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PE009-13, the PIC/S guide to GMP for medicinal products

TGA interpretation and expectations for demonstrating compliance

2 January 2018

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Reference and retention samples (Annex 19)

A reference sample is a sample for the purpose of future analysis, which could refer to starting materials, packaging materials or finished products.

A retention sample is a sample representing the batch of finished product as distributed.

Samples from a stability trial program cannot be used as retention samples.

Multipack products and retention samples

Complete multipacks for products packaged this way do not necessarily need to be kept as retention samples. The requirement is that the amount of retention samples is sufficient to carry out analytical work during the entire shelf life of the product.

Book pagination