks or crosses on a procedural checklist.

It would be interesting to see the system, given all of the manufacturing steps involved.

At least we have one question answered, so far.
 
Yes, I did get a reply to my post. Here's the full reply, edited to add paragraph breaks (what is it with that site editing out breaks?):

At the level of dilution of the coffee bean tincture in both Coffea 29C and Coffea 30C it is not possible to determine the difference by analytical means.

The Labelling Order (TGO 69) includes definitions for homoepathic preparation and homoeopathic potency. As the Order states, the serial dilution and succussion of the coffee tincture is the essential process in the manufacture of the homoeopathic ingredient. The assurance that the pills contain Coffea 30C and not Coffea 29C is obtained from the documentation of this process. Each serial dilution step and intermediate homoeopathic succussion is recorded to confirm that the dilutions and succussions have been carried out. Therefore the Coffea 30C homoeopathic ingredient of the pills can be traced back through all the 30 dilution steps to the mother tincture (extract of the coffee bean).

The inspection of such documentation is an important part of the conduct of a TGA inspection. In accordance with the Australian Code of Good Manufacturing Practice for Medicinal Products, an inspection typically commences with a physical examination of the premises and equipment and the flow of processes from raw materials receival and storage to finished product release for suppy. Detailed perusal of documentation such as standard operating procedures, batch records, specifications, test records and laboratory procedures forms a major part of a TGA audit.

Thus the quality of homoeopathic ingredients and finished products is the outcome of all these requirements of GMP, not just any applicable analytical or other testing at the end of the many processes and factors involved in the manufacture of these or other medicinal products.

Hoping that this has helped to clarity the points you raised,
Regards,
Allan Snook, Brauer Natural Medicine.
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Here is my response:

Thank you for your detailed response. It does, in fact, clarify that the audit is against the documentation of the procedure, not the finished product.

I do have a follow-up question related to your reply. In your reply, you state that there is "[d]etailed perusal of [...] test records". Given that "is not possible to determine the difference [between 29C and 30C dilutions] by analytical means", can you give me a broad idea on what kind of testing is done to validate batches of 30C homeopathic preparations?
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So the audit is done against documetation. Good thing we can trust them to not falsify documents.
 
A couple of people have made very long quotes from the other forum. Are these quotes copyright? Is it against this forum's rules to do the long quotes?

Anyway it is late and I am going to bed. Will brush my teeth using a 0C homoeopathic solution of toothpaste.
 
Part of the response to the above thread is as follows:

Since the 30C homoeopathic potency at the end of the serial dilution process consists, at least for analyatical purposes, entirely of the diluent that has been used in that process, the actual testing of the homoeopathic ingredient is necessarily limited to the quality of that diluent.
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The rest may be found at http://www.brauer.com.au/forum.asp under "Good Manufacturing Process".

So the quality of the remedy is determined entirely by the alcohol, sugar or water in which the mother tincture is dissolved. Well, he is being entirely honest. Since I am getting frank replies from him (unlike the MAS collective) I do not feel as though I should turn around and try to bash him over the head with the fact that he is saying the remedy consists entirely of the diluent. It's enough for me that he's admitted that fact.

I really could not care less about any theories he's got regarding the "vibrations" that remain at the end of 30C dilution. If anyone else cares to take it farther, feel free.
 
Well, he says that the diluents have been tested, he doesn't say who has tested it. I'd like to find out more about this test procedure - given the huge amounts of water that are used, what is the sampling frequency, how do they obtain representative samples, traceability, etc.

And he says that the mother tincture is able to be tested for compliance - not is tested.

They must have massive amounts of QA paperwork to deal with given all of manufacturing steps!

Perhaps his response should be summarised/clarified for the benefit of other readers of their forum?
 
Good heavens! Maybe they were going to do that anyway, but it is strange that just at the questions are asked........
 
Dang! I was holding off my next post.

At least we have some of the text saved here for prosperity.
 
rjh01 said:
A couple of people have made very long quotes from the other forum. Are these quotes copyright? Is it against this forum's rules to do the long quotes?
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rjh01 said:
People from here have been banned from certain forums for doing what comes naturally to them, ie asking sensible questions. However this is the first time I know that a forum has closed because of what we have done



Source http://www.brauer.com.au/forum.asp

Our fun is over.
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I think you've partially answered your own question as to why some of us do the long quotes.

I go to bed and wake up to find I've been a part of accomplishing something. I didn't have any idea that simple questions would make them shut down entirely. :blush:
 
Rustle said:
Do they have stockholders? You'd think that turning down $1M in profit would be something they would want explained...
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But they can't get the $1M - they've admitted it. Randi's standard test for homeopaths is for them to be able to tell the difference between a 30C remedy and the stock solvent. Brauer has admitted there is no analytical way of doing that. Randi is not wanting to get into a properly double-blinded medical test, given the cost and potential liability from such a test. Randi just wants them to be able to identify their cure, and they say they can't. Impasse.
 
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