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Date: 22 May 2012
Time: 19:45
Validation of temperature controlled storage areas
Why validate?
If healthcare products are not stored under specified conditions, stability may be compromised and shelf life reduced.
Stability is compromised by temperature extremes or fluctuation. High temperatures increase the rate of degradation and decrease its shelf life. Inappropriately low temperatures may cause harm. For example, refrigeration may cause extreme viscosity in some liquid drugs and cause crystallization and precipitation in others. Freezing can denature proteins and can cause less soluble polymorphic states of some drugs to form.
Statutory and ethical requirements
There are several statutory and ethical requirements (listed below) which govern the storage of medicinal products, blood banks and departments responsible for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
- RPSGB Code of Ethics1
- Controls Assurance 3
- The Blood Safety and Quality Regulations 20052
- Directive 2004/23/EC2
- Good Manufacturing Practice1
- Good Distribution Practice1
- Risk and Consequence3
- Quality Assurance of Asceptic Preparation Services1
1 Regulations governing pharmaceutical products
2 Regulations governing blood and tissue banks
3 Guidelines applicable to all areas
Frequency of monitoring
The Orange Guide sates that of large commercial refrigerators and walk-in cold rooms that:
"Internal air temperature distribution should be mapped on installation in the empty and full state and annually thereafter under conditions of normal use."
Services we offer
Services provided by Quality Control West Midlands include:
Audit
A standard audit would include:
- Inspection of storage areas to determine current practices
- Identification of applicable regulatory compliance issues
- Briefing staff on current regulations and best practice
- Detailed report covering all issues identified during the audit process
Validation
- Operational qualification of new appliances/environments
- Performance verification of existing appliances/environments
