Performance Qualification (PQ) Study Services

Performance Qualification is a transportation study with product or representative product that is conducted during the actual transportation or distribution of a representative supply chain to ensure the robustness of temperature control and package integrity of shipping systems. These studies are designed to track real world shipments across the active supply chain or worst case expected supply chain while assessing thermal and physical performance as well as outbound/inbound shipping processes.

PQ Bracketing Approach

Pre-approved PQ protocol should document packaging material information (primary, secondary and tertiary) such as specification, item numbers, and lot numbers. Sound rationale to justify the test methods and variables used must be documented in the protocol. Bracketing approach (multiple shipping/receiving site(s), payload sizes, etc.) can be used to leverage and minimize testing while qualifying similarly packaged products or distribution zones under a PQ study. PQ testing should be conducted concurrent with actual shipping and transportation processes within the intended supply chain. When evaluating a bracket approach, the following attributes should be considered:  

  • Supply Chain Nodes (Origin/destination sites)
  • Shipping Distance
  • Shipping Duration
  • Minimum and Maximum product load (mass, volume)
  • Ambient Temperatures of Shipping Lanes (including seasonal temperature variations) 

PQ Acceptance Criteria

As part of a PQ study, specific testing requirements and acceptance criteria will be defined in a pre-approved protocol and based on relevant SOPs and regulatory guidance. At minimum, acceptance criteria should comprise of the following:

  1. Temperature Monitoring per product specification
  2. Package Integrity Testing
  3. Confirmation of shipping process

Note: At times, For certain instances, market-specific requirements or regulatory feedback may dictate additional protocol acceptance criteria, such as container closure integrity testing (CCIT), product quality attribute testing and/or functionality testing.

The PQ acceptance criteria are to include the following requirements:

Temperature Monitoring:

  • Temperature monitoring to provide evidence that the product/packaging system can maintain required temperature (per product specification) for the duration of transport.  
  • Calibrated electronic temperature monitors that are downloaded and offer the ability to assess the temperatures throughout the shipment to provide additional visibility into the shipment performance and assist in deviation evaluation. PQ testing requires temperature monitoring devices with locations to be used during testing and documented at the time of execution. A minimum of one calibrated temperature monitor is to be placed within the payload; the quantity and location is to match normal operations as defined in previous qualifications or SOPs. 
  • The ambient temperatures are not part of the acceptance criteria. The use of temperature monitors at the external location of the shipping system is optional but recommended. Collection of ambient temperatures can provide confirmation that the route conditions were within the range tested in previous qualifications.

Package Integrity Testing:

  • Upon the receipt, PQ test required to perform, minimally, visual inspection for primary, secondary, tertiary packaging, and ancillary component packaging as part of the package integrity testing.
  • Package Integrity testing may be assessed according to Acceptable Quality Limits (AQLs), Limiting Quality, Inspection, and Sampling plan. 
  • Shipping and Handling defects are to be classified according to their severity and impact on product using classifications, such as minor, major, and critical. 
  • Post-transport shipment samples may go though the container closure integrity testing (CCIT), product quality attribute testing and functionality testing to determine impact to product safety and efficacy when exposed to the representative shipping process. These tests are optional.

PQ Execution

PQ testing should utilize representative product and representative product payload.  If active product is not used, a comparability assessment is required between the product and simulated product payload. WHO guidance suggests capturing seasonal variation when possible. The execution of the PQ run(s) during the worst-case seasonal time periods is advisable when using shipping systems that have seasonal packout configurations (e.g., summer packout configuration is tested in the summer season). It is suggested to have a minimum of one PQ shipment (i.e., run), which can cover single or multiple routes, depending on the scope of the PQ. If multiple shipping sites and/or receiving sites are in the scope of a PQ, not all sites may need to participate in the execution of a shipment based on risk assessment. Protocol execution special instructions and training shall be provided prior to PQ execution. 

Lean Biologix has vast experience with regulatory requirements, industry standards and best practices to support all aspects of shipping qualification. We help our clients with performance qualification activities, such as gathering User Requirement Specifications (URS), documentation of PQ protocol and report, and providing required justification and risk assessment for bracket-based approaches and shipping lane assessments, etc. Once the documentation is as per client and regulatory standards, we help clients with necessary PQ protocol training and execution. 

LBX can develop, evaluate, execute, and summarize the PQ testing for a customer’s review while being compliant with the current industry and regulatory standards. We have a standardized process for managing shipping qualification programs that has been proven successful with regulatory agencies and eliminates “re-inventing the wheel” when developing or qualifying additional assets within a client’s portfolio. LBX has a proven track record of developing and executing supply chain PQ qualification programs for domestic and international supply chain lanes.

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