Q: What is the regulator’s position on these standards?
Answer: We cannot speak for the <insert region> regulators
views, but we can quote the Medicines and Healthcare Products Regulatory Agency in the UK who have been endorsing and supporting the
use of these standards for over a decade. The following is from the foreword to PS 9004 which is a guide to implementing PS 9000.
The current head of the MHRA Inspection and enforcement division is preparing a similar foreword and endorsement for the revised PS
9000 which will be launched in September 2011.
The EU Guide to Good Manufacturing Practice (GMP) emphasises the need for pharmaceutical
manufacturers and assemblers to ensure that the packaging materials are of the appropriate quality. Not only is this in the interests
of patient safety, but also in the pharmaceutical industry where the increasing use of automated packaging processes relies heavily
on the consistent quality of packaging components.
Each year the Medicines and Healthcare products regulatory Agency (MHRA) receives
and investigates a number of reports of quality defects concerning medicinal products. A significant proportion of these concern packaging
errors, some of which are attributable to the use of packaging materials not of the desired quality.
The introduction of PS 9000
in 2001 by the Pharmaceutical Quality Group of the Institute of Quality Assurance was a key step in promoting the understanding of
GMPs relevant to the suppliers of packaging materials to the pharmaceutical industry. PS 9000 focussed on the development and implementation,
by suppliers, of a quality management system designed to provide assurance of the quality of their products and to enhance customer
satisfaction.
Its contribution was welcomed by both industry and the Regulator. PS 9004 is aimed at increasing the awareness of the
quality management system requirements embodied in PS 9000. This comprehensive and easy to follow guide explains further the GMP requirements
of PS 9000. It adopts a risk assessment approach to the identification and implementation of preventive action and uses case studies
to illustrate areas of GMP risk.
The MHRA encourages the introduction of PS 9004 designed to improve product and service quality in
the supply of packaging materials for medicinal products, for the benefit of patients and the pharmaceutical industry as a whole.
John
Taylor
Quality and Systems Manager
Inspection and Enforcement Division, MHRA
