| |
Guideline
and Standards |
|
Description |
| |
EU GMP Annex 15 on Validation and Qualification in Operation |
|
Requirement of Good Manufacturing Practices (GMP) that
manufacturers identify what validation work is needed to
prove control of the critical aspects of their particular
operations related to equipment, process, facilities and
cleaning. |
| |
|
|
|
| |
Note for Guidance On Process Validation
|
|
This note for guidance is intended to demonstrate and
standardize the data that should be routinely included in
the marketing authorization dossier describing the
evaluation or validation of the manufacturing process and
distinguish them from those validation data which more
properly fall under the remit of GMP Inspection. |
| |
|
|
|
| |
|
|
|
