Paragraph 8A Good manufacturing practiceF1

England, Wales and Scotland

(1)

A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with this paragraph, whether the manufacturing is performed by the holder or another person.

(2)

The manufacturing operations must be conducted in accordance with a written methodology, to be known as the “pharmaceutical quality system” or “PQS”.

(3)

The PQS must be—

(a)

clear;

(b)

systematically reviewed from time to time in the light of experience; and

(c)

capable of consistently manufacturing veterinary medicinal products which are of the required quality and which meet the requirements of the relevant marketing authorisation.

(4)

The critical steps of the manufacturing process set out in the PQS must be validated.

(5)

Any significant amendments to the PQS must be validated.

(6)

The PQS must provide for—

(a)

appropriately qualified and trained personnel;

(b)

adequate premises and space;

(c)

suitable equipment and access to services;

(d)

suitable materials, containers and labelling;

(e)

relevant procedures and instructions;

(f)

suitable storage and transport;

(g)

investigation into complaints and defects.

(7)

The PQS must provide for any significant deviations from its provisions to be—

(a)

fully recorded, and

(b)

investigated, with appropriate corrective and preventative action implemented.

(8)

The holder of a manufacturing authorisation must ensure that records of the manufacturing process, including distribution, are kept in a comprehensible and accessible form until the later of—

(a)

the date which is five years after the date on which the veterinary medicinal product is placed on the market;

(b)

the date which is one year after the expiry date of the batch of veterinary medicinal product.

(9)

In this paragraph, a process (or part of a process) is “validated” if scientific evidence is assembled which demonstrates that it is capable of consistently delivering expected results.

Annotations

Textual amendments

F1: Sch. 2 paras. 8A, 8B inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 88