Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

Importancia y uso:

4.1 This guide is intended to provide guidance regarding the use of risk management in the development, day-to-day running, and continuous improvement of pharmaceutical processes incorporating Process Analytical Technology (PAT). A consistent approach to the use of risk methodologies should be adopted to ensure rapid transfer of process understanding within the development and manufacturing teams, and to the regulators where that is appropriate.

4.2 This guidance only covers those aspects of risk assessment related to “risk to product quality.” Other aspects (such as “risk to patient”) should be covered in the conventional manner.

Subcomité:

E55.11

Referida por:

D6792-23C, D6792-23C, E3106-22, E2500-20, E2500-20, D6792-23C, E2898-20A, E2891-20, E3418-23E01, E2629-20

Volúmen:

14.01

Número ICS:

11.120.10 (Medicaments)

Palabras clave:

critical quality attribute (CQA); manufacturing; process analytical technology (PAT); process understanding; risk assessment; risk management;