Storage conditions for medicinal products and active substances in GMP-EU factories.
Food and pharmaceutical production needs to meet GMP guidelines for good manufacturing practices and storage conditions in GMP EU factories according to regulations.
Production of drugs and pharmaceuticals is a process including raw material selection, preservation, production, quality control in the laboratory or storage and preservation in the factory… all steps need to be strictly controlled, preventing defects affecting product quality. Storage conditions in GMP EU factories are a strict standard, which production facilities need to meet.
Warehouse storage conditions in the factory – GMP EU
Not only the process of raw material selection, production, factory machinery is strictly controlled; The delivery and storage is also controlled by conditions and standards, because this is an important step affecting the quality of drug products.
The preservation of raw materials, packaging and finished products in the factory is part of the production process. Requirements for storage warehouses should meet GMP EU standards, which are to eliminate the risk of cross-contamination or contamination by biological and chemical agents from the environment… affecting product quality.
Details about storage conditions in GMP EU standard warehouses.
The EMA organization publicized the storage conditions of GMP EU standard warehouse, which is in order to facilitate uniformity in drug quality management, clearly stated on product labels. Storage conditions must be consistent with the information on the drug label, product information, according to directive 2001/83/EC. Condition details are studied in real time at 25°C/60%RH supported in accelerated conditions where applicable.
Core storage statement.
| Testing conditions where products is stable | Required labelling statement | Additional labelling statement, where relevant |
| 25°C/ 60% RH (long term)40°C/ 75% RH (accelerated)or30°C/ 65% RH (long term)40°C/ 75% RH (accelerated) | None | Do not refrigerate or freeze |
| 25°C/ 60% RH (long term)30°C/ 60 or 65%RH (intermediate) or 30°C/ 65% RH (long term) | Do not store above 30oC or store below 30oC. | Do not refrigerate or freeze |
| 25°C/ 60% RH (long term) | Do not store above 25oC or store below 25oC. | Do not refrigerate or freeze |
| 5°C ± 3°C (long term) | Store in a refrigerator or store and transport refrigerated | Do not freeze |
| Below zero | Store in a freezer or store and transport frozen. |
A factory meeting GMP EU standards needs to build up an area of standard storage areas for raw materials, packaging, semi-finished products and finished products with the following requirements:
- Packaging conditions to preserve the drug in the package: vacuum sealed container, stored in the original packaging, stored in a carton to avoid exposure to light.
- Conditions on equipment for storage of drugs and pharmaceutical products: machinery for cold storage or freezing of medicinal products. Equipment meets standards of fire and explosion prevention, stable operation ability. Also, products that need to be stored/transported in a refrigerator/freezer with temperature limits should be clearly stated on the label.
- Warehouses need to meet environmental requirements: temperature, humidity, acceleration, light. Enterprises are required to install air quality management systems, temperature, lighting systems, etc. to preserve medicines.
In order to build a warehouse to store drugs that meet EU GMP standards, businesses are required to comply with the principles of drug preservation. Conditions for building storage warehouses are based on studies of drug stability in environmental conditions (temperature, humidity, light exposure sensitivity…), proven products of the finished product. , with complete data.
The GMP standards was created to manage the quality of the production system in the factory. Each stage in the production of drugs and food needs to be strictly controlled, with standard conditions. The storage area is an important part, affecting the quality of drugs and pharmaceuticals before and after production that enterprises need to comply with.
Hopefully the above sharing will help businesses better understand the storage conditions in GMP EU factories, in order to build a standard storage system. With a team of experienced experts and engineers of GMP EU Design & Consulting Joint Stock Company, will support businesses to perfect the system to meet GMP EU factory standards.