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GMP is GOOD! Country Life is BETTER, GMP and Beyond!
Prior to the NNFA’s GMP Program, dietary supplements were regulated
as food products. The enforcement of these regulations was weak at
best. The NNFA GMP is the first comprehensive effort in setting stan-dards
for the Receipt, Testing, Manufacturing, Packaging, Holding and
Distribution of Dietary Supplements. GMP significantly increases the
level of product and process control.
Here are some examples of how Country Life exceeds the guidelines of
the GMP Program.
- Personnel
- People who are dedicated to your wellness.
- People who understand and respect the great trust that you place in
them to provide you with the finest products available.
Ingredients and Raw Materials
- Country Life uses only top quality, branded ingredients.
- Country Life performs multiple tests on raw materials exceeding the
minimum of one test as defined in the GMP’s.
- Careful selection of excipients to ensure product purity and integrity.
- Proprietary Aqueous Based Cellulose and Glycerin Tablet Coating.
Quality Control/Quality Assurance
Country Life has very detailed procedures and record keeping for all its
operations. These procedures define the how’s why’s when’s and
responsibilities for all critical operations throughout the plant. These
include Receiving, Quarantine, Testing, Release or Reject, all Processing
and Packaging Steps, Formulation Design and Change Control, Log Book
Utilization, Calibrations, Record Retention and Review, Analytical
Testing, Final Document Review and Release and traceability of
incoming and outgoing material.
- Packaging
- To extend & ensure our products freshness, we use recyclable amber
glass bottles that block out oxygen, light & moisture.
Equipment
- Stainless Steel or other materials accepted by the FDA and approved by
the USDA for product contact.
- V Blenders are used exclusively.
- Gravity feed of all blended ingredient mixes into tablet presses and fill-ing
equipment is utilized to ensure blend integrity, uniformity, and puri-ty.
This also limits the exposure of the product to the environment and
personnel.
- 24 hour manned video surveillance and security to ensure product
integrity.
- Plant Design
- State of the art Pharmaceutical Grade Air Handling and Integrated Dust
Collection Systems with temperature and humidity control. This means
that:
- Airflow patterns are designed to prevent any cross contamination of
products.
- Separate systems have been designed for Processing and Packaging.
- Airpasses through two banks of HEPA (High Efficiency Particle Air)
Filters. These filters have a minimum removal efficiency of 99.97%
0.3 microns, they are designed to remove particles, microbes,viruses,
and mold spores.
- Use of Purified Water U.S.P. which exceeds the U.S.E.P.A. potable
water requirements defined in the GMP’s for: suspended solids, total dis-solved
solids, chemical impurities, organics and microbials.
- Epoxy sealed walls and floors aid in the ease of cleaning and
sanitization and helps to inhibit the growth of bacteria and molds.
- Oil free compressed air with pharmaceutical filtration ensures that all
compressed air in contact with the product or product containers is free
of contaminants such as microbes and petrochemicals.
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