cGMP CERTIFCATE

 

cGMP CERTIFCATE

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.

It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

Why are CGMPs so important?

A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMPs require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.

Food and Drug Administration (FDA)


Food and Drug Administration (FDA)

The inspection conducted by FDA will examine your production process, look at certain records and collect samples. At the conclusion of the inspection, the investigator will discuss with your firm's management any significant findings and concerns; and leave with your management a written report of any conditions or practices, which, in the investigator’s judgment, indicate objectionable conditions, or practices.

Halal Certificate


Halal Certificate

Halal is an Arabic word that means permissible. A Halal certified product means that the product is permissible or acceptable in accordance with Islamic law. In order for products to receive this certification, , they must be from an acceptable source such as a cow or chicken and slaughtered according to these laws.

Offering Halal certified products allows Muslim consumers to be confident that the products they use are in alignment with their culture and beliefs.

Kosher Certificate


Kosher Certificate

In Hebrew, “kosher” means fit. Kosher food is any food fit for consumption by Jewish people.

The laws of kosher define which foods a person can and cannot eat, and also how they should produce and handle certain foods. The laws also state which combinations of foods that people should avoid.

USDA Organic


USDA Organic

Organic is a labeling term found on products that have been produced using cultural, biological, and mechanical practices that support the cycling of on-farm resources, promote ecological balance, and conserve biodiversity.

In order to make an organic claim or use the USDA Organic Seal, the final product must follow strict production, handling and labeling standards and go through the organic certification process.  The standards address a variety of factors such as soil quality, animal raising practices, and pest and weed control.  Synthetic fertilizers, sewage sludge, irradiation, and genetic engineering may not be used.

Vegan Certificate


Vegan Certificate

Distributed and recognized globally, the Certified Vegan Logo is a registered trademark, similar in nature to the kosher mark, for products that do not contain animal products or byproducts and that have not been tested on animals. The certified logo is easily visible to consumers interested in vegan products and helps vegans to shop without constantly consulting ingredient lists. It also helps companies recognize a growing vegan market, as well as bringing the word Vegan—and the lifestyle it represents—into the mainstream.

Canadian Food Inspection Agency


Canadian Food Inspection Agency

The Canadian Food Inspection Agency is dedicated to safeguarding food, animals and plants, which enhances the health and well-being of Canada's people, environment and economy. 

HACCP management system


HACCP management system

HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

Natural Product Number


Natural Product Number

Natural Product Number (NPN) is an eight (8) digit numerical code assigned to each natural health product approved to be marketed under the Natural Health Products Regulations.

All natural health products (NHPs) sold in Canada require a product licence before being marketed. The product licence number on the label assures consumers that the product has been reviewed and approved by Health Canada for safety and efficacy. ...

All our products have NPN numbers.

SQF


SQF

SQF certification is based on government and industry food safety requirements, so businesses at every level have the ready documentation they need to demonstrate the steps they’ve taken to increase food safety.

Obtaining SQF certification isn’t just about protecting consumers, food service providers and retailers. It’s also about protecting the producers themselves. SQF certification not only gives growers assurances that the food they’re selling has been produced to the highest possible standards, it also puts their contact information in an instantly accessible database that retail and foodservice buyers around the world can look to for suppliers they can trust.