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ICH Q10 Pharmaceutical Quality System Audit Checklist

A comprehensive audit checklist designed to evaluate compliance with ICH Q10 guidelines and assess the effectiveness of a pharmaceutical quality system in ensuring product quality and patient safety.

ICH Q10 Pharmaceutical Quality System Audit Checklist

by: audit-now
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About This Checklist

The ICH Q10 Pharmaceutical Quality System Audit Checklist is an essential tool for ensuring compliance with international quality standards in the pharmaceutical industry. This comprehensive checklist addresses key elements of the ICH Q10 guideline, focusing on the implementation and effectiveness of a pharmaceutical quality system. By utilizing this checklist, organizations can identify gaps, improve processes, and maintain regulatory compliance, ultimately enhancing product quality and patient safety.

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Industry

Healthcare

Standard

ICH Q10 - Pharmaceutical Quality System

Workspaces

Pharmaceutical manufacturing facilities

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
Pharmaceutical Auditor
Quality Control Analyst
Compliance Officer
1
Is there a documented change control process in place?

Select the compliance status of the change control process.

To ensure that all changes are managed and documented as per regulatory requirements.
2
Please describe the most recent Corrective and Preventive Action (CAPA) taken.

Provide a brief description of the CAPA.

To assess the effectiveness of the CAPA process in improving product quality.
3
What is the frequency of risk management reviews conducted?

Enter the frequency in weeks.

To ensure that risks are regularly assessed and managed.
Min: 1
Target: Quarterly
Max: 52
4
What is the status of the last quality assurance audit?

Select the audit status.

To determine if the quality assurance processes are effective and compliant.
5
When was the last training session conducted for quality assurance personnel?

Select the date of the last training session.

To ensure that staff are adequately trained and up-to-date with current practices.
6
Is the facility in compliance with Good Manufacturing Practices (GMP)?

Select the GMP compliance status.

To assess adherence to GMP standards essential for product quality.
7
What was the defect rate for the last production batch?

Enter the defect rate percentage.

To monitor product quality and identify areas for improvement.
Min: 0
Target: Less than 1%
Max: 100
8
Please provide details of the current continuous improvement plan in place.

Describe the continuous improvement plan.

To evaluate ongoing efforts for enhancing product quality and operational efficiency.
9
What was the outcome of the most recent regulatory inspection?

Select the outcome of the last inspection.

To understand compliance status and any areas requiring attention.
10
Please provide a summary of the key quality metrics tracked over the past quarter.

Summarize the key quality metrics.

To assess the effectiveness of the quality management system and identify trends.
11
How many hours of training have been completed by quality assurance staff in the last year?

Enter the total training hours.

To evaluate the investment in staff development and compliance with training requirements.
Min: 0
Target: Minimum of 20 hours
Max: 100
12
When was the last internal audit conducted for the quality management system?

Select the date of the last internal audit.

To ensure regular evaluations are carried out for compliance and effectiveness.
13
Is the document control system compliant with regulatory requirements?

Select the document control compliance status.

To ensure that all documents are properly controlled and accessible as per compliance standards.
14
What is the average time taken to resolve audit findings in days?

Enter the average resolution time for audit findings.

To evaluate the efficiency of the corrective action processes.
Min: 0
Target: Less than 30 days
Max: 365
15
Please provide a detailed review of the product quality for the last production batch.

Detail the quality review of the last batch.

To assess the quality outcomes and identify areas for improvement.
16
When was the last management review of the quality management system conducted?

Select the date of the last management review.

To ensure that management is actively engaged in the quality management process.
17
Are all suppliers qualified according to the established criteria?

Select the supplier qualification status.

To ensure that all suppliers meet the quality standards necessary for pharmaceutical products.
18
Please provide a summary of all deviations logged in the last quarter.

Summarize the logged deviations.

To assess the frequency and types of deviations occurring and their impact on quality.
19
What percentage of products passed stability testing in the last assessment?

Enter the percentage of products that passed stability testing.

To evaluate product stability and the effectiveness of the formulation.
Min: 0
Target: Minimum of 90%
Max: 100
20
When was the last quality audit conducted?

Select the date of the last quality audit.

To confirm the regularity of quality audits and ensure compliance.

FAQs

The primary purpose is to assess compliance with ICH Q10 guidelines and evaluate the effectiveness of a pharmaceutical company's quality system.

The frequency of ICH Q10 audits may vary, but it is generally recommended to conduct them annually or bi-annually to ensure ongoing compliance and continuous improvement.

The audit team should include quality assurance professionals, subject matter experts, and potentially external auditors with expertise in pharmaceutical quality systems and ICH Q10 requirements.

Key areas include management responsibility, process performance and product quality monitoring, corrective and preventive actions (CAPA), change management, and continuous improvement.

Audit results can identify areas for improvement, guide resource allocation, inform training needs, and drive continuous enhancement of the pharmaceutical quality system.

Benefits of ICH Q10 Pharmaceutical Quality System Audit Checklist

Ensures comprehensive coverage of ICH Q10 requirements

Facilitates consistent and thorough audits across pharmaceutical operations

Helps identify areas for continuous improvement in quality systems

Supports regulatory compliance and reduces risk of non-conformities

Enhances overall product quality and patient safety