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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?
2
Please describe the most recent Corrective and Preventive Action (CAPA) taken.
3
What is the frequency of risk management reviews conducted?
Min: 1
Target: Quarterly
Max: 52
4
What is the status of the last quality assurance audit?
5
When was the last training session conducted for quality assurance personnel?
6
Is the facility in compliance with Good Manufacturing Practices (GMP)?
7
What was the defect rate for the last production batch?
Min: 0
Target: Less than 1%
Max: 100
8
Please provide details of the current continuous improvement plan in place.
9
What was the outcome of the most recent regulatory inspection?
10
Please provide a summary of the key quality metrics tracked over the past quarter.
11
How many hours of training have been completed by quality assurance staff in the last year?
Min: 0
Target: Minimum of 20 hours
Max: 100
12
When was the last internal audit conducted for the quality management system?
13
Is the document control system compliant with regulatory requirements?
14
What is the average time taken to resolve audit findings in days?
Min: 0
Target: Less than 30 days
Max: 365
15
Please provide a detailed review of the product quality for the last production batch.
16
When was the last management review of the quality management system conducted?
17
Are all suppliers qualified according to the established criteria?
18
Please provide a summary of all deviations logged in the last quarter.
19
What percentage of products passed stability testing in the last assessment?
Min: 0
Target: Minimum of 90%
Max: 100
20
When was the last quality audit conducted?

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