Tuesday, September 15, 2015

The Four Pillars of a Quality Monitoring System

VITAMIN CONSULTANCY UPDATE eMEMO15 September 2015

Memorandum from Ralph Fucetola JD

To: Vitamin Consultancy Contact List:

Excerpts from The Four Pillars of ICH Q10

International Conference on Harmonization
(ICH) Q10 model describes the elements of an effective
Quality Management System (QMS). 

1. Process Performance and Product Quality Monitoring System

ICH Q10 states that in order to ensure a maintained state of control, companies should plan and execute a system for the monitoring of process performance and product quality. The process performance and product quality monitoring system should, for example, use quality risk management in order to establish a control strategy. These controls must encourage an effective CAPA.

2. Corrective and Preventive Action (CAPA) System

ICH Q10 states that there should be a system in place to launch a CAPA stemming from complaints, rejection of products, nonconformance, audits, as well as trends from process performance and product quality monitoring.

3. Change Management System

Change is necessary to ensure continual improvement in the product lifecycle. ICH Q10 states that in order to properly evaluate, approve, and implement changes, an organization must have a Change Management system in place.

4. Management Review of Process Performance and Product Quality

Management reviews are necessary to provide assurance that process performance and product quality are efficiently managed throughout the lifecycle and that quality and compliance are being met across the organization. 

 A critical component to any quality system is creating visibility of the key challenges facing the organization to management. This should be conveyed in an effective manner and timely communication and escalation process to ensure that senior management is aware of quality issues that must be reviewed.


Conclusion


ICH Q10 strives to set forth the guidelines for an effective Quality Management System.

These notes summarize the major elements of ICH Q10 and identify the specific points in which the QMS’s tools come in. 

We discussed the four pillars of ICH Q10: [1] Process and Product Monitoring System, [2] CAPA, [3] Change Management System, and [4] Management Review.

The VitaminConsultancy.com's SOP Formats include the elements of the Four Pillars.


For health and freedom,

Ralph Fucetola JD

PS: I'd like to thank the Trustees of the Institute for Health Research for appointing me President of the Institute, founded in 1998. Its web site is: www.InHeRe.org.

Tuesday, June 16, 2015

Personal Importation / Antioxidant Claims / Cosmetic Dossiers...

VITAMIN CONSULTANCY UPDATE eMEMO
June 16, 2015


Memorandum from Ralph Fucetola JD

To: Vitamin Consultancy Contact List: Personal Importation  / Antioxidant Claims / Cosmetic Dossiers...

But first: With Rima Laibow MD, Jim Turner JD and Larry Becraft JD's help I just filed a formal Petition with FDA regarding Informed Consent. Read and support here:

http://tinyurl.com/InformedConsentPetition

[1] Personal Importation... wrote about that years ago here: http://www.lifespirit.org/perimport.html

Recently prepared a Certification Format for personal importation. That format is at the bottom of this email.

[2] Many vitamin purveyors want to make Antioxidant Claims about their products. Free-radical quenching nutrients are of great significance in achieving and maintaining a healthy status...

So it shouldn't surprise us that FDA has restrictive regulations on using the term "Antioxidant" -- restrictions of which very few in the industry are aware.

Here is the central relevant regulation language [there are other requirements which I can discuss with you if you are interested]:

"(g) Nutrient content claims using the term "antioxidant." A nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label or in the labeling of that food when: (1) An RDI has been established for each of the nutrients; (2) The nutrients that are the subject of the claim have recognized antioxidant activity; that is, when there exists scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions..."

Primarily, the restriction that often causes issues for herbal antioxidants and other nutrients is that they do not have a RDI -- Recommended Daily Intake -- and thus cannot qualify under the Regulation. So what is the work-around?

Since the Vitamin Consultancy is here to make sure you have a way around bureaucratic restrictions, this is my suggestion for an alternative rubric to express your products' antioxidant claims if they do not qualify under the Regulation:

"Supports Normal Antioxidant Function" -- SNAF.

Of course, "the devil is in the details" and I'm here to work with you on those. Valid substantiation is required. Just let me know how I can help.

[3] If you are on this elist, you are most likely involved in the Natural Products market. And, if so, a number of you have, in addition to dietary supplement products, some cosmetic products.

And... if so... have you considered marketing your natural cosmetic products in the European Union? The EU Cosmetic Dossier requirements are similar to the FDA's Section 740 safety dossier requirements.

These are special rules that easily let you do just that!

Rima Laibow, MD and Robert Goodman, PhD have teamed-up with me to provide the required third-party Cosmetic Dossier services for you.

What is that?

Take a look at the short slide presentation here:

http://vitaminconsultancycertification.weebly.com/eu-cosmetic-dossiers.html

You will be pleasantly surprised.

[3] And remember that my full SOP Training Webinar System is available for your use: www.SOPcertification.com. Does your manufacturing facility need a Virtual Audit? More about that here: www.RegulatoryComplianceNetwork.com.


If you need me, you know how to reach me... 973.300.4594

Regards,

Ralph

Petition for Regulatory Discretion
Certification of Personal Importation Pursuant to
FDA RPM Ch. 9-71, Coverage of Personal Importation

[Name], [Address], [Phone], [eMail], as though sworn under Oath, states:

1.     I am a resident of [State] and a United States citizen.
2.     I was diagnosed by [Name], MD with [Medical Condition], Stage [#]. My treating physician is [Name], MD.
3.     I have researched my options and have made the Informed Consent decision to engage in a course of therapy with [Name], a remedy not available in the United States.
4.     I have personally ordered a 90 day supply of same for my personal use.
5.     The remedy is intended for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means, and it is not considered to represent an unreasonable risk.
6.     I am a person who has made my own arrangements for obtaining an unapproved drug from foreign sources.
7.     To the best of my knowledge this remedy has not been commercially promoted in the United States.
8.     I therefore request that FDA exercise discretion and permit this personal importation, Order No. ________________________.

I certify that the above statements made by me are true to the best of my knowledge and belief. I am aware I am subject to punishment as for perjury if any are willfully false.

[Date]

                                                                   ___________________________
                                                                   [Name]

[The Certification to be included by the Shipper in the shipment.]
Prepared by: Ralph Fucetola JD - www.vitaminconsultancy.com

Friday, April 24, 2015

Antioxidant Claims and FDA Regulation

VITAMIN CONSULTANCY UPDATE eMEMOApril 21, 2015
Memorandum from Ralph Fucetola JD
To: Vitamin Consultancy Contact List:
Keep May 1, 2015 open for an exciting Health Freedom Event: the Mayday! Marathon :  http://tinyurl.com/MaydayMarathon.
[1] Many vitamin purveyors want to make Antioxidant Claims about their products. Free-radical quenching nutrients are of great significance in achieving and maintaining a healthy status...
So it shouldn't surprise us that FDA has restrictive regulations on using the term "Antioxidant" -- restrictions of which very few in the industry are aware.
Here is the central relevant regulation language [there are other requirements which I can discuss with you if you are interested]:
"(g) Nutrient content claims using the term "antioxidant." A nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label or in the labeling of that food when: (1) An RDI has been established for each of the nutrients; (2) The nutrients that are the subject of the claim have recognized antioxidant activity; that is, when there exists scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions..."
Primarily, the restriction that often causes issues for herbal antioxidants and other nutrients is that they do not have a RDI -- Recommended Daily Intake -- and thus cannot qualify under the Regulation. So what is the work-around?
Since the Vitamin Consultancy is here to make sure you have a way around bureaucratic restrictions, this is my suggestion for an alternative rubric to express your products' antioxidant claims if they do not qualify under the Regulation:
"Supports Normal Antioxidant Function" -- SNAF.
Of course, "the devil is in the details" and I'm here to work with you on those. Valid substantiation is required. Just let me know how I can help.
[2]  If you are on this elist, you are most likely involved in the Natural Products market. And, if so, a number of you have, in addition to dietary supplement products, some cosmetic products.
And... if so... have you considered marketing your natural cosmetic products in the European Union?
There are special rules that easily  let you do just that!
Rima Laibow, MD and Robert Goodman, PhD have teamed-up with me to provide the required third-party EU Cosmetic Dossier services for you.
What is that?
Take a look at the short slide presentation here:
You will be pleasantly surprised.
[3] And remember that my full SOP Training Webinar System is available for your use:www.SOPcertification.com . Does your manunfacturing facility need a Virtual Audit? More about that here:  www.RegulatoryComplianceNetwork.com.

Thursday, February 12, 2015

Introducing the Vitamin Consultancy eMemo Archives

Introduction to the Archives

Since November of 2007 clients and others "following" the Vitamin Consultancy have received over 145 special Vitamin Consultancy Update eMemos. The memos have covered many issues of interest to dietary supplement and natural product purveyors, Advanced Health Care ("CAM") practitioners, researchers, journalists and other interested persons.

This Blog serves as the Archives for the Update eMemo. Here you can search the data through the "Tags" or Labels we've added to the posted memos.

Key web sites for more information include:

Original Vitamin Lawyer Web Site:
http://www.vitaminlawyer.com

New Site: www.VitaminConsultancy.com

SOP Certification Program:
http://www.vitaminindustrycompliance.com


Counsel Ralph and Dr. Ed Group:
http://www.youtube.com/watch?v=SWDLDEldnVw



And my social media sites:

http://twitter.com/HealthFreedomUS

https://www.facebook.com/pages/Financial-Restructuring-Services/438062246286333

https://www.facebook.com/GeneralArbitrationSubmission

https://www.facebook.com/RegulatoryComplianceNetwork

https://www.facebook.com/VitaminLawyerConsultancy

https://www.facebook.com/pages/Natural-Clinical-Trials-Network/205864456133878

http://www.NaturalHealthOptions.net

And these third party links are important to protect all our access to supplements and natural remedies:

The Health Keepers Oath: http://www.HealthKeepersOath.org

Be a Vaccine Refuser with Me: http://tinyurl.com/VaccineRefuser

Health Freedom: http://GlobalHealthFreedom.org

-----------------------------------------------
Counsel Ralph Teaching At the Global healing Center, Houston

Ralph Fucetola JD received a B.A. with Distinction from Rutgers University, 1967 and a Juris Doctor (Doctorate in Law) from Rutgers Law School, 1971.

Since then he has been active in the business and public service communities and practiced law (from 1971 through 2006) specializing in the Nutrient and Alternative Health fields. He is a New Jersey Notary, #2398815.

Counsel Fucetola has been widely recognized as a leading attorney in the field, receiving numerous awards, including a Citation of Merit from the National Health Federation in 1979 and a Meritorious Service Award (from the Institute for Health Research, www.inhere.org) for his role in the 1995 DHEA Cases on behalf of the Life Extension Foundation.

Counsel Fucetola limits his consultancy practice to claims, advertising and label review, asset protection, and consulting with marketers, consumers, advocates and local attorneys regarding Health Care Freedom issues, petitions and litigation. He offers Standard Operating Procedures certification training programs for dietary supplement and natural product companies, advanced health care practitioners who have their own "private label" products and minister practitioners.

He has varied business background experience, including direct management responsibility with companies in the following fields: Real Estate Management; Construction; Dietary Supplement Products and Alternative Modality Products. He is Counsel to and a trustee of Natural Solutions Foundation, www.globalhealthfreedom.org.

Disclaimers, Disclosure and Webinars


Memorandum from Ralph Fucetola JD

Date: January 8, 2015
To: Vitamin Consultancy Contact List:

CERTIFICATION COURSE PRICES REDUCED!


[1] I'll be on Gary Franchi's news program today, 5 PM Eastern:

[2] UPDATED 2014 VITAMIN DISCLOSURES AND DISCLAIMERS
Here is a link to my list of updated Dietary Supplement Disclosures and Disclaimers that purveyors may want to consider for their labels and advertising: 

[3] FDA GOT YOUR TONGUE? WE CAN FIX THAT!
[4] CBD Update! We got our Permit! Call me now to invest: 973.300.4594
You can also donate to support the product (discount rewards) here: