Cover
FAO ANIMAL PRODUCTION AND HEALTH PAPER 128





Quality control testing of contagious bovine pleuropneumonia live attenuated vaccine
Standard operating procedures



CONTENTS

by
Joseph Litamoi, Vilmos J. Palya and Daouda Sylla
Pan African Veterinary Vaccine Centre (PANVAC)
Addis Ababa, Ethiopia
and
Mark M. Rweyemamu
Emergency Prevention System for Transboundary
Animal and Plant Pests and Diseases (EMPRES)
Infectious Disease Group
Animal Health Service
FAO Animal Production and Health Division

The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.



M-27
ISBN 92-5-103796-5



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Food and Agriculture Organization of the United Nations Rome, 1996
© FAO 1996


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CONTENTS

SOP 1:Formulation of Media and Solutions
SOP 2:Estimation of viable Mycoplasma Content of CBPP Vaccines (Microtitration Method)
SOP 3:Test for Sterility
SOP 4:Digitonin Sensitivity Test the for Detection of Acholeplasma Contamination
SOP 5:The Growth Inhibition Test for Identity of M.mycoidessubsp. mycoides
SOP 6:Agar Gel Immunodiffusion (AGID) Test for Identification of M.mycoides subsp.mycoides
SOP 7:The Test for Streptomycin Resistance for the Identification of Streptomycin Resistant Variant of M.mycoides subsp.mycoides
SOP 8:Biochemical Tests for the Identification of M.mycoides subsp.mycoides
SOP 9:Innocuity Test in Laboratory Animals
SOP 10:Safety Test in Cattle
SOP 11:The Test for Potency in Cattle
Definitions
Submission Forms for CBPP and Combined CBPP-Rinderpest Vaccine
Suppliers of Laboratory Equipment and Reagents

FOREWORD

It is generally accepted that vaccines are medical products and their preparation should therefore be governed by the principles of good manufacturing and laboratory practices (GMP/GLP).

Contagious bovine pleuropneumonia (CBPP) vaccine is now considered Africa's second priority veterinary vaccine after that for rinderpest. CBPP vaccine production and quality control procedures in Africa widely vary from one laboratory to another. Therefore the need for standardised and/or harmonised vaccine production and quality control techniques become evident. This publication attempts to address the quality control aspects of this need.

The techniques described in this SOP manual represent the experience of the Pan African Veterinary Vaccine Centre (PANVAC) in its CBPP vaccine quality control services over the last four years or so.

Some of the techniques are still undergoing further standardisation and additional procedures will be included at later stages. Nevertheless it is hoped that the adoption of the techniques described in this manual by individual vaccine producer laboratories in Africa should facilitate the use of harmonized CBPP vaccine quality testing methods with the overall objective of implementing the OIE requirements for CBPP vaccine. In this regard quality control should cover both in-process and final product testing.

The authors wish to acknowledge the collaboration of national vaccine laboratories in Africa and the CIRAD-EMVT, France during the elaboration of the techniques described in the SOP.