QUALITY ASSURANCE

Why Validation is required for the Manufacture of Medicinal Product?

TABLE OF CONTENTS

SUMMARY1

Introduction2

Medicinal Product Terms3

Quality Management Systems4

Quality Risk Management5

Discussion7

Medicinal Product - Key Product Quality Attributes and Process Parameters7

Key Enablers for a QMS8

Product Lifecycle Activities9

Conclusion10

REFERENCES12

SUMMARY

Nursing and healthcare has been an important aspect of society as we speak. Considering the kind of issues and cases that have risen in the past and continue to excel are the instruments, tools, technologies and utensils that have been developed in the light of understanding and comprehending the kind of issues and concerns, which shall make way for a better understanding and comprehension of nursing practices that are at hand.

The purpose of drafting this paper is to evaluate and analyze the kind of steps and measures that are being undertaken in the light of medicinal instruments. Our major focus shall be invested into the measures and steps that are being undertaken towards improving the current performance of the instruments and tools that are being undertaken in the light of creating and understanding the kind of issues and concerns, which have paved way for yielding improved performance and resulted in speedy recovery.

Why Validation is required for the Manufacture of Medicinal Product

Introduction

Medicinal products used in the context of treating patients need to be assessed and speculated from root to tip (Fall Edwards, 2005, pp.217). This is because, just like the several other disciplines related to human services, healthcare and nursing is one profession where absolutely no room for flaw, fault or failure exists, since any of these could cause irrevocable casualty, reaction, or even death (Alison, 2007, pp.74).

Though in this modern world the technology is changing very vastly with a very strong pace in advancement NHS has the capability to adopt the new advancement along with the new interventions (Black, 1998, pp: 127- 152).

It is necessary that the practitioner should have the full knowledge and grasp of the new and latest technologies in order to analyze and evaluate the information and the knowledge that has been collected by them in order to better treat the patients by the use of new machines and equipments (Bion, 2002, pp: 85-115).

This strategy is made just for the reason to make appropriate strategies with the intention to meet the requirements and demands of the health and social needs (Fall, 2005, pp: 217-251). It is facts that now in this modern era the relationship between a doctor and a patient have been change and seems to have a drastic changes comparing to the era of the olden times.

Both the parties have considered being a mutual decision maker in a particular decision about the patient (Clarke, 2004, pp: 17-52). In Other words it is said to be that the health care and the decision making in such situations are a two-way method (Rudolf, 2006, pp: 52-59).

Thus when patient is at a particular health care center and spending time and money, he has the right to expect the quality health care (Tempest, 2006, pp: ...