This standard provides guidance regarding Good Manufacturing Practices for cosmetics products and has been prepared for consideration by the cosmetic industry.

Todays Tip:

Sampling – when preparing sampling plans for raw materials/packaging/bulk or finished product, don’t randomly allocate qty but use recognised standards (such as ISO 2859) to determine your sample size. In addition, the sampling plan should be commensurate with risk. If product A is low risk then sampling should be lower than product B which is high risk. If a standard is not used, statistics can also be used to determine a sample size. You don’t want to be spending too much time and money on a low risk component, focus on the components that pose a higher patient/consumer risk if there’s a failure within the process.

Specifications should exist for all materials. The specs should indicate the sample size, sample location, frequency, test method, acceptance criteria etc. If analytical test methods are developed in house, these should be validated. Otherwise, use compendial/recognised methods such as USP/BP methods. This will 1)satisfy the regulators and 2) ensure that the test method is accuare, robust, stable and precise.

For further information contact Compliance Management Solutions.

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA(medicinal products and medical devices) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification.