Pharma Committee Guidelines
ISTA PCG-00 | Catalog Listing & Glossary of Terms
This document has been prepared by the ISTA Pharma Committee, which is composed of both life science manufacturers, wholesalers, and thermal packaging/monitoring suppliers. The terms described are considered by this committee to represent current industry consensus of the definitions for common industry terms that have been used in existing and in-development ISTA Pharma Committee guidance documents.
ISTA PCG-01 | Reusable Passive Thermal Packaging System Best Practice Guideline
This technical white paper discusses the use of reusable passive thermal packaging systems for temperature-controlled distribution of pharmaceutical and biological products. The intent of this information is to establish an aligned industry best practice for the use of reusable packaging to transport temperature-sensitive medicinal products. This white paper provides specific guidance on the types of materials used in passive thermal packaging systems, the qualification of a reusable system, the return logistics and refurbishment service management, and refurbishment and inspection details.
ISTA PCG-02 | Passive Thermal Packaging System Operational Qualification Best Practice Guideline
This technical white paper discusses the operational qualification of passive thermal packaging systems for temperature-controlled distribution of pharmaceutical and biological products. The intent of this information is to establish an aligned industry best practice for the operational qualification testing of passive thermal packaging to transport temperature-sensitive medicinal products.
ISTA PCG-03 | Thermal Shipping System: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline
Developed by members of the ISTA Pharma Committee, this best practice guidance document provides an overview of the performance qualification (PQ) and performance verification (PV) processes for thermal shipping systems used for local and global transport of temperature-sensitive product shipments. The objective of this technical guidance is to establish an aligned industry best practice for the execution of PQ/PV processes following the completion of the thermal operational qualification (OQ). The content and examples provided in this document are to be used for general industry guidance and awareness to drive a standardized best practice approach for the execution of PQ/PV processes.
ISTA PCG-04 | Thermal Packaging System Ambient Temperature Profile (ATP) Best Practice Guideline
Developed by members of the ISTA Pharma Committee, this best practice guidance document was established to align industry best practices for the selection, development and comparison of ATPs for use in the thermal qualification testing of thermal packaging to transport temperature-sensitive medicinal products. This collaborative effort between life science companies and solution providers resulted in a mutually beneficial and harmonized best practices guideline to aid the industry in comparing, investigating and implementing agile compliant solutions.
Pharma Committee Whitepapers
ISTA PCW-01 | Lane Management Whitepaper
The objective of this white paper is to:
- Introduce the concept of Lane Management
- Establish a definition for Lane Management
- Provide an overview of the lifecycle approach to Lane Management
ISTA PCW-02 | Shipping and Distribution Risk Assessment Whitepaper
The objective of this white paper is to provide an aligned industry best practice overview for a shipping and distribution risk assessment as it pertains to the distribution of temperature-sensitive products.
The team sought to define the critical aspects associated with a completing a shipping and distribution risk assessment; from establishing/understanding the user requirement specifications (URS) through implementation.
ISTA PCW-03 | Thermal Modeling Whitepaper
The objective of this white paper is to provide awareness of the tools available for performing thermal modeling and present the current and potential use cases.
The team seeks to clarify what thermal modeling is, and how it could be used to simplify and optimize thermal shipping system understanding and qualification.
This whitepaper is an introduction to thermal modeling and will likely lead to a more detailed technical document in the future.