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level: Level 3

Questions and Answers List

level questions: Level 3

Question	Answer
This annex is intended to identify potential uses of quality risk management principles and tools by industry and regulators.	ANNEX II: POTENTIAL APPLICATIONS FOR QUALITY RISK MANAGEMENT
To review current interpretations and application of regulatory expectations; To determine the desirability of and/or develop the content for SOPs, guidelines, etc.	QUALITY RISK MANAGEMENT AS PART OF INTEGRATED QUALITY MANAGEMENT DOCUMENTATION
QUALITY RISK MANAGEMENT AS PART OF INTEGRATED QUALITY MANAGEMENT components:	1 Documentation 2 Training and education 3 Quality defects 4 Auditing/Inspection 5 Periodic review 6 Change management / change control 7 Continual improvement
To determine the appropriateness of initial and/or ongoing training sessions based on education, experience and working habits of staff, as well as on a periodic assessment of previous training (e.g., its effectiveness); To identify the training, experience, qualifications and physical abilities that allow personnel to perform an operation reliably and with no adverse impact on the quality of the product.	Quality Risk Management as Part of Integrated Quality Management: Training and education
To provide the basis for identifying, evaluating, and communicating the potential quality impact of a suspected quality defect, complaint, trend, deviation, investigation, out of specification result, etc; To facilitate risk communications and determine appropriate action to address significant product defects, in conjunction with regulatory authorities (e.g., recall).	Quality Risk Management as Part of Integrated Quality Management: QUALITY DEFECTS
To define the frequency and scope of audits, both internal and external, taking into account factors such as:  Existing legal requirements;  Overall compliance status and history of the company or facility;  Robustness of a company’s quality risk management activities;  Complexity of the site;  Complexity of the manufacturing process;  Complexity of the product and its therapeutic significance;  Number and significance of quality defects (e.g., recall);  Results of previous audits/inspections;  Major changes of building, equipment, processes, key personnel;  Experience with manufacturing of a product (e.g., frequency, volume, number of batches);	Quality Risk Management as Part of Integrated Quality Management: AUDITING/INSPECTION
- Select, evaluate, and interpret trend results of data within the product quality review; - Interpret monitoring data.	Quality Risk Management as Part of Integrated Quality Management: PERIODIC REVIEW
Manage changes based on knowledge and information during pharmaceutical development and manufacturing; Evaluate the impact of the changes on the availability of the final product; Evaluate the impact on product quality of changes to the facility, equipment, material, manufacturing process or technical transfers; Determine appropriate actions preceding the implementation of a change, e.g., additional testing, (re)qualification, (re)validation or communication with regulators	Quality Risk Management as Part of Integrated Quality Management: CHANGE MANAGEMENT / CONTROL
Facilitate continual improvement in processes throughout the product lifecycle.	Quality Risk Management as Part of Integrated Quality Management: CONTINUAL IMPROVEMENT