Source to Benefit Controls

Naturally variable

Natural health products, due to their natural sources, are inherently variable.

Why is it essential to have reproducible products?

To be a serious medicine, products need to be “essentially the same” from batch to batch. Why? If the product changes every batch, this means that the health benefits change too. Having consistently made products means that research on them using one batch are applicable to the product we buy today and tomorrow.

How are reproducible products made?

To achieve a reproducible product it is required to control this variability to the maximum extent possible. This is done by careful management and control of all of the inputs that lead to the variability, such as

• the genetics of the raw material
• how it is cultivated and harvested (if it is a medicinal plant)
• how it is processed to an active ingredient
• how it is made into a finished product
• how is is used and scientifically validated in humans

Supply Chain

Reproducible products are made when the supply chain is carefully controlled and monitored.

Quality Considerations

Raw Materials

Raw materials, especially herbal medicine raw materials, often undergo an extraction process before proceeding to manufacture of a finished product. Methods of extraction vary, with consequent variation in efficiency and the “phytochemical profile” of  any extract, even using the same starting materials. Of great significance is the solvent used in extraction, which can influence how much of a particular active constituent is present, because some plant chemicals are more soluble in water, while others are soluble in oils, ethanol and other organic solvents. Different solvents, yield different extracts. Extraction method and solvent determine the pharmacological characteristics of the product and it is possible to make entirely different medicines from the same plant just by choosing a different solvent.

Minimum Standards

A production facility certified to Good Manufacturing Practice (GMP).

Best Practices

Supply of raw materials

Best Practice demands more than the mandatory observation of Good Manufacturing Practice (GMP), as there is huge variability in the quality of the active ingredients too. Highest level Best Practice in certain countries in the world additionally require products to be made under Good Agricultural and Collection Practices (GACP) , which involve proper identification of the plant, documentation of all of the source to product process steps and Standard Operating Procedures that ensure consistent high standards and fail safe methods at every stage of the process to active ingredient manufacture.

Manufacture

Best Practice demands more than the mandatory observation of Good Manufacturing Practice (GMP). It requires Standard Operating Procedures that ensure consistent high standards and fail safe methods at every stage of finished product manufacture.

Indicators of activity and quality controls

Standardisation of all inputs and processes is essential to ensure product consistency (batch-to-batch consistency). It is achieved through a series of strict controls applied to manufacturing processes including solvents used and extraction methods, through to packaging, storage and transportation of finished goods.

Quality Control

Analytical procedures can be used in final quality control to ensure that essential constituents are present at the same levels shown effective and safe. A good example is Cranberry products, where studies have demonstrated that a minimum dose of 36mg of substances known as PACs (Proanthocyanidins) is essential in helping to reduce the incidence of recurrent urinary tract infections such as cystitis. If these PACs are not present in sufficient quantities then a cranberry extract will not be effective.