“Representative samples of each shipment of each lot shall be collected for testing or examination,” states FDA Article 211.84(b).
“The number of containers to be sampled shall be based on relevant criteria, including statistical criteria for component variability, confidence levels and degree of desired precision, and the historical quality history of the provider,” states the specification.
The sampling of beginning and packaging materials section of PIC/S cGMP annex 8 states that sampling is a crucial procedure in which only a tiny portion of a batch is taken. Tests conducted on non-representative samples are not sufficient to draw valid general conclusions. Hence, accurate sampling is a crucial component of a quality assurance system.
Why is sampling important in the pharmaceutical industry?
We’ve discussed sampling, which is the process of taking a representative sample from a batch to determine whether the product’s composition, attributes, and features are accurate.
Testing samples is done to draw conclusions about the population from which the sample was taken. The immediate advantages of sampling are:
To calculate the average quality level
– To identify a specific degree of faults
– To evaluate heterogeneity levels
– To detect contamination, labelling errors, or mix-ups
– To confirm the anticipated level of delivery quality
When sampling, we presume or accept that:
– Our conclusions have an acknowledged or implied inherent risk.
– The lot’s flaws are dispersed randomly.
– The manufacturing process is reliable and ongoing.
Important issues to consider during sampling
In conducting the sampling technique, you should pay particular attention to the following considerations.
– Use only clean sampling equipment.
– Maintain environmental control to avoid cross-contamination.
– Sampling must be repeatable; adhere to SOPs.
– The location of the sample should be specified, for example, top, centre, or bottom
Sample from a cross-section
– Internal samples should be used.
– The drum or container it came in.