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Pharmaceutical Packaging Facility Audit Checklist

A comprehensive checklist for auditing pharmaceutical packaging facilities to ensure compliance with GMP standards, improve quality control, and enhance operational efficiency.

Pharmaceutical Packaging Facility Audit Checklist
by: audit-now
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About This Checklist

In the highly regulated pharmaceutical industry, ensuring the quality and safety of packaging processes is paramount. This comprehensive Pharmaceutical Packaging Facility Audit Checklist is designed to streamline the auditing process, helping pharmaceutical companies maintain compliance with industry standards and regulations. By addressing critical areas such as equipment maintenance, personnel training, and contamination control, this checklist enables auditors to identify potential risks and improve overall packaging operations. Implementing this checklist can lead to enhanced product quality, reduced compliance risks, and increased operational efficiency in pharmaceutical packaging facilities.

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Industry

Pharmaceuticals

Standard

Good Manufacturing Practice (GMP), 21 CFR Part 211

Workspaces

Packaging facilities

Occupations

Quality Assurance Manager
Packaging Operations Manager
Regulatory Compliance Specialist
Manufacturing Engineer
Pharmaceutical Auditor

Pharmaceutical Packaging Quality Control

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1
Is the training provided to staff adequate for GMP compliance?

Select the level of training adequacy.

To ensure staff are properly trained to maintain compliance.
2
Provide details of the regulatory compliance documentation available for the packaging process.

Describe the documentation.

To verify that all necessary documentation is in place to meet regulatory requirements.
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3
Are quality control checks performed for every batch of packaging?

Indicate if checks are performed.

To ensure quality and safety of the packaged products.
4
What is the percentage of effective contamination control measures implemented?

Enter the percentage of measures implemented.

To assess the effectiveness of contamination prevention strategies.
Min: 0
Target: 100
Max: 100
5
Is the packaging process compliant with GMP standards?

Select compliance status.

To ensure adherence to regulatory requirements and minimize risks.
6
When was the last maintenance performed on the packaging equipment?

Select the date of the last maintenance.

To track the last maintenance activity and ensure it aligns with the scheduled plan.
7
What is the current condition of the packaging equipment?

Select the current condition of the equipment.

To evaluate if the equipment is in a state suitable for operation.
8
Provide details of the last three maintenance activities performed on the equipment.

Describe the maintenance activities.

To verify that maintenance activities are documented and traceable.
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9
How often is the maintenance performed (in days)?

Enter the maintenance frequency.

To assess the regularity of maintenance checks on packaging equipment.
Min: 1
Target: 30
Max: 365
10
Is there a scheduled maintenance plan for packaging equipment?

Indicate if a maintenance plan is in place.

To ensure that equipment is regularly maintained to prevent breakdowns and ensure compliance.
11
When was the last GMP training conducted for packaging personnel?

Select the date of the last training.

To ensure training is current and personnel are up to date with GMP practices.
12
Provide details of any incidents related to personnel practices in the last six months.

Describe any incidents.

To assess the effectiveness of personnel practices and identify areas for improvement.
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13
What percentage of personnel have completed GMP training?

Enter the completion percentage.

To evaluate the effectiveness of training programs on personnel compliance.
Min: 0
Target: 100
Max: 100
14
Are hygiene practices being followed by all personnel in the packaging area?

Select hygiene practices compliance status.

To ensure that proper hygiene measures are maintained to prevent contamination.
15
Are personnel wearing appropriate personal protective equipment during packaging operations?

Indicate if PPE is being used.

To minimize contamination risks and ensure safety compliance.
16
When was the last audit performed on the suppliers?

Select the date of the last supplier audit.

To ensure that supplier audits are conducted regularly and documented.
17
Provide details of supplier performance evaluations conducted in the last year.

Describe the performance evaluations.

To assess the reliability and quality of suppliers over time.
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18
Are all incoming raw materials inspected upon delivery?

Indicate if inspection is performed.

To guarantee that only materials meeting quality standards are used in packaging.
19
How often are suppliers audited (in months)?

Enter the audit frequency in months.

To assess the robustness of supplier management practices and ensure regular evaluations.
Min: 1
Target: 6
Max: 12
20
Are all suppliers compliant with GMP regulations?

Select the compliance status of suppliers.

To ensure that materials sourced from suppliers meet quality and regulatory standards.
21
When was the last validation of the packaging process performed?

Select the date of the last validation.

To ensure that validations are up to date and align with regulatory requirements.
22
Provide a summary of the findings from the validation report.

Describe the findings.

To document and review any issues or observations noted during validation.
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23
How many test runs were conducted during the validation process?

Enter the number of test runs.

To evaluate the thoroughness of the validation activities.
Min: 1
Target: 3
Max: 50
24
What is the current status of the packaging process validation?

Select the validation status.

To assess whether the validation process is ongoing or has been finalized.
25
Has the packaging process validation been completed?

Indicate if the validation is completed.

To ensure that the packaging process meets predefined specifications and quality standards.

FAQs

Pharmaceutical packaging facility audits should typically be conducted at least annually, with some companies opting for more frequent audits (e.g., semi-annually or quarterly) depending on their risk assessment and regulatory requirements.

Key areas covered include equipment maintenance and calibration, personnel training and hygiene, contamination control measures, documentation and record-keeping, material handling and storage, and quality control processes.

These audits are typically conducted by qualified internal auditors, quality assurance personnel, or third-party auditors with expertise in pharmaceutical packaging regulations and Good Manufacturing Practices (GMP).

The checklist helps identify gaps in processes, ensures compliance with regulations, and highlights areas for improvement. This leads to enhanced quality control, reduced risks of product recalls, and improved overall efficiency in packaging operations.

Yes, while this checklist covers general aspects of pharmaceutical packaging audits, it can and should be customized to address specific products, processes, and regulatory requirements relevant to individual facilities.

Benefits

Ensures compliance with GMP and regulatory requirements

Identifies potential risks in packaging processes

Improves quality control and reduces product defects

Enhances operational efficiency and productivity

Facilitates continuous improvement in packaging operations