QUALITY CONTROL STANDARDS FOR

NEUTRACEUTICAL FORMULARIES

Neutraceutical Formularies is committed to having the highest quality standards in the industry. Some people think that a “non-drug” nutritional supplement doesn’t have the high quality controls and is not regulated by any agencies.

The truth is that all nutritional supplements must comply with FDA industry standards that have very specific controls for quality and potency. It is true that some companies don’t follow these standards strictly but NF not only follows all FDA standards but also higher standards of additional testing and high level affiliations with internationally recognized groups.

The commitment for NF enables you to have a greater assurance that these strong potency formularies deliver what they say with high quality purity.

All Neutraceutical Formularies products are lab tested at 3 levels of the formula & production process.

1. Every individual ingredient is tested by the grower at the time of shipment to our lab. An authenticated certificate of analysis must be provided by the grower or producer before the ingredient is accepted.

2. Once a formularie is blended, the powder mix is sent out for another round of testing to ensure potency to label claim, synergy of the nutrients and to check for any contaminants like e.coli, salmonella, heavy metals etc.

3. Then NF takes it a step further and this additional step is not done by most companies because of the additional costs but it is mandatory here at NF. After the formula is blended, capsulated, bottled and labeled, we send the finished formula to an independent lab for microbial contaminant and potency testing again. This ensures that the label claim strength has not been diminished through any step of the manufacturing process.

Here is a list of some of the Groups, Agencies and Companies that Neutraceutical Formularies ingredients have affiliations with.

FDA- The Food and Drug Administration

Under FDA regulations at 21 CFR part 111, all domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control.

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.

Good manufacturing practice guidelines provides guidance for manufacturing, testing, and quality assurance in order to ensure that drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturer must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Neutraceutical Formularies lists on each label the fact that each formula is manufactured ONLY in a GMP lab.

All guidelines follow a few basic principles:

• Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency 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.

Practices are recommended with the goals of safeguarding the health of patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the United States, a drug may be deemed "adulterated" even though it has passed all of the specifications tests and it is found to be manufactured in a facility or condition which violates or do not comply with current good manufacturing guideline. Therefore complying with GMP is a mandatory aspect in pharmaceutical manufacturing and Neutraceutical Formularies makes it mandatory that all of their formulas are manufactured this way even though they are not a pharmaceutical company.

The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Singapore, Philippines, Vietnam and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP

An intergovernmental organization, FAO has 194 Member Nations, two associate members and one member organization, the European Union. Its employees come from various cultural backgrounds and are experts in the multiple fields of activity FAO engages in. FAO’s staff capacity allows it to support improved governance inter alia, generate, develop and adapt existing tools and guidelines and provide targeted governance support as a resource to country and regional level FAO offices. Headquartered in Rome, Italy, FAO is present in over 130 countries. NF’s enzyme grower is affiliated with the FAO.

WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

JECFA is an international expert scientific committee that is administered jointly by the food and agriculture organization of the united nations (FAO) and the World Health Organization (WHO).

IFOAM is the worldwide umbrella organization for organic agriculture.

Over 40 Years Leading, Uniting and Assisting
the Worldwide Organic Movement.

Since 1972, IFOAM has occupied an unchallenged position as the only international umbrella organization of the organic world, i.e. all stakeholders contributing to the organic vision. This allows IFOAM to unite, lead and assist the organic movement - all IFOAM Affiliates - in its full diversity, while providing a common voice on relevant organic issues. IFOAM implements the will of its broad-based constituency, with Affiliates in more than 100 countries and is governed by a World Board originating from all continents. The IFOAM Action Network comprises self-organized IFOAM regional and sector groups and daughter organizations.