Russian Good Distribution Practices Pharmaceutical Regulations, Part 2
Requirements for Pharmaceutical Storage and How to be Compliant
Now we have established the key elements of the Russian regulations in the Sensitech blog: Russian Good Distribution Practices Pharmaceutical Regulations: How to Prepare Your Supply Chain – Part 1, let’s dive deeper into some sections to explain the various requirements, their relevance, and most importantly how to meet regulation scrutiny by during a regulatory audit.
Below is a summary of the top ten requirements from the Russian “Rules for Proper Storage and Transportation of Medicines” that can help you better prepare your storage conditions and meet requirements for an audit.
- The equipment and storage areas must be “fit for use” and secure. They should be able to maintain the right environmental conditions (temperature, humidity) as required for that pharmaceutical product.
- 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.
- Personnel must be trained and assessed which must be documented based on Good Distribution Practices and on the Standard Operating Procedures affecting their job.
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
It is recommended even before implementing a permanent facility monitoring system, to thermal map your facility. Regulatory guidelines require thermal mapping analysis to define worst case positions to prove proper placement of sensors. Sensitech® Professional Services experts help companies with Thermal Mapping Studies to identify worst case hot/cold positions in your facilities and for other smaller equipment. Additionally, Sensitech can provide Full Storage Validation Services IQ, OQ, PQ documentation for your facilities and equipment and an ongoing stationary monitoring system.
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.
Don't miss Part Three of the Sensitech blog series about Russian Good Distribution Practices Pharmaceutical Regulations: Requirements for Transportation and How to be Compliant.