Samples are retained to fulfil two purposes; Reference sample A sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from critical intermediate stages or intermediates,…
Microbiological water analysis estimates the number of bacteria present and identifies microorganisms. The microbial population in a water sample can change over time, which can lead to inaccurate assessments of water quality. Therefore, it is recommended that water samples be transported and analyzed within six hours. It is dependent on your validation research of…
1. Random Sampling This method involves selecting samples randomly from a batch or lot. It is widely used for various pharmaceutical products. – Guidelines: ISO 2859-1:1999 (Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection). 2. Stratified Sampling In this method, the batch…
