The first book of this collection “Apuntes on pharmaceutical technology ” edited in May of l999, he was of “Validación an industrialist. His application in the pharmaceutical industry and play in tune ”
Exhausted the first edition of this book and having passed 8 years from his presentation on the market, the publisher and authors we have conscience that has rained very much since then.
Our illusion and commitment has been to write a new book that being based on the already classic beginning of the ratification, should contribute the application of new concepts of quality, integrating the studies of analysis and management of risks in the development and manufacture of medicines, especially, the studies and experimental processes of qualification and ratification.
By it, in this new edition, there are studied 20 topics, which gather the current theoretical concepts, and his practical application, from qualification and ratification in the manufacture of the principal forms of dosage, bearing in mind the current regulations and requirements of the sanitary authorities of the European Union and of the United States of America.
With the application of the current regulations of the FDA, and the EMEA, the ICH Q7a, ICHQ8, ICHQ9 ICH Q10 and the application of PAT, we have an official way of integral quality to be continued, that comes to complete the GMP.
Therefore, with the reading, and study of this book, the specialists of the industry chemist pharmacist, engineers, chemists, veterinarians, biológos, pharmacists etc, will have the opportunity to know in his knowledge and to reach in his practical application higher levels of reliability and productivity and, in general, to make products with the quality needed from minor cost.
It is a book of text, of indispensable reading in courses of industrial specialization.
Content: 888 pages.
INTRODUCTION.
TOPIC 1.-Concepto of management of the integral quality in the pharmaceutical industry.
Garcia Montoya, Becomes incarnate and Salazar, Ramon
TOPIC 2.-Introducción to the study of the ratification. Concept and generalities. Salazar, Ramon and Leader, José Maria
TOPIC 3.-Análisis of the risk and management of the risk
in the pharmaceutical quality. Salazar, Ramon and Leader, José Maria
TOPIC 4.-Estadistica industrialist: application in the design, manufacture and control of medicines. Practical examples in ratification processes.
Rosemary Obón, Miquel and Suñé i Negre, Josep Ma
TOPIC 5.-Estudio of the regulative regulations for the authorization and functioning of pharmaceutical laboratories: technical memory of the facilities. Esquerdo, Ramon and Reinés, Albert
TOPIC 6.-Validación of water production systems in the pharmaceutical industry. Lerín, Ignacio and Salazar, Ramon
TOPIC 7.-Validación of air treatment systems in the pharmaceutical industry. Beaus Rosemary, Rafael and Salazar, Ramon
TOPIC 8.-Validación of systems of treatment of compressed air, steam and other gases. Practical examples. CastejónQuílez, Marian and Beaus Romero, Rafael
TOPIC 9.-Validación of computer systems in industrial processes. Introduction. MartínezDíaz, Luxuriant José Ramón y Orihuela, Juli and Portell Santisteban, Núria
9.1.-Validación of computerized management systems.
Luxuriant Orihuela, Juli
9.2.-Validación of control computer systems. MartínezDíaz, José Ramón y Portell Santisteban, Núria
TOPIC 10.-Cualificación of teams. Lerín, Ignacio and Salazar, Ramon
TOPIC 11.-Estudios of process ratification in pharmaceutical development.
Love it Navarrese, Joaquim
TOPIC 12.-Validación of the production process of solid forms: tablets. Esquerdo López, Ramón Mario
TOPIC 13.-Validación of the manufacture of forms of dosage you liquidate oral: dissolutions and oral suspensions. Castejón, Marian and Miñarro, Montserrat and Alavedra, Montserrat
TOPIC 14.-Validación of the manufacture of forms of dosage you liquidate parenterales.
Love it Navarrese, Joaquim
TOPIC 15.-Validación of the manufacture of forms of local application.
1st parte.-emulsions and gels AlavedraFarell, Montserrat
2nd parte.-Microemulsiones and liposomes.
García Celma, Maria José y Alavedra, Montserrat and Solans, Conxita
TOPIC 16. - Ratification of the production process of forms of dosage in the shape of aerosol.
HalbautLyda and Aparici Manel
TOPIC 17.-Validación cleanliness methods.
Pujol, Martí and Buoy, mayte
TOPIC 18.-Validación of analytical methods. Concept and generalities. Practical examples.
Ruiz, Jordi and Pérez Pilar
TEMA19.-Validación of methods bioanáliticos. Practical example.
Grandson, Carlos and Doménech, José
TOPIC 20.-Homologación and providers' ratification. Beaus Codes, Rafael and Pujol, Martí
Epilogue.
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