Learn about WHO guidelines for Premises and Equipements to successful Technology Transfer in Industrial Pharmacy.
Why Premises and Equipements are important?
Premises and Equipements are vital for technology transfer due to the following reasons:
- Replication: Precise equipment ensures accurate replication of the transferred technology.
- Quality Control: It enables maintaining consistent quality standards during the transfer process.
- Compliance: Precise equipment information ensures adherence to regulatory guidelines and GMP.
- Process Optimization: Detailed equipment data helps identify gaps and optimize the transfer process.
- Troubleshooting and Maintenance: It aids in addressing issues and performing routine maintenance effectively.
In summary, precise equipment information is crucial for successful technology transfer, ensuring replication, quality control, compliance, process optimization, and efficient maintenance.
Premises
The supplier unit (SU) should provide the receiving unit (RU) with essential information regarding building layout, construction, and quality, as well as various services such as Heating, Ventilation, and Air-Conditioning (HVAC), relative humidity, power, water, temperature, and compressed air. These factors significantly impact the product, process, or procedure being transferred.
Additionally, the SU must share important data concerning health, safety, and environmental aspects. Here are the key points:
- Manufacturing risks: The SU should communicate specific hazards associated with the manufacturing methods, such as reactive chemicals, exposure limits, fire risks, and explosion hazards.
- Operator safety measures: The SU needs to provide information on health and safety requirements aimed at reducing operator exposure. For instance, it may include guidelines on controlling atmospheric conditions to prevent the dispersion of pharmaceutical dust.
- Emergency planning: The SU should address emergency planning concerns, including spillage, gas or dust release, fire incidents, and firewater run-off. This involves outlining appropriate protocols and procedures to handle such situations effectively.
- Waste management: The SU must help identify waste streams and outline the requirements for reusing, recycling, and disposing of waste materials. This helps ensure proper waste management practices are implemented.
By providing this simplified and easily understandable information, the SU can help the RU navigate through the crucial aspects of layout, construction, services, health, safety, and environmental considerations.
Equipment
The SU should provide a list of equipment, including brands and models, used in the filling, manufacturing, packing and control of the product or procedure to be transferred. They should also supply the relevant qualification and confirmation documentation.
Important documentation may include drawings, manuals, maintenance logs, calibration logs, and procedures related to equipment setup, operation, cleaning, maintenance, calibration, and storage.
The RU needs to assess the data provided by the SU and compare it with their own inventory list, considering the qualification status (IQ, OQ, and PQ) of each equipment and system. Simultaneously, they should compare the equipment at both sites in terms of functionality, models, and qualification status.
To replicate the transferred process, the RU should conduct a gap analysis. This analysis helps identify the need for modifying existing equipment, procuring new equipment, or making process alterations. It is essential to adhere to Good Manufacturing Practice (GMP) requirements and consider the intended production volumes and batch sizes (such as same scale-up or campaign).
The following factors should be compared between the sites:
- Minimum and maximum capacity of equipment.
- Construction material used in equipment.
- Critical operating parameters of equipment.
- Critical components of equipment (such as filters, screens, temperature/pressure sensors).
- Critical quality attributes of the product.
- Range of intended use for the equipment.
By simplifying the language, we can ensure a clearer understanding of the equipment-related information and the necessary comparisons and analyses required for the successful transfer of the process.
Also read https://pharmasiksha.com/who-guidelines-for-technology-transfer/.