Pre-Inspection Reviews

Filtration is often seen as a critical process in the manufacture of pharmaceutical products, especially if the filter is used towards the end of the production process. Therefore regulatory authorities often review and inspect the equipment, procedures, and documentation associated with users' filtration processes. Pall Life Sciences can assist you in being fully prepared for inspections by both internal and external auditors by offering pre-inspection reviews. This includes a review of the process, procedures, and documentation. Where appropriate, we provide recommendations of additional work required. Typical Pre-Inspection Services Pre-inspection reviews* are carried out by experts in filtration applications who have extensive experience with of applications in pharmaceutical manufacturing operations and are familiar with the key regulatory expectations. The reviewers spend time on-site with operators and managers to assess key areas such as: Technical data Validation data Filter selection Product certification System design Operating procedures Sterilization procedures Integrity testing practice

*The review of filtration processes is a comprehensive technical assessment of these areas. It is the user's responsibility to ensure that all aspects critical to regulatory compliance are assessed in preparation for inspection.

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Features and Benefits

Reviews are carried out by experts in filtration processes to:

• Ensure that users are employing the most suitable filtration system and optimal procedures are employed
• Reduce risk of adverse reports from regulatory inspections
• Give personnel more time to focus on other critical activities

The Pre-inspection review is accompanied by a report containing recommendations for process improvements.

• Ensures that the pharmaceutical manufacturer has time to implement suggested changes prior to regulatory inspection

Support for implementing corrective actions and process improvements.

• Vital help where resources are short or required elsewhere

Review ensures all filters are optimal for each specific application.

• Minimizes operating costs and risk of process failures

Regulatory authorities will expect biopharmaceutical manufacturers to understand the technical specifications of the filters that they use and to be able to justify that each filter is appropriate for the process.

Pall specialists will:

• Document all the filters you use, by part number and application
• Assess whether the filters are suitable for the operation in which they are being used
• Ensure you have key technical data and filter qualification reports available in a form ready for audit

This usually involves a range of process simulation tests involving techniques such as bacterial retention, extractables analysis, active ingredient adsorption etc.

We will advise you of the current filter validation requirements as part of the review, assess your current documentation, and recommend any additional testing.

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Available Pre-Inspection Review Procedures

Validation Data

Regulatory authorities expect that the users of sterilizing-grade filters have assessed and confirmed that:

• The filter does not alter the product adversely
• The product does not affect the filter adversely
• The process conditions do not affect the filter adversely

This usually involves a range of process simulation tests involving techniques such as bacterial retention, extractables analysis, active ingredient adsorption etc. We will advise you of the current filter validation requirements as part of the review, assess your current documentation, and recommend any additional testing.

Product Certification

Where Pall filters are supplied for critical processes they are supported by a manufacturer's certificate of test. Regulatory authorities expect this certificate to be checked before the filter is used and referenced in batch documentation. As part of the pre-inspection review, we will ensure the user understands the data supplied and discuss how it should best be used.

Operating and Sterilization Procedures

Processing limits for critical filters (temperature and pressure, for example) are provided by Pall in its technical documentation. It is necessary to understand how these limits relate to the process in which the filter is being used. This is important to avoid damage to the filter and possible adverse effects on the product being processed. This therefore can form part of a regulatory authority audit.

Our experts will review the types of filters being used, review the processes being operated, and review the documentation supporting the processes. We will then detail any improvements recommended and, if requested, will help with the rewriting of documents such as Standard Operating Procedures.

Integrity Testing Procedures

Integrity testing is a mandatory requirement for critical production filters. Regulatory audits would normally include a review of:

• Integrity test method employed
• Test parameters
• Temperature range
• Integrity test equipment used
• Documentation available to support test instruments

We review all these areas and can recommend possible improvements.

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Charges & Ordering Information

Charges

Wherever possible, we provide a fixed price in advance for the project. Where this is not possible, we will give an estimate to assist you in budgeting and cost control.The final invoice gives details on items such as labor, and materials.

What's the Next Step?

Simply contact your local Pall representatives, or contact Pall at 800-717-7255 or biotech@pall.com.  We will contact you to then discuss your specific requirements and forward your enquiry to Pall technical specialists. We recommend you do this well in advance of a regulatory audit to ensure there is adequate time to review all the key areas and put into place any corrective actions.

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