An important part of Quality Management in the Pharmaceutical Industry is derived from a process known as Sampling, which allows for the approval of products without individual testing. Nevertheless, as an operation in which only a small fraction of a batch is taken, Sampling can only produce valid conclusions if based on tests that have been carried out on representative samples. This is why correct sampling is so essential to a Quality System. Read more about this process below and discover how RC Redol can help you navigate through it.
The first important aspect of Sampling is that it has a high degree of human participation. Hence, personnel responsible for taking samples should receive both regular initial training, as well as ongoing training during the process, in the disciplines relevant to perform correct sampling. In this regard, some areas for this training are vital to carry out this process, namely those described in the list below:
- sampling plans
- written sampling procedures
- the techniques and equipment for sampling
- the risks of cross-contamination
- the precautions to be taken regarding unstable and/or sterile substances
- the importance of considering the visual appearance of materials, containers, and labels
- the importance of recording any unexpected or unusual circumstances
Process-wise, it is crucial that the samples are representative all along the process, and the number of samples taken should be determined statistically and specified in a sampling plan. For example, the quality of a batch of starting materials may be assessed by taking and testing a representative sample, for example by using the samples taken for identity testing for this purpose. Also, the number of individual samples that may be blended to form a composite sample should also be defined, considering the nature of the material, knowledge of the supplier, and the homogeneity of the composite sample.
Regarding packaging materials, the number of samples taken should also be determined statistically and follow a sampling plan. Furthermore, the sampling plan should take into account of at least the following: the quantity received, the quality required, the nature of the material (e.g. primary packaging materials and/or printed packaging materials), the production methods, and what is known of the Quality system of the packaging materials manufacturer based on audits.
Finally, it is good to remember that it is possible to ensure a correct way to perform Sampling, by ways of an elaborate and concrete SOP, which will, in turn, help to avoid sanctions by the authorities. RC Redol can be your partner in this journey, as a specialized consultant and as a source of proper training, as we can provide the know-how and experience necessary for your organization to keep up to date with the regulations and to ensure correct quality management. Contact us today to discover how!
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