Technology Transfer: Documentation, Premises & Equipment

Documentation for Technology Transfer:

The table includes key tasks, the documentation provided by the supplier (SU), and the transfer documentation required:

Please note that these are general examples, and the specific documentation requirements may vary depending on the nature of the technology transfer and regulatory requirements in your region. Always refer to the latest WHO guidelines or local regulatory authorities for precise documentation requirements.

 

Key Task	Documentation Provided by SU	Transfer Documentation Required
Technology Assessment	- Technology feasibility report	- Technology assessment report
	- Equipment specifications and drawings	- Equipment specifications
	- Process flow diagrams	- Process flow diagrams
	- Raw material specifications	- Raw material specifications
	- List of critical quality attributes (CQAs) and parameters	- List of CQAs and parameters
	- Analytical methods and validation data	- Analytical methods
Technology Transfer Plan	- Detailed technology transfer plan	- Approved technology transfer plan
	- Project timeline	- Project timeline
	- Roles and responsibilities of both parties	- Roles and responsibilities
	- Risk assessment and mitigation plan	- Risk assessment plan
Documentation Review	- Drafts of standard operating procedures (SOPs)	- Reviewed and approved SOPs
	- Quality control and quality assurance documents	- Reviewed and approved QA/QC documents
	- Validation protocols and reports	- Reviewed and approved validation documents
	- Regulatory submission documents (if applicable)	- Reviewed and approved regulatory submission documents (if applicable)
Training	- Training materials	- Training records
	- Training program	- Training program
	- Training assessments	- Completed training assessments
Manufacturing Transfer	- Manufacturing process documentation	- Verified manufacturing process documentation
	- Equipment qualification and validation records	- Verified equipment qualification and validation records
	- Batch records	- Verified batch records
	- In-process and release testing methods and results	- Verified testing methods and results
Quality Assurance and Control Procedures	- Quality control procedures	- Approved quality control procedures
	- Quality assurance procedures	- Approved quality assurance procedures
	- Change control procedures	- Approved change control procedures
Validation and Qualification Activities	- Validation protocols and reports	- Approved validation protocols and reports
	- Qualification protocols and reports	- Approved qualification protocols and reports
Continuous Monitoring and Evaluation	- Ongoing process performance data	- Ongoing process performance data
	- Periodic quality review reports	- Periodic quality review reports
Regulatory Submission (if applicable)	- Dossier or regulatory submission documents	- Verified dossier or regulatory submission documents (if applicable)

 Premises

• Layout and Building Information: The Supplier (SU) is responsible for furnishing comprehensive details to the Receiving Unit (RU) regarding the layout, construction, and finish of buildings and services. These services encompass critical factors such as heating, ventilation, and air-conditioning (HVAC), temperature control, relative humidity management, water supply, power systems, and compressed air. This information is vital, as it directly influences the product, process, or methodology intended for transfer.
• Health, Safety, and Environmental Data: The Supplier (SU) is also obligated to provide information regarding pertinent health, safety, and environmental aspects. This encompasses:
• Identifying inherent risks associated with manufacturing processes, including potential hazards such as reactive chemical substances, exposure limits, as well as fire and explosion risks.
• Specifying health and safety prerequisites aimed at minimizing operator exposure, including measures for atmospheric containment of pharmaceutical dust.
• Addressing emergency planning considerations, such as protocols to be followed in the event of gas or dust release, spillage, fire incidents, and management of firewater run-off.
• Identifying waste streams and outlining provisions for potential re-use, recycling, or disposal of waste materials.

Equipment

• Equipment List and Documentation: The Supplier (SU) is responsible for supplying an exhaustive list of equipment, including makes and models, utilized in the manufacture, filling, packing, or control of the product, process, or methodology slated for transfer. This list should be accompanied by all relevant qualification and validation documentation. Such documentation might encompass drawings, user manuals, maintenance logs, calibration records, and standard operating procedures pertaining to equipment setup, operation, cleaning, maintenance, calibration, and storage.
• Equipment Comparison: The Receiving Unit (RU) must carefully review the information provided by the Supplier (SU) in conjunction with its own inventory list, which should include equipment qualification statuses (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)). A side-by-side comparison of equipment at both sites should be conducted, considering functionality, makes, models, and qualification statuses.
• Gap Analysis: The Receiving Unit (RU) must undertake a gap analysis to discern any requisites for adapting existing equipment, procuring new equipment, or modifying the process to enable accurate replication of the transferred process. This analysis must satisfy Good Manufacturing Practices (GMP) requirements and account for intended production volumes and batch sizes, whether they remain the same, scale up, or involve campaign production. Factors to be assessed include minimum and maximum capacity, material composition, critical operating parameters, vital equipment components (e.g., filters, screens, and temperature/pressure sensors), critical quality attributes, and the range of intended use.
• Equipment Location Mapping: The specific locations of equipment within the facility and buildings at the Receiving Unit (RU) should be meticulously considered when creating process maps or flowcharts for the transferred manufacturing process. This evaluation should also encompass the flow of personnel and materials.
• Impact on Existing Products: The impact of introducing the manufacturing of new products on items currently produced with the same equipment must be assessed and documented.
• Modification Documentation: Any modifications required to adapt existing equipment to replicate the transferred process should be comprehensively documented in the transfer project plan.