HealthyValue™ products are produced by ANF, Inc., a private label manufacturer that has been in operation since 1989. ANF has produced several hundred million tablets, caplets, hard capsules, and softgel capsules for its mass-market customers during that time.
The safety, quality, potency, effectiveness, and – ultimately – the value of our products are guaranteed by a rigorous program of quality assurance that includes:
US dietary supplement industry and FDA-defined Good Manufacturing Practices (GMPs), based on well-defined Standard Operating Procedures (SOPs) that cover every step in the supply chain, from raw material production, to importation, to testing, to bulk purchase and delivery, to quarantine and release, to formulation, blending, to tableting, to bottling, labeling and packaging, to additional testing (if needed), to storage and shipment, to order-processing, fulfillment, and final delivery to the consumer.
Our supply chain is controlled at all times by an exact sequence of well-specified and documented steps. In greater detail, these are:
1) Compliance with County, State, & FDA Regulations: The
identity and permissibility of use of specific ingredients in human dietary
supplements in the United States, is, in fact legally defined and properly
regulated by the US Food and Drug Administration. ANF, Inc. conforms to these
regulations. The manufacturing facilities we use are regularly inspected and
certified by county health, state, and FDA inspectors.
2) Supplier Specifications: The identity, botanical name and/or chemical structure, origin, physical description, relevant food-grade safety standards, and minimum level of claimed active ingredient in every type of raw material supplied by each qualified supplier is specified and documented in detail, prior to purchase and delivery.
3) Certificates of Analysis: Certificates of
Analysis for each lot of ingredient raw material purchased and used in each
ANF production batch is provided by the supplier and keep on file by ANF, Inc.
4) Lab Test Verification: Test results from a qualified, independent testing laboratory must verify in a certified report the identity, safety, and potency of the Certificate of Analysis (CofA) linked to the sampling of each lot of raw material provided directly to the test lab by the supplier on behalf of ANF, Inc. and kept on file by all parties.
5) Quarantine and Release: Each lot of raw material
is kept in quarantine at the manufacturing facility until CofA’s and
lab results verify that they are qualified for release and use in manufacturing.
6) SOPs, GMPs, and Production Manuals: The exact
standard operating procedures (SOPs) for the preparation, use, and clean up
of the equipment and production room, the apparel and activities of the operators,
measurement of ingredients, including excipients and binders, mixing sequence,
blending times, tableting process, bulk tablet inspection, bottle filling,
sealing, bottle labeling, final packaging and outer labeling, and final inspection,
storage, and shipment are all specified in detail in production manuals, strictly
according to dietary supplement industry and FDA-reviewed good manufacturing
practices (GMPs).
7) Batch Records, Lot Numbers, Bottle Codes and Retained
Samples: Each manufactured batch of product is assigned a unique
production lot number. The batch records are filed and cross-referenced with
retained samples of the product from each lot for future reference. Labels
on each bottle of finished product are over-printed with expiration dates
and/or bottle codes that are recorded under each production lot number for
exact tracking.
8) Additional Testing Matching Retained Samples: Any additional testing that may be required is again done by a qualified independent lab, using specified methods and standards, on the same samples of the production lot from which retained samples are drawn and stored at the manufacturing facility. If needed, these additional test results must verify that all additional required final product specifications and standards are confirmed before the production lot can be released to the order fulfillment facilities for sale to the consumer. Retained samples are kept in storage beyond the expiration date on the bottle label.
9) Storage, Fulfillment, and Delivery: Finished
goods inventory is tracked to initial warehouse storage and then tracked as
shipments of sub-lots to order fulfillment facilities according to their original
lot number. The order numbers for each customer are recorded in the retail
sales database and cross-referenced with the bottle code and/or expiration
date, which is, in turn, cross-referenced to the production lot number from
which the finished product originated. The manufacturing and customer databases
cross-referencing this combined information is kept for several years beyond
the expiration date on the bottle.
This is only a brief overview of the HealthyValue™- ANF, Inc. Quality Assurance Program. Like the science used to formulate our products, the process of quality assurance is always evolving and improving. It is a critical part of guaranteeing your health and the health of our business. They are one and the same.
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