In collaboration with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – ICH, the FDA has updated the 2006 version of Q9 Quality Risk Management. The update includes various QRM principles and tools that can be used for ensuring and improving quality in the final product.
The update is a part of the routine process where current practices and procedures are updated in response to various factors such as market complaints, feedback from various stakeholders, and, most importantly agency’s standards and operating procedures.
Before finalizing the update, the FDA informs all the relevant stakeholders for their input or feedback and shares the draft of the proposed amendment. Upon receiving the feedback and finalizing the final regulations, the amendment becomes part of the regulations and is enforced accordingly. A copy is also made available for reference purposes through appropriate means such as websites and email.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is an international body that aims to bring regulatory bodies and pharmaceutical organizations worldwide closer to each other. Its main objective is to harmonize pharma procedures, principles, and applications worldwide in different markets.
The ICH is not an enforcing organization and does not have regulations or inspection routines. Instead, all regulation bodies collaborate with it to implement a common strategy for quality in the manufacturing process and final product.
What is Quality Risk Management
Quality Risk Management identifies, evaluates, and removes any risks associated with the pharmaceutical industry's processes, procedures, and products. It helps to prevent defects in the product by minimizing the risk that could degrade the quality of products.
Quality Risk Management defines risk and provides guidelines to identify a risk effectively. It also provides information on controlling and communicating the adverse effect to all interested parties and reviewing risk.
Update on ICH Q9(R1) Quality Risk Management
In the updated Q9 QRM, existing section 5 “risk management methodology” has been updated, and three section called formality, risk-based decision making and subjectivity, are added. Additionally, section 6 “integration of QRM into industry and regulatory operations” has also been updated with one new sub-section “product availability risks”
Let’s briefly discuss each of these updates
Section 5 “RISK MANAGEMENT METHODOLOGY”
In this section three additional sub-section have been added, as mentioned below
Formality in Quality Risk Management
Risk – Based Decision Making
Managing and Minimizing Subjectivity
Let’s briefly discuss each of these sub-sections
Formality in Quality Risk Management
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