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ICH Q10 Product Lifecycle Management and Quality Metrics Audit Checklist

A comprehensive audit checklist designed to evaluate the effectiveness of product lifecycle management and the use of quality metrics within a pharmaceutical quality system, ensuring compliance with ICH Q10 guidelines and fostering continuous improvement throughout the product lifecycle.

ICH Q10 Product Lifecycle Management and Quality Metrics Audit Checklist
by: audit-now
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About This Checklist

The ICH Q10 Product Lifecycle Management and Quality Metrics Audit Checklist is an essential tool for pharmaceutical companies committed to maintaining quality throughout a product's lifecycle. This checklist focuses on two critical aspects of the ICH Q10 guideline: product lifecycle management and the use of quality metrics. By implementing this checklist, organizations can ensure that quality considerations are integrated from product development through to discontinuation, and that meaningful metrics are used to drive continuous improvement. This approach leads to enhanced product quality, improved regulatory compliance, and more efficient use of resources across the entire product lifecycle in the pharmaceutical industry.

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Industry

Pharmaceuticals

Standard

ICH Q10

Workspaces

Pharmaceutical development
manufacturing
and quality control facilities

Occupations

Product Lifecycle Manager
Quality Metrics Analyst
Regulatory Affairs Specialist
Manufacturing Excellence Lead
Quality Systems Manager

Product Quality Metrics Assessment

(0 / 4)

1
Please provide a summary of quality metrics reviewed.

Provide a detailed summary of the quality metrics.

To document insights and observations related to quality metrics.
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2
What is the compliance status of the product?

Select the compliance status.

To evaluate whether the product meets regulatory requirements.
3
What is the average yield percentage for this product?

Enter the average yield percentage.

To assess the efficiency of the manufacturing process.
Min: 0
Target: 95
Max: 100
4
What is the name of the product being audited?

Enter the full product name.

To identify the specific product associated with the audit.
5
What mitigation strategies have been implemented?

Provide a detailed description of the mitigation strategies.

To document the actions taken to address identified risks.
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6
What is the priority level of the identified risks?

Select the risk priority level.

To classify the severity of the risks based on their potential impact.
7
How many risks have been identified for this product?

Enter the total number of identified risks.

To quantify the number of potential risks associated with the product.
Min: 0
Target: 5
Max: 100
8
What is the date of the latest risk assessment?

Enter the date of the risk assessment.

To track when the most recent risk evaluation took place.
9
What were the findings from the most recent quality control checks?

Provide a summary of the findings from the quality control checks.

To document observations and actions taken based on quality control results.
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10
What is the compliance status of the quality control checks?

Select the compliance status of the checks.

To evaluate adherence to established quality control protocols.
11
How many quality control checks are performed per batch?

Enter the number of quality control checks for each batch.

To assess the frequency of quality control checks conducted.
Min: 1
Target: 3
Max: 10
12
Who is the owner of the quality control process for this product?

Enter the name of the process owner.

To identify the individual responsible for overseeing quality control.
13
What is the success level of the initiative so far?

Select the success level of the initiative.

To evaluate the effectiveness of the continuous improvement efforts.
14
What are the projected cost savings from this initiative?

Enter the projected cost savings in currency.

To quantify the financial impact of the initiative.
Min: 0
Target: 50000
Max: 1000000
15
What is the start date of the initiative?

Select the start date of the initiative.

To track when the continuous improvement efforts began.
16
What is the title of the continuous improvement initiative?

Enter the title of the initiative.

To identify the specific initiative being evaluated.
17
What is the current compliance status of the product?

Select the current compliance status.

To assess whether the product meets regulatory requirements.
18
How many non-conformities were found during the last audit?

Enter the number of non-conformities found.

To quantify compliance issues identified in the previous audit.
Min: 0
Target: 2
Max: 100
19
When was the last compliance audit conducted?

Select the date of the last compliance audit.

To determine the recency of the compliance evaluation.
20
Which regulatory body oversees the compliance for this product?

Enter the name of the regulatory body.

To identify the governing authority relevant to the product's compliance.

FAQs

The key stages include pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. Quality should be integrated into each stage.

Quality metrics can be used to monitor process performance and product quality, identify trends, drive continuous improvement initiatives, and provide objective evidence of the state of quality to management and regulators.

Common metrics include lot acceptance rate, product quality complaint rate, invalidated out-of-specification rate, CAPA effectiveness, and on-time lot release rate.

By showing documented processes for each lifecycle stage, evidence of knowledge transfer between stages, continuous improvement initiatives, and a system for managing product changes and discontinuations.

Senior management is responsible for ensuring resources are allocated appropriately across the product lifecycle, reviewing quality metrics regularly, and using this information to make strategic decisions about product quality and business performance.

Benefits

Ensures quality integration throughout the product lifecycle

Facilitates data-driven decision making using relevant quality metrics

Helps identify opportunities for continuous improvement across all stages

Supports proactive quality management and risk mitigation

Enhances regulatory compliance and preparedness for inspections