Storage areas - 2
Appropriate temperature and relative humidity conditions within defined limits
- Provided, controlled, monitored and recorded
Good storage conditions: clean, dry and appropriate lights
I will now go through the main areas of the factory and highlight a few key points in each area.
The importance of the warehouse is sometimes under estimated. Incoming goods areas are often the forgotten places at the back of the factory. However, they should be seen as the first point of entry of materials into the factory, and the last point at which the factory still has control of its products before they leave to go to a customer. Warehouses should have sufficient capacity to allow orderly storage of the various categories of materials and products, for example: starting and packaging materials, intermediates, bulk and finished goods, products in quarantine, and released, rejected, returned or recalled goods.
The design must ensure protection against the heat or moisture. It must also provide protection for special deliveries such as tankers. These give rise to special problems. For example, what measures are in place to ensure a clean connection between the tanker and the holding tank? What precautions are taken to ensure that the tanker is using clean transfer pipes before transferring materials into the tank? Is there a static electricity discharge point for safety purposes where necessary?
All the material requirements with regard to temperature and humidity control must be adhered to. This means suitable records have to be maintained and procedures available to describe what to do in the case of failure of cooling equipment or the electricity supply. How long may materials remain exposed to unsatisfactory temperature or humidity conditions? This question must be able to be answered by the responsible staff in the factory. They should have SOPs describing the various storage conditions required and specifying which materials should be stored there. Examples of materials that need special controls are vaccines and gelatin capsules.
Incoming goods containers may be stored outside. They may need to be cleaned before they can be opened for sampling, and before they go into the warehouse. Facilities for this will need to be provided.
These areas must be designed to provide sufficient space to accommodate the deliveries or shipments passing through them. The areas should be operated in accordance with appropriate SOPs.