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ICH Q10 Technology Transfer and Outsourced Activities Audit Checklist

A comprehensive audit checklist designed to evaluate the effectiveness of technology transfer processes and management of outsourced activities within a pharmaceutical quality system, ensuring compliance with ICH Q10 guidelines and maintaining product quality across different sites and entities.

ICH Q10 Technology Transfer and Outsourced Activities Audit Checklist
by: audit-now
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About This Checklist

The ICH Q10 Technology Transfer and Outsourced Activities Audit Checklist is a crucial tool for pharmaceutical companies navigating the complexities of modern drug development and manufacturing. This checklist focuses on two critical aspects of the ICH Q10 guideline: technology transfer processes and management of outsourced activities. By implementing this checklist, organizations can ensure smooth transitions of products and processes between different sites or entities, and maintain quality control over externally provided services. This approach leads to improved consistency in product quality, reduced risks in supply chain management, and enhanced compliance with regulatory requirements in the global pharmaceutical landscape.

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Industry

Healthcare

Standard

ICH Q10 - Pharmaceutical Quality System

Workspaces

and manufacturing facilities
Pharmaceutical Research Facilities
Development Centers

Occupations

Technology Transfer Manager
Contract Manufacturing Liaison
Quality Assurance Specialist
Process Development Scientist
Supply Chain Manager

1
Is there a quality agreement in place for outsourced activities?

Select the status of the quality agreement.

To ensure that quality expectations are clearly defined and agreed upon.
2
Is the technology transfer documentation complete?

Provide details regarding the documentation status.

To verify that all necessary documentation is available for technology transfer.
3
What is the training completion rate for personnel involved in outsourced activities?

Enter the percentage of training completion.

To assess the preparedness of personnel through adequate training.
Min: 0
Target: 100
Max: 100
4
Is the outsourced activity compliant with regulatory requirements?

Select the compliance status.

To ensure adherence to applicable regulations in outsourced operations.

5
Please provide a description of the outsourced activity.

Enter a detailed description of the activity.

To ensure clarity and understanding of the specific outsourced task.
6
When was the technology transfer completed?

Select the date of completion.

To track the timeline of the technology transfer process.
7
What challenges were identified during the technology transfer process?

Provide a detailed account of challenges faced.

To document any issues that may impact quality and compliance.
8
Was a change control process followed for this outsourced activity?

Select the status of the change control process.

To ensure that any changes are properly managed and documented.

9
How would you rate the performance of the supplier involved in the outsourced activity?

Select the performance rating of the supplier.

To evaluate the supplier's effectiveness and reliability in fulfilling their responsibilities.
10
What is the total number of deviations reported during the outsourced activity?

Enter the number of deviations.

To monitor the frequency of deviations and ensure corrective actions are taken.
Min: 0
Target: 0
Max: 100
11
What corrective actions were taken in response to identified issues?

Provide a summary of corrective actions.

To document the actions implemented to resolve issues and prevent recurrence.
12
When was the last audit conducted on the outsourced activity?

Select the date and time of the last audit.

To ensure regular audits are performed for compliance and quality assurance.

13
Is the outsourced activity compliant with the terms outlined in the contract?

Select the compliance status regarding the contractual terms.

To ensure that all contractual obligations are being met.
14
How many quality control tests were successfully passed during the outsourced process?

Enter the number of quality control tests passed.

To assess the quality assurance measures in place during the outsourced activity.
Min: 0
Target: 0
Max: 1000
15
What were the findings from the risk assessment conducted for this outsourced activity?

Provide detailed findings from the risk assessment.

To document potential risks and their implications on quality and compliance.
16
When was the last compliance review conducted for the outsourced activity?

Select the date of the last compliance review.

To ensure that compliance reviews are conducted at regular intervals.

17
What criteria were used for evaluating the supplier?

List the criteria used for supplier evaluation.

To ensure that the selection of suppliers is based on defined evaluation standards.
18
What is the status of the audit findings related to the outsourced activity?

Select the status of the audit findings.

To track the resolution of issues found during audits.
19
What was the duration of the supplier onboarding process (in days)?

Enter the number of days taken for onboarding.

To evaluate the efficiency of the supplier onboarding process.
Min: 1
Target: 0
Max: 90
20
When is the next scheduled review for the outsourced activity?

Select the date and time of the next review.

To ensure that follow-up reviews are planned and conducted timely.

FAQs

Key elements include a systematic approach for transferring product and process knowledge, risk assessment, validation of the transfer, documentation of the entire process, and training of personnel at the receiving site.

Companies should have a quality agreement with the contract provider, conduct regular audits, clearly define responsibilities, ensure effective communication channels, and maintain oversight of the outsourced activities.

Crucial documentation includes technology transfer protocols, risk assessments, analytical method transfer reports, process validation reports, training records, and any site-specific adaptations of procedures.

By showing documented quality agreements, supplier qualification processes, ongoing supplier performance monitoring, audit reports of contract providers, and evidence of oversight activities.

Knowledge management is crucial for ensuring that all relevant product and process information is captured, transferred, and utilized effectively, both in technology transfers and in managing relationships with contract providers.

Benefits

Ensures robust technology transfer processes are in place and followed

Facilitates effective management and oversight of outsourced activities

Helps maintain product quality and consistency across different manufacturing sites

Supports risk mitigation in supply chain and contract manufacturing

Enhances regulatory compliance in multi-site and collaborative pharmaceutical operations