Tag Archives: GMP

FDA Registered Organic Sulfur

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fdaOrganic Sulfur OS comes from an FDA registered facility in the United States. What is an FDA registered facility and why is this important ?  Organic Sulfur is recognized as an unexpirable  food by both the Canadian and American Customs services. It is not a drug. As part of the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 also known as the Bioterrorism Act the Food and Drug Administration ( FDA) , as the food regulatory agency of the Department of Health and Human Services , to take steps to protect the public from threatened or actual terrorist attacks on the US food supply and other food related emergencies. Registration means our product has met the highest quality controls available. These are done at a modern state of the art facility and not a third party entity.
Preventive duties of the FDA include:

  • Mandatory preventive controls for food facilities
Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise.
  • Mandatory produce safety standards
FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water.
  • Authority to prevent intentional contamination
FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.
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Organic Sulfur OS with GMP approval

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GMPOrganic Sulfur OS is proud to bring  a certified  GMP product to our customers.  What is the GMP seal of approval ? Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food products in our case. These guidelines provide minimum requirements that a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. Good manufacturing practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries. As a Product of USA , the GMPs  of Organic Sulfur OS are enforced by the U.S. Food and Drug Administration (FDA).

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a drug product is safe for human consumption.

Basic GMP principles are as followed

  • Hygiene: Food manufacturing facility must maintain a clean and hygienic manufacturing area.
  • Controlled environmental conditions in order to prevent cross contamination of one product from other or extraneous particulate matter which may render the 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 product are validated as necessary.
  • Instructions and procedures are written in clear and unambiguous language.
  • 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 product 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.
  • A system is available for recalling any batch of  product from sale or supply

 

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