Chapter VII, Article 34 · Commission Implementing Regulation (EU) 2025/2091

Contents

Article 34Sampling#

1.A sampling plan shall be established, which shall take into account the risks to the quality of the veterinary medicinal product and address the different materials used in the manufacturing process as well as the various stages of production.

10.Where it is duly justified that a physical retention sample of the re-packaged finished product cannot reasonably be retained and it has been subject to prior authorisation by the competent authority, a photographic/digital sample of it may be retained.A photographic/digital sample of the re-packaged finished product shall:

(a)allow a full visual examination of the re-packaged product that is equivalent to that of a physical retention sample;

(b)include all data on both the immediate and outer packaging, including the batch number and expiry date;

(c)be stored in a computerised system that complies with all the requirements set out in Annex IV.

2.Samples shall be representative of the batch of materials or products from which they are taken. The sample taking shall be done in accordance with written procedures that describe at least the following:

(a)the amount of sample to be taken;

(b)equipment and containers to be used;

(c)precautions to be observed to prevent contamination;

(d)other precautions to be observed, in particular in the case of sterile or noxious materials;

(e)storage conditions for the samples taken;

(f)the cleaning instructions for the equipment used.

3.Personnel in charge of taking samples shall receive training on the following:

(a)techniques and equipment for sampling;

(b)the risks of cross-contamination;

(c)precautions to be taken with regard to unstable or sterile substances;

(d)the need to record any unexpected or unusual circumstance;

(e)other aspects relevant to the implementation of the sampling procedures.

4.Sample containers shall bear a label indicating the content, batch number, date of sampling and containers from which the samples have been taken. When containers are too small, the use of bar-codes or other means that permit access to that information may be considered.Sample containers shall be handled and stored in a way that minimises the risk of mix-up or the deterioration of their content. The storage conditions set out in the marketing authorisation shall be applied.

5.Samples shall be kept at the disposal of the competent authorities for the following periods:

(a)Reference samples and/or retention samples from each batch of finished product shall be retained for at least one year after the expiry date. The reference sample shall be contained in its finished immediate packaging.However, in the case of large volume presentations, where it is not feasible to retain samples from each batch in its final packaging, the manufacturer shall ensure that sufficient representative samples of each batch are retained and that the container used for storage is composed of the same material as the immediate container in which the product is marketed.

(b)Reference samples of materials used in the manufacture of veterinary medicinal products, other than solvents, gases or water, shall be kept for at least two years after the release of the product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter.

(c)Samples of packaging materials shall be kept for the duration of the shelf-life of the finished product concerned. For this purpose, retention of printed materials as part of the reference and/or retention samples is also acceptable.

For finished products, reference and retention samples may be regarded as interchangeable.

6.Reference samples shall be of sufficient size to permit the carrying out on at least two occasions of the full analytical controls on the batch in accordance with the marketing authorisation.

7.In cases when the marketing authorisation holder is not the entity responsible for batch release or when several sites are responsible for the manufacture or batch release, the responsibility for the taking and storing of reference and retention samples shall be defined in writing.

8.The ability to do relevant testing throughout the shelf-life of the veterinary medicinal product shall be ensured.

9.For veterinary medicinal products that are parallel traded, samples shall be retained as set out in this paragraph.Physical samples of packaging materials used in the re-packaging process, such as labels, carton, patient information leaflet or other package inserts, shall be retained for the duration of the shelf-life of the re-packaged finished product.A retention sample of the re-packaged finished product shall:

(a)be taken for each re-packaging operation;

(b)be retained for at least one year after the expiry date of the re-packaged finished product;

(c)represent the re-packaged finished product released for the market;

(d)include the immediate packaging as well as the outer packaging.

By way of derogation from the third subparagraph, if the outer packaging of the veterinary medicinal product is not opened during the re-packaging process, only the outer packaging materials of the re-packaged finished product shall be retained in accordance with the second subparagraph.

Defined terms · 30

Show every defined term

airlock
means an enclosed space with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards).
area
means a space.
aseptic processing/manufacturing
means processing or manufacturing activities performed under conditions which prevent contamination;
batch
means a defined quantity of materials or product that undergo the same process(es) so that it can be expected to be homogeneous.
bracketing
means an approach such that only the extremes of certain predetermined factors are tested or validated.
bulk product
means any product which has completed all processing stages up to, but not including, final packaging;
campaign manufacture
means the manufacture of a series of batches of the same product in sequence in a given period of time followed by strict adherence to preestablished control measures before transfer to another product.
clean area
means an area designed, maintained, and controlled to prevent particle and microbiological contamination;
closed system
means a system designed and operated so as to avoid exposure of the product or material to the room environment.
contained area
means an area that is designed (including air handling and filtration), maintained and controlled so as to prevent contamination of the external environment by biological or other agents;
cross-contamination
means the contamination of a material or a product with another material or product;
finished product
means a veterinary medicinal product that has undergone all the stages of production, including packaging in its final container;
in-process controls
means the checks performed during production in order to monitor and, if necessary, adjust the process to ensure that the product conforms to the required specifications.
intermediate product
means a partly processed material which must undergo further manufacturing steps before it becomes a bulk product;
isolator
means an enclosure capable of being subject to reproducible interior bio-decontamination, with an internal work zone meeting grade A conditions that provides uncompromised, continuous isolation of its interior from the external environment (e.g. surrounding cleanroom air and personnel).
manufacturing site
means a site that is engaged in any of the activities for which a manufacturing authorisation is required in accordance with Article 88(1) of Regulation (EU) 2019/6;
matrix
means an approach where a subset of the total number of possible samples for all factor combinations is tested at a specified time point and another subset of samples is tested for all factor combinations at a subsequent time point.
packaging
means all operations, including filling (with the exception of sterile filling) and labelling, which a bulk product has to undergo in order to become a finished product;
packaging material
means any material employed in the packaging of a veterinary medicinal product, excluding any outer packaging used for transportation or shipment.
pharmaceutical quality system
means the total sum of the measures implemented as part of the manufacturing process to ensure that medicinal products are of the quality required for their intended use;
qualification
means the process of demonstrating that entities, premises, equipment, utilities, systems or materials are suitable for the intended task and can deliver the expected outcomes;
quality risk management
means a systematic process, applied both proactively and retrospectively, for the assessment, control, communication and review of risks to the quality of the veterinary medicinal product across the product’s lifecycle;
quarantine
means the isolation – physically or by other effective means – of materials, intermediate, bulk or finished products whilst awaiting a decision on their release or refusal;
reconciliation
means a comparison, having due regard for normal variation, between the amount of product or materials theoretically and actually produced or used;
reference sample
means a sample of a batch of materials used in the manufacture of a veterinary medicinal product or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned;
reprocessing
means the treatment of all or part of a batch of product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations;
retention sample
means a sample of a fully packaged unit from a batch of finished product which is stored for identification purposes;
segregated area
means an area within a manufacturing site that has separate storage, separate production suite with separate HVAC (heat, ventilation and air conditioning), dedicated equipment reserved solely for the production of one type of product with a specific risk profile and restrictions on the movement of personnel and equipment;
signed
means the record of the individual who performed a particular action or review.
validation
means the process of demonstrating that a method or process is suitable for its intended use;