The stability of a pharmaceutical or biopharmaceutical product must be maintained throughout its shelf life. Furthermore, for products that require cold chain distribution, it is essential to document that they were maintained within a validated temperature range during their storage and shipping. Critical and significant regulatory observations often pertain to inadequate temperature control and monitoring during storage and transportation. And costs are high. Multiple parties are involved in the pharmaceutical supply chain, and all have to be aligned and integrated to achieve and maintain compliance with cold chain validation. Cold chain validation studies are becoming more dynamic, to incorporate real-world factors and conditions. Cold chain validation is a mandatory part of the entire quality control process, confirming that every link in the chain is tested to comply with regulatory requirements.

Regulatory requirements mandate that pharmaceutical produce in transit or storage must not be subjected to temperatures that can induce unwanted changes to their efficacy, quality, or purity.

Some of these regulatory requirements include:

  • WHO’s “Good distribution practices for pharmaceutical products” and “Guide to good storage practices for pharmaceuticals.”
  • FDA 21 CFR part 211.142
  • U.S. Pharmacopeia (USP) <1079> “Good Storage and Shipping Practices.”
  • Canada’s “Guidelines for Temperature Control of Drug Products during Storage and Transportation”
  • Ireland’s “Guide to control and monitoring of storage and transportation temperature conditions for medicinal products and active substances.”
  • EU’s “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” (94/C 63/03)

Unfortunately, there are many challenges in using the traditional paper-based approach for  cold chain validation:

  • A silo approach where there is no integration between design, qualification, and continued monitoring of temperature
  • Risk assessment and mitigation activities for attributes, parameters, and process designs are maintained in basic spreadsheets and paper documents without an easily accessible audit trail
  • The current manual approach is prone to lack of visibility, data integrity issues, and noncompliance
  • Manual and time-consuming planning of control strategy and documentation
  • Temperature monitoring is done during drug transport through local data loggers where the probability for missing devices and/or tampered devices is high.
  • The collected data from data loggers is maintained in a database or files, leading to Islands of information and can be lost in a sea of paper documents, databases, and file folders

IoT in ValGenesis VLMS

ValGenesis VLMS supports IoT devices for continuous monitoring of temperature, light, pressure, and humidity. After a drug is manufactured, the supply chain reaction starts to unwind. From shipment to transit and delivery into pharmacies or hospitals, there is a risk of encountering an unexpected difficulty. Sudden temperature fluctuations could lead to adulterated drug products.

If the drug product is temperature-dependent, smart sensors for ambiance detection can be added as well; the same goes for pressure, light, and humidity. Logging current temperature, pressure, light, and humidity, the sensors instantly alert required personnel in case of discrepancy with validated limits. Such timely measures help to avoid drug discard due to unfulfilled transportation conditions. Upon delivery, a 360-degree report (comprising all acquired data across the supply chain) will help to elicit the scope of elements needing improvement, to make the process smoother with reduced time-to-market.

Automated Cold Validation lifecycle through ValGenesis VLMS

The ValGenesis VLMS automates the validation lifecycle by integrating all stages of cold chain validation, from process design to qualification and continued monitoring against validated limits.

Our Validation Plan drives all stages of cold chain validation and enforces the required studies and deliverables at every stage, with required dependencies between the studies and deliverables

Using risk assessment models, the ValGenesis VLMS helps to conduct a risk assessment and mitigation plan for packaging design and parameters

Validation deliverables are electronically created, reviewed and approved, eliminating paper from the validation process

ValGenesis VLMS dynamically collects data on temperature, humidity, and pressure as per predefined schedules and provides real-time analytics to eliminate human errors and ensure a high degree of data integrity

100% electronic approach to cold chain validation in compliance to 21 CFR Part 11, Annex 11,and data integrity requirements

Compliance with FDA 21 CFR part 211.142 and EU’s “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” (94/C 63/03) for cold chain validation requirements



Blockchain and Data Integrity