Medicinal Products Rules, 2018

L.N. 3 of 2018

VETERINARY SERVICES ACT

(CAP. 437)

Good Manufacturing Practice for Veterinary

Medicinal Products Rules, 2018

IN exercise of the powers conferred by articles 30 and 31 of the

Veterinary Services Act, the Minister for the Environment, Sustainable

Development and Climate Change in concurrence with the Minister for

Health, after consultation with the Head of the National Veterinary

Laboratory, has made the following rules:-

(1) The title of these rules is the Good Manufacturing Citation and

scope.

Practice for Veterinary Medicinal Products Rules, 2018.

(2) The scope of these rules is to transpose Commission

Directive 91/412/EEC laying down the principles and guidelines of

good manufacturing practice for veterinary medicinal products.

(3) These rules lay down the principles and guidelines of good

manufacturing practice for veterinary medicinal products whose

manufacture requires the authorisation referred to in Article 44 of

Directive 2001/82/EC.

(1) For the purposes of these regulations and unless the Interpretation.

context otherwise requires, the following definitions shall apply

"the Act" means the Veterinary Services Act;

"the Commission" means the European Commission;

"competent authority" means the Department of Veterinary

Services, or any other authority or authorities authorised by the

Department of Veterinary Services to act on its behalf;

"good manufacturing practice" shall mean the part of quality

assurance with ensures that products are consistently produced and

controlled to the quality standards appropriate to their intended use;

"manufacturer" shall mean any holder of the authorization

referred to in Article 44 of Directive 2001/82/EC;

"pharmaceutical quality assurance" means the sum total of the

organized arrangements made with the object of ensuring that

veterinary medicinal products are of the quality required for their

intended use;

"qualified person" shall mean the person referred to in Article

52 of Directive 2001/82/EC;

"veterinary medicinal products" means veterinary medicinal

products as set out in Article 1(2) of Council Directive 2001/82/EC of

6 November 2001 on the Community code relating to veterinary

medicinal products.

(2) Unless the context otherwise requires, words and phrases

used in these rules which are not defined herein shall have the same

meaning assigned to them in article 2 of the Act.

(1) The competent authority shall, by means of the

repeated inspections referred to in Article 80 of Directive 2001/82/

EC, ensure that manufacturers respect the principles and guidelines of

good manufacturing practice laid down by these rules.

(2) For the interpretation of these principles and guidelines of

good manufacturing practice, the manufacturers and the competent

authority shall refer to the detailed guidelines referred to in Article 51

of Directive 2001/82/EC.

(3) The detailed guidelines referred to in sub-rule (2) are

published by the Commission in the "Guide to good manufacturing

practice for medicinal products" and in its annexes.

(1) The manufacturers shall ensure that the

manufacturing operations are carried out in accordance with good

manufacturing practice and with the manufacturing authorisation.

(2) For veterinary medicinal products imported from third

countries, the importer shall ensure that the veterinary medicinal

products have been manufactured by manufacturers duly authorized

and conforming to good manufacturing practice standards, at least

equivalent to those laid down by the Community.

(1) The manufacturer shall ensure that all

manufacturing operations subject to an authorization for marketing

are carried out in accordance with the information given in the

application for marketing authorization as accepted by the relevant

competent authorities.

(2) The manufacturers shall regularly review their

manufacturing methods in the light of scientific and technical

progress.

(3) When a modification to the marketing authorization

dossier is necessary, the application for modification must be

submitted to the competent authorities.

(1) The manufacturer shall establish and implement an Quality

effective pharmaceutical quality assurance system, involving the management.

active participation of the management and personnel of the different

services involved.

It shall be the duty of the manufacturer to ensure that

Personnel.

(a)

at each manufacturing site there are a sufficient

number of competent and appropriately qualified personnel at

his disposal to achieve the pharmaceutical quality assurance

objectives;

(b) the duties of managerial and supervisory staff,

including the qualified person(s), responsible for implementing

and operating good manufacturing practice

(i)

are defined in job descriptions;

(ii) their hierarchical relationships are defined in

an organisational chart;

(iii) the job descriptions and organisational chart

mentioned in sub-rule (b)(i) and (ii) respectively are

approved in accordance with the manufacturer’s internal

procedures;

(c)

the staff referred to in paragraph (b) shall be given

sufficient authority to carry out their responsibilities correctly;

(d) personnel shall receive initial and continuing

training including the theory and application of the concept of

quality assurance and good manufacturing practice;

(e)

hygiene programmes adapted to the activities to be

carried out shall be established and observed. These

programmes include procedures relating to health, hygiene and

clothing of personnel.

(1) Premises and manufacturing equipment shall be Premises and

located, designed, constructed, adapted and maintained to suit the equipment.

intended operations.

(2) Layout, design and operation must aim to minimize the

risk of errors and permit effective cleaning and maintenance in order

to avoid contamination, cross contamination and, in general, any

adverse effect on the quality of the product.

(3) Premises and equipment intended to be used for

manufacturing operations which are critical for the quality of the

products shall be subjected to appropriate qualification.

(1) (a) The manufacturer shall have a system of

documentation based upon specifications, manufacturing formulae

and processing and packaging instructions, procedures and records

covering the different manufacturing operations that they perform.

(b) Documents shall be clear, free from errors and

kept up to-date.

(c) Pre-established

procedures

for

general

manufacturing operations and conditions shall be available, together

with specific documents, for the manufacture of each batch. This set

of documents shall make it possible to trace the history of the

manufacture of each batch.

(d) The batch documentation shall be retained for

at least one year after the expiry date of the batches to which it

relates, or at least five years after the certification referred to in

Article 55 (3) of Directive 2001/82/EC, whichever is the longer.

(2) (a)

When electronic, photographic or other data

processing systems are used instead of written documents, the

manufacturer shall have validated the system by proving that the data

will be appropriately stored during the anticipated period of storage.

(b) Data stored by these systems shall be made readily

available in legible form. The electronically stored data shall be

protected against loss or damage of data which may be done by

duplication or back-up and transfer onto another storage system.

(1) The different production operations shall be carried

out according to pre-established instructions and procedures and in

accordance with good manufacturing practice.

(2) Adequate and sufficient resources shall be made available

for the in-process controls.

(3) Appropriate technical and, or organizational measures

shall be taken to avoid cross contamination and mix-ups.

(4) Any new manufacture or important modification of a

manufacturing process shall be validated.

(5) Critical phases of manufacturing process shall be regularly

revalidated.

(1) The manufacturer shall establish and maintain a Quality control.

quality control department

Provided that this department shall be placed under the

authority of a person having the required qualifications and shall be

independent of the other departments.

(2) The quality control department shall have at its disposal

one or more quality control laboratories appropriately staffed and

equipped to carry out the necessary examination and testing of

starting materials, packaging materials and intermediate and finished

products testing

Provided that, resorting to outside laboratories is

authorized in accordance with rule 12 and after the authorization

referred to in Article 24(b) of Directive 2001/82/EC has been granted.

(3) During the final control of finished products before their

release for the sale or distribution, in addition to analytical results, the

quality control department shall take into account essential

information such as the production conditions, the results of in-

process controls, the examination of the manufacturing documents

and the conformity of the products to their specifications including

the final finished pack.

(4) (a)

Samples of each batch of finished products shall be

retained for at least one year after the expiry date.

(b) Samples of starting materials other than solvents,

gases and water used shall be retained for at least two years after the

release of the product

Provided that this period may be shortened if their

stability, as mentioned in the relevant specification, is shorter.

(c)

All the samples shall be maintained at the disposal

of the competent authority.

(d) For certain veterinary medicinal products

manufactured individually or in small quantities, or when their

storage could raise special problems, other sampling and retaining

conditions may be defined in agreement with the competent authority.

(1) Any manufacturing operation or operation linked Work contracted

with the manufacture, which is carried out under contract, shall be the out.

subject of a written contract between the contract giver and the

contract acceptor.

(2) The contract shall clearly define the responsibilities of

each party and in particular the observance of good manufacturing

practice by the contract acceptor and the manner in which the

qualified person responsible for releasing each batch shall undertake

his full responsibilities.

(3) The contract acceptor shall not further sub-contract any of

the work entrusted to him by the contract giver without the written

authorization of the contract giver.

(4) The contract acceptor shall respect the principles and

guidelines of good manufacturing practice and shall submit to

inspections carried out by the competent authorities as provided for

by Article 80 of Directive 2001/82/EC.

(1) The manufacturer shall implement a system for

recording and reviewing complaints together with an effective system

for recalling promptly and at any time the veterinary medicinal

products in the distribution network.

(2) Any complaint concerning a quality defect shall be

recorded and investigated by the manufacturer.

(3) The competent authority shall be informed by the

manufacturer of any quality defect that could result in a recall or

abnormal restriction on the supply. In so far as possible, the countries

of destination shall also be indicated.

(4) Any recall shall be made in accordance with the

requirements referred to in Article 91 of Directive 2001/82/EC.

(1) The manufacturer shall conduct repeated self-

inspections as part of the quality assurance system in order to monitor

the implementation and respect of good manufacturing practice and to

propose any necessary corrective measures.

(2) Records of self-inspections and any further corrective

action shall be maintained.

€0.54