Quality Control in Product Manufacture

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

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 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.