EU GMP Annex 19 - Reference and Retention Samples

What it says

Reference samples of starting materials and retention samples of each batch of finished product must be kept for defined periods, distinguishing reference samples, kept to permit analytical testing, from retention samples, kept to permit examination of the finished product's appearance, with specific retention periods and quantities defined.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Annex 19 draws an explicit distinction between reference samples, intended to support future analytical testing, and retention samples, intended to support visual and physical examination, a distinction not made as explicitly in the equivalent US provision.
• Retention periods and required quantities are specifically defined and scale with factors such as batch size and product type, requiring a documented, product-specific retention plan rather than a single uniform approach.
• This annex applies to both starting materials and finished product, requiring two distinct but related retention programmes operating under the same overall framework.

What inspectors look for

• Whether reference and retention samples are correctly distinguished and stored under conditions appropriate to their respective purposes.
• Whether retained quantities are genuinely sufficient to support the analytical testing or examination the samples are meant to enable, if ever needed.
• Whether retention periods are tracked accurately per batch, with samples not disposed of before their required retention period has elapsed.

Related regulations