Course Description
Temperature mapping is one of
the major requirements of the Pharmaceutical good distribution practices,
impacting temperature-controlled facilities. Companies are obliged to provide
evidences about how the airflow is moving with those areas and if they are
suitable to store medicines.
This short training
highlights, the most important aspects of temperature mapping requirements, and
what information should be part of the documentation.
What you will learn
- What are temperature controlled areas
- Why we need to map areas
- What are the variables that condition the air flow
- What is the scope of a temperature mapping
- What is the crash and stress test
- What is the mapping process
- Equipment Requirements for the mapping
- Sensor placement and location
- Mapping protocol
- Hot & cold spots
- Final report
To whom it is addressed
All Job functions that are
responsible for qualification of temperature-controlled areas (NOT vehicles):
- Logistic Managers
- Supply Chain Managers
- GDP responsible persons
- QA Managers
- Responsabile persons IATA CEIV Pharma