Introduction
This document provides guidance on the transfer of documents during the activities that take place as a result of the Technology Transfer for approved commercial packaged Drug Product (DP) processes.
It also provides guidance on what documentation needs to be considered as part of the packaging transfer process activities within a GMP site. A list of information to consider as part of the packaging transfer knowledge information package is included in the example. If the documentation received from the sending site is robust and complete, it may allow the receiving site to leverage the qualification and validation strategy from the sending site.
A Packaging technology transfer of an existing DP packaging presentation to a different site often involves a change in registration documentation for the product, to include the new location. Therefore, validation requirements for packaging and support systems at the receiving site should be considered at an early stage of the packaging technology transfer process. The Site Validation Master Plan should also be updated accordingly. Validation requirements for processes, cleaning, analytical methods, and systems (equipment, facilities, utilities etc) should be documented in Site Quality Standards.
Recommendations & Rationale
Once the project transfer team is in place, the success of the transfer process will depend on how effectively and successfully the knowledge and documentation is transferred between the sending and receiving sites. The knowledge information to be transferred will depend in part on the complexity of the process that is being transferred. Refer to following example for a list of the information that is recommended to be compiled by the sending facility during the packaging transfer. The application of the list needs to be conducted on a case by case assessment of the process to be transferred.
Where information suggested in this guidance is not available to provide to the receiving site, an evaluation should be performed to determine the significance of the information gaps. This situation may be more common with older processes. If the information that is not available is considered to be critical to the technology transfer, then it is recommended that the necessary data be generated or obtained. Depending upon the nature of unavailable information, it may be possible for some technology transfer activities to proceed in parallel with the collection or generation of the unavailable information. If the information is determined to not be critical, then the technology transfer may be able to proceed without obtaining it.
When only the packaging process is transferred, the documentation from the sending site should be focused mostly on product quality documentation and product history. When the packaging equipment is also included as part of the transfer, the documentation to be transferred will include equipment documentation such as calibration, qualification, cleaning certificates, SOPs, maintenance logs, etc.
The documentation received will be used to define the qualification and validation strategy to be followed by applying a scientific risked-based approach. As an example of how important it is to receive a complete package, refer to the following example:
Example:
Transfer of Product “A”, complete packaging line and associated documentation between two sites. The receiving site should have previous experience as a packaging site of a similar process.
1. Documentation Requirements:
The sending site:
The sending site will provide the following equipment documentation as available:
- System Level Impact Assessments (SLIA)
- Component Level Impact Assessments (CLIA)
- System Level Commissioning Plan (SLCP)
- Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ)
- Calibration documentation and history
- Preventative maintenance documentation and history
- System specific training materials
- Cleaning procedures and certificates
- Specifications, equipment manuals and drawings
- Standard Operating Procedures (SOPs) for operation, cleaning, maintenance, and support.
The receiving site:
Perform a gap and risk assessment of the equipment and process to be transferred using the documentation received from the sending site. The site evaluates the risks involved in the packaging technology transfer and develops a plan to address the gaps.
Review the System and Component Level Impact assessments from the sending site and system classification. Determine whether or not new impact assessments should be performed or use the sending site assessments as part of the qualification efforts.
If the equipment is re-classified, refer to validation guidance for qualification requirements according to equipment classification.
Evaluate if the qualification documentation provided by the sending site will meet site requirements. If not, the receiving site can develop a plan to address the missing information. If documentation is acceptable then evaluate if any additional testing is required from an operation range stand point. If an operational range needs to be extended then OQ testing will be required. If the product and process requirements are satisfied no additional OQ testing is required.
2. Validation Strategy should be as follows:
Receiving site should define the validation approach to be used in a Validation Project Plan or Project Commissioning and Qualification Plan (PCQP).
Install equipment and perform equipment commissioning activities and installation qualification (IQ) if assessment has defined the system as direct impact.
For direct impact systems, if the previously executed OQ documentation meets receiving site requirements and the equipment will be operated at the same speeds and parameters that were previously qualified, no additional packaging equipment OQ testing will be required or the receiving site may require only a simple check to verify the operation of the relocated equipment. Previously executed OQ testing will support the required operational ranges at the receiving site.
The PQ study will challenge the operational ranges obtained from the sending site qualification package (OQ or PQ).
In addition, the following considerations are assessed to determine the PQ requirements of the relocated equipment:
- The criticality of the transferred packaging step (s) (dosage form, primary or secondary packaging).
- Whether there has been a change in packaging materials.
- The availability of adequate existing documentation from the transferring site to demonstrate the performance of the equipment.
- Successful operation verification after relocation.