PHARMACEUTICAL

Improving Quality Operations of a Pharmaceutical Supply Chain



Abstract

The importance of the container relates to its role in maintaining the safety of the drug product beyond the factory floor. Thus, much attention must be directed at ensuring that the container closure system is effective to ensure the drug's purity and quality. The pharmaceutical supply chain, again, is a very complex network. A small number of later guidance documents published subsequently by MHRA deal with more specific issues related to container closure development, and are often quite focused in their subject matter. The ICH guidance documents are quite different from those of regulatory agencies, in that they contain supplementary information. This additional information is sometimes incorporated into the MHRA and EMA regulatory guidance documents by reference, when the regulatory guidance postdates the ICH guidance. Many statements in ICH Q10 have important implications for the correct and consistent use of statistics in the day-today implementation of pharmaceutical quality systems. Addressing these harmonized recommendations proactively and in context can help to strengthen one's quality system and thereby reduce rejects and recalls.

TABLE OF CONTENTS

ABSTRACTI

INTRODUCTION1

Pharmaceutical Supply Chains1

Manufacturers2

Pharmacy Benefit Manager (PBM)3

Pharmacies4

Distribution4

INTERNATIONAL CONFERENCES ON HARMONIZATION AND PHARMACEUTICAL QUALITY SYSTEM5

CONTENT OF ICH GUIDELINES9

TRADITIONAL QUALITY BY TESTING (QBT) DEVELOPMENT AND MANUFACTURING: THE CURRENT PARADIGM AND A CASE FOR CHANGE12

EFFECTS OF THE ICH GUIDELINES13

MAINTAINING PACKAGE QUALITY15

GOOD MANUFACTURING PROCESSES16

TESTING MATERIALS USED IN PACKAGING18

Plastics Containers for Pharmaceutical Products18

CONCLUSION19

REFERENCES22

Improving Quality Operations of a Pharmaceutical Supply Chain

Introduction

In the pharmaceutical industry, a marketed drug product is more than the tablet dispensed to the patient; it includes the container that is considered an integral part of the product. The importance of the container relates to its role in maintaining the safety of the drug product beyond the factory floor. Thus, much attention must be directed at ensuring that the container closure system is effective to ensure the drug's purity and quality. Proof of this capability is part of the regulatory submission to obtain marketing approval for the drug product. Testing to show suitability of the container closure system must be conducted and data must be reviewed by the Medicine and Healthcare products Regulatory Authority (MHRA) prior to marketing. Further, any change in the system of container closure must be reported to the MHRA in order to maintain market approved status. Nevertheless, information is limited with respect to expectations for managing container closure systems from a regulatory perspective (Blanchard & Fabryky, 2006, pp. 212).

Pharmaceutical Supply Chains

The pharmaceutical supply chain, again, is a very complex network. According to the Health Strategies Consultancy LLC (2005), "there are many variations on this basic structure [of the pharmaceutical supply chain] as the players in the supply chain are constantly evolving, and commercial relationships vary considerably by geography, type of medication, and other factors". In a way, this sector is extremely multidisciplinary. The constituents of this network are concerned with more factors than a typical manufacturing process. There are many governmental issues and concerns with which all members of the supply chain must abide, also many regulations set by different medical ...