Risk Management shall be performed using a systematic process, designed to coordinate, facilitate and improve science-based decision marking with respect to risk identified in evaluation of the activities related to manufacturing, packing, testing, storage and transportation of drug substance procured at site.
1. SCHEDULE M
Section 2. quality Risk Management
- The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient
- The level of effort, formality and documentation of the QRA process is commensurate with the level of risk.
2. WHO
TRS no.961-2013-WHO guideline in quality risk management
Section 1.2 Principles of quality risk management
- The evaluation of the risk to quality should be based on scientific knowledge and ultimately linked to the protection of the patient.
- The level of effort, formality and documentation of the QRM process should be commensurate with the level of risk.
3. ICH
QUALITY RISK MANAGEMENT Q9(R1)
Section 3. PRINCIPLES OF QUALITY RISK MANAGEMENT
- The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient.
- The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.
4. PIC/S
PE 009-17(Annexes) Guide to Good Manufacturing Practice for Medicinal Products Annexes
Annex 20 Quality Risk Management
PRINCIPLES OF QRA
14. Two primary principles of quality risk management are:
- The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and
- The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.
5. EMA
EMA-ICH guideline Q9 R1 on QRA Step 5.
3. Principles of quality risk management
Two primary principles of QRA are:
- The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient.
- The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.
6. FDA
Q9(R1) QRA Guidance for Industry:
III. PRINCIPLES OF QRA (3)
Two primary principles of quality risk management are:
- The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient.
- The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.
Read also:
Resource Person: Dr. Prasadhi Shiva
