Good Manufacturing Practices

Quality Supplements

The ruling requires that dietary supplements are manufactured consistently as to:

1) identity,

2) purity,

3) strength, and

4) composition.

These practices will ensure that you can expect to get the exact ingredients in the amount listed on the container.

Some dietary supplement companies have already implemented GMPs. Companies that do not comply with the GMPs will face criminal or civil penalties.

Facts from the U. S. Food and Drug Administration

Compliance for the final CGMPs is effective:

for large companies in June 2008

for companies with less than 500 employees in June 2009 and

for companies with fewer than 20 employees in June 2010

√ The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.

√ The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength and composition.

List of Practices

* Employ qualified employees and supervisors;

* Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labeling and holding;

* Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;

* Establish and use master manufacturing and batch production records;

* Establish procedures for quality control operations;

* Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected;

* Keep a written record of each product complaint related to CGMPs;

* Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.

Every dietary supplement company must have its own internal Quality Assurance department that is separate from production. Their job will be to ensure that whatever time is required will be taken to meet quality standards. Once certified, manufacturers are then allowed to use the GMP seal on their products.

If you are interested in a GMP certified macular degeneration vitamin company that offers vitamins that include those from the AREDS study and compares their vitamin formula to other companies click here:
Visivite - Macular Degeneration Vitamins

Benefits to the Consumer

1) meet quality standards and

2) are free from contamination and

3) are accurately labeled.

* The rule addresses the quality of manufacturing processes for dietary supplements and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements, or address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used.

GMPs will help clear away the the obstacle that the supplement industry is not regulated or its quality is inconsistent. Before you make your next macular degeneration antioxidant and vitamin purchase make sure the company is following Good Manufacturing Practices.

Go from Good Manufacturing Practices to Vitamins for Macular Degeneration

Conctact Leslie Degner, RN, BSN

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