Russian Good Distribution Practices Pharmaceutical Regulations, Part 3

After looking at the general key elements of Russian Good Distribution Practices in Part 1, of our series and the storage requirements in Part 2, let’s now look at the transportation and other in-transit related elements.

These are the top Russian GDP regulation highlights our experts believe are important to meet:

• The supply chain must be mapped to determine where medicinal products’ quality and/or integrity could be at risk – develop a risk assessment.
• Risk mitigation measures must be implemented and documented. Determine how to combat your risks and minimize them.
• Standard Operating Procedures (SOPs) have to be documented and followed, which means develop the day-to-day process for all parties involved.
• Personnel managing or handling medicinal products should be trained on relevant SOPs and how to deal with temperature and humidity deviations.
• There should be verification points for product integrity and quality (e.g., check of packaging, confirming number of doses, reading temperature and humidity recordings, etc.) at key risk areas in the supply chain.
• Outsourced activities to third parties must be defined, officially contracted and assessed.
• Suppliers and customers must be assessed and audited against risk for product quality and integrity. A company’s legitimacy to meet stated quality and SOP agreements with such products should be documented. They must demonstrate the ability to follow Russian GDP guidelines.
• Supply chain professionals must demonstrate that product quality, integrity and authenticity have not been compromised at any point of the transportation/distribution.
• Deviations in terms of environmental conditions (temperature, humidity) or integrity must be investigated and documented.
• Equipment used to transport thermal sensitive products must be fit for use and perform as intended when designed and operational. This means the equipment should be qualified prior to use, and the qualification must be repeated based on risk assessments. More information on Qualification can be found in the following article: Qualification vs Validation . The instruments used to measure the environmental conditions must be calibrated in conformance with Russian Metrology requirements. More information on this topic will be provided in the fourth of our Russian regulations series, “Requirements for Calibration and Metrology.”
• Packaging used for transportation of medicinal products should guarantee safeguarding of quality and integrity conditions.
• Storage and transport conditions must be visible on shipping labels.
• Qualification of equipment and storage areas must be conducted prior to use to demonstrate the first requirement. This applies but is not limited to warehouse, refrigerators, freezers, and cold chambers. This requirement can best be described in the Pharmaceutical Outsourcing article: Model for Qualification of Shipping Systems for Temperature Sensitive Pharma Products.
• Qualifications must be re-conducted at regular intervals or based on risk assessments. These assessments are necessary because often times there can be changes in storage areas and operations based on HVAC and temperature zone changes. An example of this might be product that is stored near the doors that indicates higher temperatures versus product near ample ventilation sources.
• The results of the qualification must be used in the positioning of permanent environmental and/or security monitoring systems at the most critical points where temperature excursions are likely to occur.
• The facility and equipment monitoring system must be able to monitor the health of the facility and storage areas, and send alerts about alarms (humidity, open/close doors, outages, pressure, etc.) to key responsible persons and be able to escalate when appropriate.
• Measuring equipment must be calibrated to a recognized metrology standard annually. In Russia, the environmental condition monitoring instruments must have an official Russian Certificate of Metrology. This will be explained in detail in a future Sensitech blog article, but for now what is important to remember is that regular annual calibrations must be conducted and an audit trail accurately records under this metrology standard.
• Processes must be put into place to ensure product safety & integrity. Some examples of this might be to initiate programs or standards to prevent against cross-contamination, pests, and theft.
• All risk assessments must be documented and be readily available in case of inspection.
• Standard Operating Procedures must be documented and followed regarding receipt of inbound shipments or outbound shipments to and from the facility.

It’s All About the Data

As we discussed in part one of this series, there is a strong focus on risk management, control, and mitigation. Several risk assessments are required such as a qualification/mapping of storage and transportation equipment, however, with stricter language than in other international guidance documents, the Russian regulations use language such as “must” vs. “should.”

Global regulations are becoming increasingly strict and with greater enforcement increasing the need for good cold chain management practices for pharmaceutical product storage. Thankfully, there are cloud-based validated solutions, analytics to support continuous improvement programs, and compliant technology available to help meet those requirements.

In order to meet this stringent criteria there are three goals you should consider when implementing a facility monitoring system:

• Meet high operational efficiency goals
• Meet regulatory compliance requirements
• Be able to document and demonstrate control and visibility

Companies will need to evaluate compliant systems that best fit their operational and business needs. This stationary monitoring system checklist can help:

Temperature monitoring system checklist

• Flexible, hands-free sensor network that supports both large and small environments
• Easy-to-use, non-disruptive deployment
• Cost-effective, automated record keeping
• Secure record management through centralized data administration
• Global access to information where and when it's needed
• Real-time alarming and alerting
• Improved visibility and compliance through online data history and audit trail

Sensitech Professional Services conducts shipping performance studies to evaluate if a company’s specific distribution processes maintain the proper temperature as per design specifications and requirements in an actual distribution environment. It is important to understand where the risks are by:

• Route
• Pack-out
• Product or product groups
• Packaging
• Transport mode
• Appropriate logistics shipping service level

Sensitech works closely with companies helping customers manage and improve their cold chain performance, with real monitoring data to help meet stringent global regulations and ensure consistent quality throughout the temperature-sensitive supply chain. By utilizing a six-step methodology to cold chain analysis, Sensitech Professional Services can identify weaknesses before they become systemic problems.

Reducing risk, quarantine time and product loss while increasing efficiencies is paramount for life sciences companies. ColdStream^® Select is a global risk-mitigation, cloud-based solution that can help protect validated data for in-transit product release decisions critical to product integrity and patient safety for ongoing shipments. Learn more about:

• Optimizing protection of temperature-sensitive, life sciences products
• Meeting regulatory compliance and providing defensible audit support
• Controlling costs for logistics services, materials and equipment

Don’t miss reading Russian Good Distribution Practices Pharmaceutical Regulations Part 1 and Part 2 of this series, and return for part four where we will answer the question: What is calibration, and why is it required for in-transit and storage temperature monitoring under the Russian GDP regulations? In the coming month we will bring you an in-depth review of in-transit requirements, including lane risk assessments, trailer mappings and ongoing temperature monitoring.

For questions about the Russian “Rules for Proper Storage and Transportation of Medicines” or information about Sensitech’s thermal mapping studies, visit our Professional Services site or contact us.