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Pharmaceutical Raw Material Inspection and Testing Audit Checklist

A comprehensive checklist for auditing raw material inspection and testing processes in pharmaceutical manufacturing to ensure product quality, regulatory compliance, and supply chain integrity.

Pharmaceutical Raw Material Inspection and Testing Audit Checklist
by: audit-now
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About This Checklist

Ensuring the quality and safety of raw materials is fundamental to pharmaceutical manufacturing. This Pharmaceutical Raw Material Inspection and Testing Audit Checklist is a critical tool for evaluating the robustness of raw material quality control processes. By systematically assessing supplier qualification, material receipt procedures, sampling methods, analytical testing, and documentation practices, this checklist helps maintain compliance with regulatory standards and safeguards product quality from the earliest stages of production. Regular implementation of this comprehensive audit process can significantly reduce the risk of contamination, enhance consistency in finished products, and support overall quality assurance in pharmaceutical manufacturing.

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Industry

Pharmaceuticals

Standard

ICH Q7, FDA 21 CFR Part 211

Workspaces

Research laboratories

Occupations

Quality Assurance Specialist
Raw Material Quality Control Manager
Procurement Specialist
Analytical Chemist
Supply Chain Manager

Raw Material Inspection and Testing

(0 / 12)

1
Please detail any corrective actions taken based on previous inspections.

Provide details about corrective actions implemented.

To document the effectiveness of corrective actions and ensure continuous improvement.
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2
When is the next scheduled quality review for these raw materials?

Enter the date for the next quality review.

To ensure that regular reviews are conducted to maintain quality standards.
3
What is the moisture content percentage of the raw material?

Enter the moisture content percentage.

To verify that the moisture content is within acceptable limits for quality control.
Min: 0
Target: 5
Max: 15
4
Is the packaging of the raw materials intact and undamaged?

Assess the condition of raw material packaging.

To ensure that the integrity of raw materials is maintained and that contamination is prevented.
5
Please summarize the findings from the previous raw material inspection.

Provide a summary of the previous inspection findings.

To maintain a record of past findings and assess if past issues have been resolved.
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6
What is the quantity of raw material received (in kg)?

Enter the quantity received in kilograms.

To ensure that the quantity received matches the purchase order and is within acceptable limits.
Min: 0
Target: N/A
Max: 10000
7
Is the testing equipment calibrated and within the valid calibration period?

Evaluate the calibration status of testing equipment.

To ensure that testing equipment provides accurate results essential for quality control.
8
Is the identification of the raw material verified against the specifications?

Confirm if the identification has been verified.

To confirm that the correct raw materials are being used and that they meet specified requirements.
9
Please describe the analytical methods used for raw material testing.

Provide a detailed description of the analytical methods.

To ensure that appropriate analytical methods are being applied for testing raw materials.
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10
Is the supplier of the raw materials qualified according to GMP standards?

Assess the qualification status of the supplier.

To ensure compliance with regulatory standards and supplier reliability.
11
What percentage of raw materials passed the quality testing?

Enter the percentage of materials that passed quality testing.

To assess the effectiveness of the quality control measures in place.
Min: 0
Target: 100
Max: 100
12
Is the Certificate of Analysis (CoA) for the raw materials available and valid?

Check the availability and validity of the CoA.

To ensure that all raw materials have been tested and meet the required specifications.

FAQs

Raw material audits should be conducted at least annually for critical suppliers, and more frequently for new suppliers or those with a history of quality issues. Additionally, spot audits may be performed based on risk assessment.

This checklist covers supplier qualification processes, material receipt and quarantine procedures, sampling methods, analytical testing protocols, certificate of analysis verification, and documentation practices for raw material quality control.

These audits are typically conducted by quality assurance specialists, raw material quality control managers, or procurement specialists with expertise in pharmaceutical quality requirements.

The checklist ensures that all aspects of raw material quality control meet regulatory standards, including supplier qualification, material testing, and documentation, which are crucial for compliance with GMP and other industry regulations.

If a raw material fails inspection or testing, actions should include immediate quarantine of the material, investigation of the root cause, supplier notification and corrective action request, evaluation of impact on existing inventory and products, and consideration of alternative suppliers if necessary. All actions must be thoroughly documented.

Benefits

Ensures compliance with GMP and regulatory requirements for raw material quality control

Reduces risks of product contamination and recalls due to substandard raw materials

Improves consistency and reliability of finished pharmaceutical products

Enhances supplier management and qualification processes

Facilitates early detection of potential quality issues in the supply chain