Sampling of incoming materials
Article 32
1. Personnel in charge of taking samples shall receive training on the techniques and equipment for sampling, the risks of cross-contamination, precautions to be taken with regard to unstable or sterile substances, the need to record any unexpected or unusual circumstance as well as other aspects relevant to the implementation of the sampling procedures. 2. Samples shall be representative of the batch of material from which they are taken. The taking of samples shall be done in accordance with written procedures that describe at least the following: (a) the number of containers to be sampled; (b) which part of the container to sample; (c) the amount of sample to be taken from each container. 3. The number of containers to sample and the sample size shall be based upon a sampling plan that takes into consideration the following: (a) the criticality of the incoming material; (b) material variability; (c) compliance history of the supplier; (d) the amount of sample needed for analysis. 4. Sampling shall be conducted at defined locations and by procedures designed to prevent contamination of the material sampled and contamination of other materials. 5. Containers from which samples are collected shall be opened carefully and subsequently reclosed. They shall be marked to indicate that a sample has been taken. 6. Sample containers shall bear a label indicating the content, batch number, date of sampling and containers from which the samples have been taken.