| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 5138985 | Microchemical Journal | 2018 | 13 Pages |
Abstract
The discussion emphasizes the aspects related to the Quality System, Production, Validation and Quality Control, proposing an integrated approach, which combines the GMP and ISO requirements (e.g., ISO 13485 and ISO 14971), following a Quality Risk Management (ICH Q9) and, where applicable, an integrated Pharmaceutical Quality System (ICH Q10) structure.
Keywords
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Fabio Geremia,