Biomedical Engineering Reference
In-Depth Information
TABLE 3.2 ( Continued )
Regulatory Expectations when
Executing Risk Assessments
Practical Considerations
Ultimately be linked to the
protection of the patient
The requirement is taken directly from ICH Q9 “the
protection of the patient by managing the risk to
quality should be considered of prime importance.”
Risk assessment activities should not be executed
with the initial intention to reduce activities
(validation, sampling, etc.). Properly executed
assessments will naturally provide opportunities to
reduce activities for low risk items. Items that
require additional work, when completed, provide
for reduction in variation and lower cost of quality,
increasing profitability.
Contains objective risk
mitigation/reduction plans.
Organizations must have procedures that provide
standard ways to determine if hazards require risk
reduction or can be accepted in their current state.
The plans must be documented, approved (they
can exist as a part of the original assessment), and
reviewed as required.
Companies should ask the following questions when setting up or evaluating
their risk communication process.
• What mechanisms exist for the company to quickly respond to risk?
• Are these mechanisms two way?
• Are there robust lines for the communication of risk robust both internally
as well as externally?
• Are there policies that facilitate external risk communications with the pub-
lic, regulators, and notified bodies?
• Does the company have a risk register, or similar method, to collect asso-
ciated product and process risk as a method to discuss the site's overall
residual risk?
3.2.3 Risk Registers
There is an expectation that pharmaceutical manufacturing sites have specific
high level risk overview documents known as risk registers, or risk master plans .
The initial expectation was clearly and formally laid out in the MHRA's Good
Manufacturing Practice (GMP)—Quality Risk Management: frequently asked
questions:
... a risk register (or equivalent title document) should list and track all key risks as
perceived by the organisation and summarise how these have been mitigated. There
Search WWH ::




Custom Search