S.I. No. 562/2025 - Industrial Training (Pharmaceutical Industry) Order 2025

1. This Order may be cited as the Industrial Training (Pharmaceutical Industry) Order 2025.

2. The following activities are hereby declared to be designated industrial activities for the purposes of the

Industrial Training Act 1967

(No. 5 of 1967)

(a) In the pharmaceutical industry

(i) Operating and monitoring various machines, processes and systems used in bioprocessing or chemical processing, including reactors, mixers, pumps, and control systems;

(ii) Adjusting process parameters and control systems, including but not limited to temperature, pressure, flow rates, and chemical concentrations, to maintain optimal conditions for production and ensuring product quality;

(iii) Monitoring bioprocessing and chemical processing activities by collecting samples, conducting tests, and analysing data for product quality assurance and assessment in accordance with quality management systems;

(iv) Identifying and addressing equipment malfunctions, performing routine maintenance, and collaborating with maintenance teams; and

(v) Documenting bioprocessing and chemical processing activities and maintaining accurate and comprehensive records such as batch records, log sheets, labels, and general manufacturing records.

3. In this Order

“bioprocessing” means the sum of techniques involved in developing products with specific characteristics based on living cells or parts of such;

“chemical processing” means the conversion of raw materials into products through chemical reactions and separation techniques;

where for the purposes of these definitions, “products” means medicinal or pharmaceutical products.

4. The provisions of this Order shall not apply to any activity of industry for which a separate industrial training order is, for the time being, in force.

GIVEN under the Official Seal of An tSeirbhís Oideachais Leanúnaigh agus Scileanna,

13 November 2025.

The Seal of An tSeirbhís Oideachais Leanúnaigh agus Scileanna was affixed in the presence of

SEAN AYLWARD

SOLAS Chairman

a member of An tSeirbhís Oideachais Leanúnaigh agus Scileanna, authorised by An tSeirbhís Oideachais Leanúnaigh agus Scileanna to act in that behalf.

NESSA WHITE

SOLAS CEO

a member of An tSeirbhís Oideachais Leanúnaigh agus Scileanna, authorised by An tSeirbhís Oideachais Leanúnaigh agus Scileanna to act in that behalf.

EXPLANATORY NOTE

(

This note is not part of the Instrument and does not purport to be a legal interpretation.

)

An tSeirbhís Oideachais Leanúnaigh agus Scileanna was established under the

Further Education and Training Act 2013

to promote training in industry and commerce.

This Order defines the activities of the pharmaceutical industry in relation to which An tSeirbhís Oideachais Leanúnaigh agus Scileanna shall exercise its functions in the creation of statutory apprenticeships.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

2

nd December,

2025.

An tSeirbhís Oideachais Leanúnaigh agus Scileanna, after making such inquiries as it thinks proper and consultation with organisations and associations appearing to it to be representative of substantial numbers of employers in the activities referred to in this Order and of substantial numbers of persons employed in such activities, in exercise of the powers conferred on it by

section 23

of the

Industrial Training Act 1967

(No. 5 of 1967) and by

section 38

of the

Further Education and Training Act 2013

(No. 25 of 2013) hereby makes the following Order