What is GMP?

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug AdministrationGMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs and some food take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.


The USA legislation requires the mandatory certification of the manufacturing facilities according to the GMP standards only from the pharmaceutical (drug) manufacturers. GMP certification for the production of dietary supplements is voluntary. This situation can be changed very soon.

The FDA suggested the implementation of a new law for the mandatory GMP certification for all USA manufacturing facilities producing dietary supplements. After the implementation of this law all manufacturing facilities will have to make adjustments to GMP standards, and pass the independent audit within three years in order to get GMP certification. Even in the best case scenario all American dietary supplement manufacturers will not be completely certified till 2009.

The big manufacturers who have already obtained the GMP certificates are approving this initiative, hoping that it will help to get rid of unscrupulous competitors producing low-quality output.

All Santegra's products are manufactured at one of the biggest USA facilities, with the complete GMP certification.

 

The list of the certificates includes:


- The GMP certificate issued by the National Nutritional Foods Association (NNFA). Annual inspection and certification according to GMP standards since 1994.
- GMP certificate issued by American National Public Health and Safety Agency (NSF) (GMP requirement in NSF/ANSI Standard 173, Section 8 - Dietary Supplements). Certificate was issued in 2003 for the first time and verified every year by the independent audit.
- GMP certificate issued by Therapeutic Goods Administration (TGA), the Australian Health Ministry designed to ensure public health and safety, approved by the World Health Organization (WHO) and Pharmaceutical Inspection Convention (PIC). Certificate was issued in 2002 for the first time and verified every two years by the independent audit.
- Certificate of compliance with the regulation of the European Parliament on the hygiene of foodstuff issued by TUV (the independent expert agency with the head office in Germany, recognized by European and World leaders as an independent expert). The certificate was issued in May, 2006.
At the present moment among thousand manufacturers of dietary supplements only few have the similar list of certificates.

Complying with the GMP regulations is work consuming and very expensive process. Every step of this process that starts with the purchase of raw materials, and ends with the packing of finished products undergoes the thorough screening.

The big advantage of all SantegraR's products is that they are created in strict compliance with GMP, unlike many other products in the dietary supplement market.

Only the leaders of this industry have the opportunity to finance additional expenses for the GMP certification to guarantee the highest quality of their products. This is the reason for a big price range of the dietary supplements from different manufacturers. Good quality products cannot be cheap, but you cannot put a price tag on your health.

The dietary supplement market offers a wide range of different products, but not all of them are healthy, as a matter fact it is impossible to verify the quality of a specific product by eye.

That is why it's important that all SantegraR's products are manufactured in strict compliance with GMP standards and regulations that guarantees perfect quality.


Truly Yours,
Santegra USA