Proper storage and transportation of finished drug products are critical activities in an integrated supplychain. These finished drug products include but are not limited to temperature sensitive small molecules, vaccines, biologics, biotechnological products, radiopharmaceuticals, and combination products.
Environmental controls play a key role in maintaining drug safety, quality, and efficacy. Temperature is one of the most important parameters to control. Drugs must be stored and transported according to predetermined conditions (e.g., temperature) as supported by stability data.
Temperature excursions outside of their respective labeled storage conditions, for brief periods, may be acceptable provided that stability data and scientific/technical justification exist, demonstrating that product safety, quality, and efficacy is not affected.
To maintain the original quality, every party involved in the storage and transportation of a finished product should have an in-depth understanding of the storage and transportation risks and have the appropriate mitigation strategies in place to control these risks.
Product knowledge includes but is not limited to the following:
- intended use;
- storage conditions;
- potential hazards to environment and personnel;
- inherent vulnerability
Process knowledge includes but is not limited to the following:
- knowledge of supply chain partners;
- physical modes of transportation;
- transportation routes;
- national and international regulation.
Understanding these factors helps an organization identify their associated risks. Risk identification is the systematic use of information to identify potential sources of harm (hazards).
Process mapping is a useful tool for organizations to gain further understanding of a particular process and/or operation.
Mitigation strategies are part of the risk control process, specifically risk reduction. Risk reduction can include actions taken to mitigate the severity or probability of harm.
Processes that improve the detectability of hazards and quality risks can also be used as part of a risk control strategy.
Generally, mitigation strategies fall within four categories related to:
1) documentation
2) training
3) resources
4) qualification and validation
Documentation is a category of risk mitigation. e.g. quality manuals; SOPs; records etc. The facility should be designed to maintain the quality and integrity of the stored drug product. All vehicles used in supply chain activities should be suitable for the intended purpose.
Before an information system is brought into use, it should be demonstrated through appropriate validation or verification studies that the system is capable of achieving the desired results.
Reference: USP 1079
