In pharmaceutical, food, medical equipment and cosmetic industries, the quality of a product and process is directly affected by the awareness and implementation of GMP principles as a general guide. In general, GMP training is divided into 6 general branches, one of which is GSP or Good Storage Practice, which deals with the standards and instructions used in the warehouse.
After the production of a sensitive product or product such as pharmaceutical products, they must be stored in warehouses and warehouse areas until the release permit is issued. The quality of many of these pharmaceutical products may decrease during their storage period, therefore it is necessary for the storage conditions of each product or pharmaceutical product to be in accordance with the conditions that stabilize and prolong its shelf life. Therefore, classifying and creating suitable conditions for storing each material or product is an undeniable necessity.
Therefore, Afa Chemical Pharmaceutical Company has emphasized and paid full attention to observing the principles and regulations of GSP in all its warehouses. Afa Chemical Pharmaceutical Company has 6 separate warehouses, which are: Raw material warehouse, final product warehouse, packaging warehouse, technical warehouse and spare parts warehouse, laboratory reagent warehouse, consumables warehouse. The following are the most important general conditions governing the company’s warehouses:
Pharmaceutical materials and products are stored in suitable conditions to ensure their quality during storage and to prevent contamination, mixing and cross-contamination.
The circulation of materials is based on their expiration date. The principle of first-in/first-out (FEFO) is followed, not FIFO
Raw materials that have just entered the company and are awaiting sampling and testing are stored in a quarantine warehouse that is separated from the main warehouse and a yellow label is attached to the barrels and cartons during the quarantine period.
Regarding the windows in the warehouses, precautions have been taken to prevent direct sunlight from shining on the warehouse materials.
The storage conditions for pharmaceutical materials and products are fully consistent with the contents of the labels on them, which are obtained based on tests and stability studies.
All results related to the control of temperature and humidity conditions in the warehouses are recorded and written down on a daily basis and are kept for at least one year after the expiration date of the product.
All temperature and humidity measuring devices are checked and controlled at specified intervals to monitor warehouse conditions, and the results of these controls and calibrations are written down and kept.
The maximum relative humidity never exceeds 40%.
All pharmaceutical materials and products are stored in containers and packages that do not have adverse effects on their quality and protect against the effects of external factors.
All packages have a label with the name of the material, batch number, expiration date or retest date, special storage conditions, company name and country of manufacture.
All surfaces, cages and cabinets are coated (or painted) with a smooth, water-impermeable and cleanable layer.
Rejected pharmaceutical materials and products are identified under controlled conditions in quarantine and are prevented from being used until a final decision is made on their fate.
Broken and damaged products and items are separated from other storage areas and stored separately.
If any, all returned goods are quarantined and will only be returned to saleable inventory if re-evaluated by the company’s pharmaceutical technical officer.
Periodic inventory checks are performed to compare the actual inventory of goods and materials with the inventory recorded in the system used in the company’s partners software.
If any, all discrepancies between the actual inventory and the recorded inventory are tracked to determine that there has been no mis-mixing, incorrect shipment, etc. in the output of pharmaceutical materials and products.
Sufficient space is provided for each type of pharmaceutical product to prevent their mixing, and if necessary, there is the possibility of storing new products.
