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GMP Compliance Audit Checklist for Pharmaceutical Manufacturing

A comprehensive checklist for auditing GMP compliance in pharmaceutical manufacturing facilities, covering all aspects of GMP requirements to ensure product quality, safety, and regulatory compliance.

GMP Compliance Audit Checklist for Pharmaceutical Manufacturing
by: audit-now
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About This Checklist

In the highly regulated pharmaceutical industry, ensuring compliance with Good Manufacturing Practice (GMP) standards is crucial for maintaining product quality, safety, and efficacy. This comprehensive GMP Compliance Audit Checklist for Pharmaceutical Manufacturing is an essential tool for auditors, quality assurance professionals, and regulatory affairs specialists. It helps identify potential gaps in GMP compliance, mitigate risks, and maintain the highest standards of pharmaceutical production. By systematically addressing key areas of GMP requirements, this checklist streamlines the audit process, enhances regulatory compliance, and ultimately contributes to patient safety and product integrity.

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Industry

Pharmaceuticals

Standard

Good Manufacturing Practice (GMP)

Workspaces

Pharmaceutical Manufacturing Facility

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
GMP Auditor
Compliance Officer
Production Manager

GMP Compliance Questions

(0 / 4)

1
Are all Standard Operating Procedures (SOPs) being followed?

Select adherence status

Adherence to SOPs is essential for maintaining compliance with GMP.
2
Is all equipment calibrated according to GMP standards?

Select whether equipment is calibrated

Proper calibration is necessary to ensure accurate measurements and product quality.
3
How many quality control samples were tested in the last month?

Enter the number of samples tested

Testing samples is crucial for ensuring product quality and safety.
Min: 0
Target: 0
Max: 1000
4
Are all employees trained in GMP standards?

Select compliance status

Training ensures that employees understand and comply with GMP regulations.
5
What is the average time taken to implement Corrective and Preventive Actions (CAPA)?

Enter the average time in days

Timely implementation of CAPA is essential for addressing compliance issues.
Min: 0
Target: 0
Max: 365
6
When was the last internal audit conducted?

Select the date of the last internal audit

Regular internal audits are necessary to assess compliance with GMP.
7
Please provide details of any deviation reports reviewed in the last month.

Enter details of deviation reports

Reviewing deviation reports helps identify non-conformances and corrective actions.
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8
Are all batch records complete and accurately filled out?

Select batch record completeness status

Complete batch records are critical for traceability and compliance with GMP.
9
Provide details on the last maintenance records reviewed for equipment.

Enter details of maintenance records

Regular maintenance ensures equipment reliability and compliance with GMP.
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10
How frequently is the temperature monitored in the storage area?

Enter frequency in hours

Regular temperature monitoring is essential to ensure product stability and safety.
Min: 0
Target: 0
Max: 24
11
Is access to the production area controlled and limited to authorized personnel?

Select whether access is controlled

Controlled access minimizes the risk of contamination and unauthorized activities.
12
Is the production area maintained in a clean and sanitary condition?

Select cleanliness status

A clean production area is vital to prevent contamination and ensure product quality.
13
Provide a summary of the latest supplier quality audit results.

Enter supplier audit summary

Evaluating supplier quality helps maintain the integrity of materials used in production.
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14
Are materials stored under appropriate conditions as per GMP requirements?

Select whether storage conditions are appropriate

Proper storage conditions prevent material degradation and ensure safety.
15
What is the percentage accuracy of the material inventory?

Enter percentage accuracy

Accurate inventory is crucial for ensuring the right materials are available for production.
Min: 0
Target: 100
Max: 100
16
Are all incoming materials accompanied by the appropriate documentation?

Select documentation status

Proper documentation ensures traceability and compliance with GMP during material receipt.
17
Provide details on the last review of the emergency response plan.

Enter emergency response plan review details

Regular reviews of the emergency response plan ensure preparedness for unforeseen events.
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18
Have mitigation strategies for identified risks been implemented?

Select whether mitigation strategies are implemented

Implementing strategies is necessary to minimize the impact of risks on production.
19
How many risks have been identified in the current risk management plan?

Enter the number of identified risks

Identifying risks is crucial for developing effective mitigation strategies.
Min: 0
Target: 0
Max: 100
20
Have all relevant risk assessments been completed for the production processes?

Select risk assessment status

Completing risk assessments is essential for identifying and mitigating potential hazards.

FAQs

By regularly using this checklist, pharmaceutical companies can identify and address potential GMP compliance issues proactively, ensuring better preparedness for regulatory inspections.

Yes, while the checklist covers general GMP requirements, it can be tailored to include specific items relevant to particular manufacturing processes or dosage forms.

This checklist is designed for use by quality assurance managers, regulatory affairs specialists, internal auditors, and external GMP consultants in the pharmaceutical industry.

GMP compliance audits should be conducted at least annually, with more frequent audits recommended for high-risk areas or in preparation for regulatory inspections.

The checklist covers essential GMP areas including personnel training, facility and equipment management, documentation practices, production processes, quality control, and product release procedures.

Benefits

Ensures comprehensive coverage of GMP requirements in pharmaceutical manufacturing

Facilitates consistent and standardized auditing processes across facilities

Helps identify and address potential compliance gaps before regulatory inspections

Promotes continuous improvement in quality management systems

Supports documentation and traceability of GMP compliance efforts