World Health Organization : Year 1994 ; World Health Organization, Vaccine Supply and Quality, Geneva, No. 94.10: Production and Control of Tetanus Vaccine

By World Health Organization

Book Id: WPLBN0000043265
Format Type: PDF eBook
File Size: 0.4 MB
Reproduction Date: 2005

Title:	World Health Organization : Year 1994 ; World Health Organization, Vaccine Supply and Quality, Geneva, No. 94.10: Production and Control of Tetanus Vaccine
Author:	World Health Organization
Volume:
Language:	English
Subject:	Health., Public health, Wellness programs
Collections:	Medical Library Collection, World Health Collection
Historic Publication Date:
Publisher:	World Health Organization


Citation APA MLA Chicago Organization, W. H. (n.d.). World Health Organization : Year 1994 ; World Health Organization, Vaccine Supply and Quality, Geneva, No. 94.10. Retrieved from http://gutenberg.cc/

Description
Medical Reference Publication

Excerpt
Although an essential activity, auditing is not necessarily welcomed by all manufacturers. Therefore, the right to perform auditing must be clearly given to the NCA by legislation. Auditing should be made part of the registration process, and to facilitate continued assurance of quality, it should be stipulated a continuous and regular activity.

Table of Contents
CONTENTS: 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.1Preliminary assessment of acceptability ..............................................1 1.2. Consistency of production..............................................2 1.3. Inspection or audit . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 . Guidelines for auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 . Auditing techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3.1. Performance audits . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3.2. System audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4 . Internal audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4.1. The Quality Assurance Unit . . . . . . . . . . . . . . . . . . . . . 6 4.2. Evaluation and reporting . . . . . . . . . . . . . . . . . . . . . . . 6 5 . External audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5.1. Audit planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5.2. Audit visit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5.3. Recommendations for auditing . . . . . . . . . . . . . . . . . . . 9 6 . Follow-up programme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 7 . Supplier audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 8 . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11