Quality of pharmaceutical products majorly depends upon the sampling of the excipents and the active pharmaceutical ingredients. Proper sampling can give us confidence in our analysis. In other words we can say – sampling is a starting process but is has its importance.
WHO suggests 3 formulae of sampling for pharmaceutical ingredients in Technical Report Series TRS-929 - Annex 4, “WHO Guidelines for sampling of pharmaceutical products and related materials”
1. n-plan: This plan is used when the material is uniform and supplier is recognized and reliable. Sample can be taken from any part of the container. Samples are taken by using the formula n=1+√N. Sampling units are selected randomly and all containers shall be sampled if those are four or less in number.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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