Seeking Industry Peer Review of OQ Guideline


ISTA Pharma Committee Passive Thermal Packaging System OQ Best Practice Guideline


The ISTA Pharma Committee is seeking industry peer review on our latest technical paper "Passive Thermal Packaging System Operational Qualification Best Practice Guideline". The committee's goal was to develop a guideline for the passive thermal packaging operational qualification process that defines the minimum requirements and drives standardization among packaging providers and life science companies alike. The guideline is a result of a collaborative effort between life science companies and solution suppliers tasked with developing a set of mutually beneficial and harmonized requirements. We believe there are many benefits of this guideline including:

  • Simplifying the process for life science companies of comparing solutions on the market

  • Ensuring "off-the-shelf" solutions meet life science company's testing and quality expectations.

  • Standardize the expectations from life science companies enabling solution providers to further innovate.

  • Streamline the operational qualification and review process for solution partners.

We recognized that there are other guideline documents available in the industry. The ISTA Pharma Committee aims to provide users with a how to guide to achieve success on important industry topics while allowing users to work within their own internal procedures. We believe the level of detail beyond the suggested industry best practice is the decision of the primary stakeholders of the temperature-sensitive product and based on each organization's risk acceptance.

  • To provide your comments, please click here to access the document and comment form. We are seeking feedback on specific items that your organization cannot comply with (and why), any missing details and/or content that needs further clarification. We ask that you refrain from providing feedback around grammar and formatting.

  • The deadline for comments has been extended to Friday, May 8th, 2020.

For any questions, please email us at ista@ista.org or call us at (517) 333-3437.


Regards,
The ISTA Pharma Committee