Overview

Qualification standards are an important part of instrument performance verification programs. To maintain confidence in the accuracy, traceability, and reliability of qualification results, Chemical Solutions™ Qualification Kits are manufactured under controlled conditions and supported by long-term stability testing.

These studies help establish expiration dating practices that support laboratory quality systems while ensuring confidence in the performance of the qualification standards throughout their approved shelf life.

Stability of Qualification Standards

Chemical Solutions™ qualification standards are formulated for long-term stability under recommended storage conditions.

Extensive stability studies have been performed over multiple testing periods to evaluate:

• Standard integrity
• Chemical stability
• Qualification performance
• Concentration consistency
• Long-term usability

The results of these studies support the assigned product shelf life and expiration dating practices used for qualification kits and associated standards.

Expiration Dating

Chemical Solutions™ Qualification Kits, including HSQ™ and PQ™ Kits, are assigned an expiration date of:

Two years from the date of manufacture

This expiration period helps support:

• Quality system compliance
• Product traceability
• Consistent qualification performance
• Laboratory documentation requirements
• Audit readiness

The assigned expiration date is displayed on the product labeling and associated documentation.

Why Expiration Dates Matter

Expiration dating provides laboratories with confidence that qualification standards remain suitable for their intended purpose during the approved shelf-life period.

Proper expiration dating also supports:

• GMP programs
• GLP programs
• Internal SOP requirements
• Instrument qualification procedures
• Quality assurance practices

Documented expiration periods help ensure consistency across qualification programs and regulatory inspections.

Shelf Life at the Time of Shipment

Qualification kits are managed to provide customers with practical usability upon receipt.

Products shipped to customers are supplied with:  A minimum of six months of remaining shelf life

This policy provides laboratories with adequate time to:

• Schedule qualification activities
• Conduct performance verification studies
• Complete annual requalification programs
• Coordinate equipment maintenance schedules
• Manage laboratory inventory effectively

Storage Recommendations

To maximize product stability throughout its approved shelf life, qualification standards should be stored according to product instructions.

Recommended practices include:

• Storing in a cool environment
• Protecting from prolonged light exposure
• Maintaining appropriate storage conditions
• Avoiding unnecessary temperature fluctuations
• Avoiding repeated freeze-thaw cycles when not recommended

Following storage guidelines helps preserve product integrity and qualification performance.

Documentation and Traceability

Qualification kits are supplied with documentation that supports laboratory recordkeeping and traceability requirements.

This documentation assists laboratories with:

• Qualification records
• Audit preparation
• Instrument history files
• Internal quality programs
• Regulatory inspections

Proper record retention should follow each laboratory's quality system requirements.

Key Takeaways

• Chemical Solutions™ Qualification Kits have a two-year expiration period from the date of manufacture.
• Expiration dating is supported by long-term stability studies.
• Products are shipped with a minimum of six months of remaining shelf life.
• Expiration dates support GMP, GLP, and internal quality system requirements.
• Proper storage helps maintain product integrity and qualification performance.
• Documentation supports traceability and audit readiness.

Additional Resources