(2003; 148 pages)
Control of starting materials and intermediate, bulk and finished products
17.7 All tests should follow the instructions given in the relevant written test procedure for each material or product. The result should be checked by the supervisor before the material or product is released or rejected.
17.8 Samples should be representative of the batches of material from which they are taken in accordance with the approved written procedure.
17.9 Sampling should be carried out so as to avoid contamination or other adverse effects on quality. The containers that have been sampled should be marked accordingly and carefully resealed after sampling.
17.10 Care should be taken during sampling to guard against contamination or mix-up of, or by, the material being sampled. All sampling equipment that comes into contact with the material should be clean. Some particularly hazardous or potent materials may require special precautions.
17.11 Sampling equipment should be cleaned and, if necessary, sterilized before and after each use and stored separately from other laboratory equipment.
17.12 Each sample container should bear a label indicating:
(a) the name of the sampled material;
(b) the batch or lot number;
(c) the number of the container from which the sample has been taken;
(d) the number of the sample;
(e) the signature of the person who has taken the sample;
(f) the date of sampling.
17.13 Out-of-specification results obtained during testing of materials or products should be investigated in accordance with an approved procedure. Records should be maintained.