A Review on Pharmaceutical Validation and Its Implications.
Artigo
em Inglês
| IMSEAR
| ID: sea-157241
ABSTRACT
The process validation is establishing documented evidence which provides high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality characteristic. According to GMP validation studies are essential part of GMP these are required to be done as per predefined protocols. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus the validation is an essential part of the quality assurance.
Texto completo:
DisponíveL
Índice:
IMSEAR (Sudeste Asiático)
Idioma:
Inglês
Ano de publicação:
2013
Tipo de documento:
Artigo
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