EUGMP 附录19 对照样品和留样（英文版）

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EUROPEAN

COMMISSION

Brussels, 23.6.2026

C(2026) 4135 final

GUIDELINES

The Rules Governing Medicinal Products in the European Union

Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for

Human and Veterinary Use

The Rules Governing Medicinal Products in the European Union

Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for

Human and Veterinary Use

Annex 19

Reference and Retention Samples

Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the

Community code relating to medicinal products for human use. This document provides guidance

for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for

medicinal products as laid down in as laid down in Commission Directive 2017/1572/EU for

medicinal products for human use.

Status of the document: Revision of the 2006 version of Annex 19.

Reasons for changes: The GMP/GDP Inspectors Working Group and the PIC/S Committee

jointly recommend that the current version of annex 19, on the Reference and Retention Samples,

is revised with respect to reference and retention Samples for Parallel Imported/Parallel

Distributed/Parallel Traded Products.

Deadline for coming into operation: 3 months from the date of publication by the European

Commission.

Scope

1.1

This Annex to the Guide to Good Manufacturing Practice for Medicinal Products (“the

GMP Guide”) gives guidance on the taking and holding of reference samples of starting

materials, packaging materials or finished products and retention samples of finished products.

1.2

Specific requirements for investigational medicinal products are given in Detailed

Commission guideline on GMP for investigational medicinal products.

1.3

This annex also includes guidance on the taking of retention samples for parallel

imported/ distributed medicinal products.

Principle

2.1

Samples are retained to fulfil two purposes, firstly to provide a sample for analytical

testing and secondly to provide a specimen of the fully finished product. Samples may therefore

fall into two categories:

Reference sample: a sample of a batch of starting material, packaging material or finished

product which is stored for the purpose of being analysed should the need arise during the shelf

life of the batch concerned. Where stability permits, reference samples from critical

intermediate stages (e.g. those requiring analytical testing and release) or intermediates, that

are transported outside of the manufacturer’s control, should be kept.

Retention sample: a sample of a fully packaged unit from a batch of finished product. It is

stored for identification purposes. For example, presentation, packaging, labelling, patient

information leaflet, batch number, expiry date should the need arise during the shelf life of the

batch concerned. There may be exceptional circumstances where this requirement can be met

without retention of duplicate samples e.g. where small amounts of a batch are packaged for

different markets or in the production of very expensive medicinal products.

For finished products, in many instances the reference and retention samples will be presented

identically, i.e. as fully packaged units. In such circumstances, reference and retention samples

may be regarded as interchangeable.

2.2

It is necessary for the manufacturer, importer or site of batch release, as specified under

section 7 and 8, to keep reference and/or retention samples from each batch of finished product

and, for the manufacturer to keep a reference sample from a batch of starting material (subject

to certain exceptions – see 3.2 below) and/or intermediate product. Each packaging site should

keep reference samples of each batch of primary and printed packaging materials. Availability

of printed materials as part of the reference and/or retention sample of the finished product can

be accepted.

2.3

The reference and/or retention samples serve as a record of the batch of finished product

or starting material and can be assessed in the event of, for example, a dosage form quality

complaint, a query relating to compliance with the marketing authorisation, a

labelling/packaging query or a pharmacovigilance report.

2.4

Records of traceability of samples should be maintained and be available for review by

competent authorities.

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