| Titre : |
Pharmaceutical quality systems |
| Type de document : |
texte imprimé |
| Auteurs : |
Schmidt Oliver, Auteur |
| Editeur : |
Denver : I.H.S |
| Année de publication : |
2000 |
| Importance : |
370p. |
| Format : |
26 cmx 17 cm |
| ISBN/ISSN/EAN : |
1-57491-109-1 |
| Note générale : |
index |
| Langues : |
Français (fre) |
| Mots-clés : |
Pharmaceutical |
| Index. décimale : |
615-31.1 |
| Résumé : |
When a pharmaceutical company decides to build a Quality System, it
has to face the fact that there aren't any guideline that define exactly how
such a system has to be built. With terms such as quality system, quality
assurance, and quality management used interchangeably, even defining the
system's objectives is a problem. This book provides a practical guide to
building a quality system. Beginning with explanations of key terms and
concepts, it covers ISO 9000 and GMP and how to combine them, and includes a
matrix showing their similarities and differences. Implementation reviews
illustrate how Quality (Management) Systems have been installed successfully
in pharmaceutical companies. Also covered are the individual components of a
Quality System; auditing, validation, and supplier qualification systems;
and Hazard Analysis Critical Control Points (HACCP).
|
Pharmaceutical quality systems [texte imprimé] / Schmidt Oliver, Auteur . - [S.l.] : Denver : I.H.S, 2000 . - 370p. ; 26 cmx 17 cm. ISSN : 1-57491-109-1 index Langues : Français ( fre)
| Mots-clés : |
Pharmaceutical |
| Index. décimale : |
615-31.1 |
| Résumé : |
When a pharmaceutical company decides to build a Quality System, it
has to face the fact that there aren't any guideline that define exactly how
such a system has to be built. With terms such as quality system, quality
assurance, and quality management used interchangeably, even defining the
system's objectives is a problem. This book provides a practical guide to
building a quality system. Beginning with explanations of key terms and
concepts, it covers ISO 9000 and GMP and how to combine them, and includes a
matrix showing their similarities and differences. Implementation reviews
illustrate how Quality (Management) Systems have been installed successfully
in pharmaceutical companies. Also covered are the individual components of a
Quality System; auditing, validation, and supplier qualification systems;
and Hazard Analysis Critical Control Points (HACCP).
|
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