RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 54

TABLE 3.3 MHRA's List of Frequently Asked QRM Questions [42]
MHRA QRM Frequently
Asked Question

MHRA Response

1. Do all inspections cover the
QRM process?

Yes, QRM (QRM) is a requirement of Chapter 1 of the EU GMP Guide Part I. All manufacturing
authorization holders, third-country manufacturing sites, blood establishments, blood banks, and
active pharmaceutical ingredient manufacturers must have a system for QRM. Inspectors will review
the QRM system as part of the Quality Systems section of the inspection (along with complaints,
recalls, deviations, and product quality reviews, etc.). Additionally, inspectors may review specific
risk assessments when encountered during inspection. Inspectors will allocate time commensurate
with their perceived significance of the risk and if necessary request the company to produce a formal
summary of the risk assessment, key decisions, and conclusions, or take copies of risk assessments
for further consideration outside the inspection.

2. How will deficiencies be
categorized?

As with other areas of inspection, deficiencies will be categorized dependent on the significance of the
findings. Typically, complete lack of a system should be classed as a major deficiency, while lesser
deviations within a system would be classed as other. Critical deficiencies may reference QRM where
risk assessments have inappropriately supported release of products that pose a threat to patient safety.
QRM deficiencies may be grouped with other quality systems deficiencies under a quality systems
heading. As always, factual statements of what are seen as deficiencies will be clearly recorded.

3. Should a company have a
procedure to describe how it
approaches QRM related to
manufacture and GMP?

Yes, the procedure should be integrated with the quality system and applied to planned and unplanned
risk assessments. It is an expectation of Chapter 1 that companies embody QRM. The standard
operating procedure (SOP) should define how the management system operates and its general
approach to both planned and unplanned risk management. It should include scope, responsibilities,
controls, approvals, management systems, applicability, and exclusions.

4. Is it acceptable to link QRM
with cost-saving measures?

The expectation of QRM is to assess risks to the medicinal product and patient and manage these to an
acceptable level. It is appropriate for companies to assess their control systems to implement the
optimum controls to ensure product quality and patient safety. If this can be achieved in a more
cost-effective manner while maintaining or reducing risk to the product and patient, then this is
acceptable. However, inappropriate risk assessment and mitigation in order to achieve cost savings is