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Good Manufacturing Practice (GMP) Audit Checklist for Pharmaceutical Production

A comprehensive checklist for auditing compliance with Good Manufacturing Practice (GMP) in pharmaceutical production facilities

Good Manufacturing Practice (GMP) Audit Checklist for Pharmaceutical Production
by: audit-now
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About This Checklist

The Good Manufacturing Practice (GMP) Audit Checklist for Pharmaceutical Production is a crucial tool for ensuring compliance with regulatory standards and maintaining product quality in pharmaceutical manufacturing. This comprehensive checklist addresses key aspects of production processes, facility management, and quality control measures as outlined in GMP guidelines. By systematically evaluating your manufacturing practices against GMP requirements, you can identify potential risks, implement necessary improvements, and demonstrate your commitment to producing safe and effective pharmaceutical products. Regular use of this checklist helps maintain consistent quality standards and facilitates continuous improvement in pharmaceutical manufacturing operations.

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Industry

Pharmaceuticals

Standard

Good Manufacturing Practice (GMP)

Workspaces

Pharmaceutical manufacturing facilities
Production areas
Quality control laboratories

Occupations

Quality Assurance Manager
Production Manager
Compliance Officer
Manufacturing Engineer
Quality Control Analyst

Pharmaceutical Production Compliance

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1
When was the last quality review conducted?

Select the date of the last quality review.

To track the frequency of quality reviews in compliance with GMP.
2
What observations were made during quality control testing?

Provide details on any observations.

To document any issues found during quality control checks.
3
What is the quantity of the produced batch?

Enter the batch quantity produced.

To verify that production quantities are within expected limits.
Min: 0
Target: 1000
Max: 10000
4
Is the production process compliant with GMP regulations?

Select the compliance status.

To ensure that production processes meet regulatory standards for quality.
5
When is the next calibration scheduled?

Select the due date for the next calibration.

To ensure timely calibration and compliance with GMP.
6
What is the reference number for the calibration certificate?

Provide the calibration certificate reference number.

To have a traceable identifier for the calibration documentation.
7
What was the date of the last calibration?

Enter the date of the last calibration.

To maintain records for when equipment was last calibrated.
Min: 0
Max: 365
8
Is the equipment properly calibrated?

Select the calibration status of the equipment.

To ensure that the equipment used in production is functioning correctly and providing accurate results.
9
When was the last hygiene audit conducted?

Select the date of the last hygiene audit.

To track the frequency of hygiene audits and ensure compliance.
10
What is the quantity of hand sanitizer available in the production area?

Enter the quantity of hand sanitizer (in liters).

To ensure adequate hand hygiene facilities are available.
Min: 0
Target: 5
Max: 50
11
Have all personnel completed hygiene training?

Provide details on hygiene training completion.

To verify that all staff are trained in hygiene practices to ensure safety.
12
Are personnel using appropriate personal protective equipment (PPE)?

Select the PPE usage status.

To ensure that all personnel are protected and that contamination risks are minimized.
13
When was the last environmental monitoring conducted?

Select the date of the last environmental monitoring.

To track the frequency of environmental monitoring activities to ensure compliance.
14
What measures are in place for humidity control?

Describe the humidity control measures implemented.

To ensure that humidity levels are controlled and do not affect product quality.
15
What is the current temperature range in the production area?

Enter the current temperature (in °C).

To verify that temperature is maintained within specified limits for product safety.
Min: 15
Target: 20-25
Max: 30
16
Is the air quality within acceptable limits in the production area?

Select the air quality status.

To ensure that air quality meets GMP standards to protect product integrity.
17
When was the last review of documents conducted?

Select the date of the last document review.

To ensure that document reviews are conducted regularly to maintain compliance.
18
How many active documents are currently in use?

Enter the number of active documents.

To track the volume of active documentation within the organization.
Min: 1
Target: 50
Max: 500
19
What is the revision history of key documents?

Provide details of the document revision history.

To maintain a clear record of changes made to documents for traceability.
20
Are all documents properly approved before use?

Select the document approval status.

To ensure that all documentation meets regulatory standards and is authorized for use.

FAQs

The checklist covers areas such as facility and equipment maintenance, personnel training, production processes, quality control procedures, and documentation practices.

GMP audits should be conducted regularly, typically at least annually, and also before major changes in production processes or facilities.

The audit team should include quality assurance professionals, production managers, and subject matter experts from relevant departments such as manufacturing, quality control, and engineering.

The checklist helps identify potential issues in manufacturing processes, ensuring that all aspects of production meet GMP standards, thereby maintaining consistent product quality.

Yes, while the core GMP principles remain the same, the checklist can be tailored to address specific requirements of different pharmaceutical products or dosage forms.

Benefits

Ensures comprehensive coverage of GMP requirements in pharmaceutical production

Helps identify and mitigate risks in manufacturing processes

Supports continuous improvement of quality management systems

Facilitates preparation for regulatory inspections

Enhances product quality and patient safety