RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 48

logistical requirements and considerations when rolling out a QRM program and
the organizational training required for an effective QRM system.
3.2 QRM REGULATORY EXPECTATIONS
Working in this industry, we have a responsibility, within the clinical risk/benefit
construct for individual products, to produce safe and effective products. An
effective quality management system assists in meeting the responsibility. Risk
management is the enabling process in the design and implementation of that
quality management system [1]. Global regulations lay out the responsibilities:
The (social) responsibility of a pharmaceutical manufacturer is quite clear:
The holder of a manufacturing authorization must manufacture medicinal products so
as to ensure that they are fit for their intended use, comply with the requirements of
the Marketing Authorization and do not place patients at risk because of inadequate
safety, quality, or efficacy [2].
The responsibility of management within the company is also quite clear:
The attainment of this quality objective is the responsibility of senior management and
requires the participation and commitment by staff in many different departments and at
all levels within the company, by the company's suppliers, and by the distributors [3].
As is the method by which these quality objectives will be met:
To achieve the quality objective reliably there must be a comprehensively designed and
correctly implemented system of Quality Assurance Incorporating Good Manufactur-
ing Practice, and thus Quality Control and Quality Risk Management [3].
So, as detailed earlier, a modern pharmaceutical quality system cannot truly
function properly in the absence of an effective, integrated QRM system.
The expectations that regulators have for QRM have been laid out directly
through regulations or guidance by agencies, consortiums, and health organiza-
tions across the globe. ∗ These are clear indicators of an expectation for having
a fully embedded QRM process within the quality system. The days of having
a standalone risk assessment procedure, such as for failure modes and effects
analysis, are in the past.
Reviewing recent inspection observations is a good way to understand how
the expectations of international regulatory bodies on a given subject such as risk
management need to be put into practice. Recent observations show the impor-
tance of having both a fully embedded system of QRM and appropriately executed
risk assessments (see Table 3.1 for examples of observation deficiencies) [5,6].
∗ Chapter 3 of the EudraLexVol 4 GMPs “Premises and Equipment”. From a practical standpoint,
you cannot minimize risk without assessing it. You cannot assess risk unless you have standard tools.
You cannot have standard risk assessment tools without a system of risk procedures.