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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

Healthcare

Standard

Good Manufacturing Practices (GMP)

Workspaces

Pharmaceutical manufacturing facilities
Quality Assurance Areas
Production Areas

Occupations

Quality Assurance Manager
Production Manager
Compliance Officer
Manufacturing Engineer
Quality Control Analyst
1
Is the production process compliant with GMP regulations?
2
What is the quantity of the produced batch?
Min: 0
Target: 1000
Max: 10000
3
What observations were made during quality control testing?
4
When was the last quality review conducted?
5
Is the equipment properly calibrated?
6
What was the date of the last calibration?
Min: 0
Max: 365
7
What is the reference number for the calibration certificate?
8
When is the next calibration scheduled?
9
Are personnel using appropriate personal protective equipment (PPE)?
10
Have all personnel completed hygiene training?
11
What is the quantity of hand sanitizer available in the production area?
Min: 0
Target: 5
Max: 50
12
When was the last hygiene audit conducted?
13
Is the air quality within acceptable limits in the production area?
14
What is the current temperature range in the production area?
Min: 15
Target: 20-25
Max: 30
15
What measures are in place for humidity control?
16
When was the last environmental monitoring conducted?
17
Are all documents properly approved before use?
18
What is the revision history of key documents?
19
How many active documents are currently in use?
Min: 1
Target: 50
Max: 500
20
When was the last review of documents conducted?

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 of Good Manufacturing Practice (GMP) Audit Checklist for Pharmaceutical Production

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