Different Sampling Strategies in Pharmaceutical Industry
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 is divided into subgroups or strata based on specific characteristics, and samples are taken from each subgroup.
Guidelines: ISO 3951-1:2005 (Sampling procedures for inspection by variables – Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection).
3. Composite Sampling
It involves combining multiple samples from different locations within a batch to create a representative composite sample.
Guidelines: USP General Chapter <905> (Uniformity of Dosage Units) and ISO 15194:2002 (Water quality – Guidance on the estimation of measurement uncertainty).
4. Incremental Sampling
This method is used for large quantities of bulk materials where samples are collected at regular intervals as the material is being discharged or transferred.
Guidelines: ASTM D6609-17 (Standard Guide for Part-Stream Sampling of Coal).
5. Grab Sampling
It involves quickly collecting a single sample from a specified location to capture the characteristics of the product at that particular moment.
Guidelines: ASTM D4057-19 (Standard Practice for Manual Sampling of Petroleum and Petroleum Products).
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