Receiving and Shipping

General Warehousing Area

Most companies have one area devoted to receiving and storing raw materials and another one dedicated to storing and shipping products that have been approved by the QC - Batch Release department. Precautions are taken to ensure the identity and "status" (e.g., approved or not approved) of all items. Also, storage conditions are important so temperature-sensitive chemicals and drugs are not adversely affected.

Example of a GMP expectation that applies to Receiving and Shipping

Raw materials, components, packaging materials, work-in-process, and finished products are stored under conditions that contribute to their safety, identity, strength, purity, and quality.

Example of GMP requirements specific to this GMP expectation

  U.S.

• Written procedures describing the warehousing of drug products shall be established and followed. They shall include: Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected. [211.142(b)]

• There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed. [211.80(a)]

  Canada

• Raw materials, packaging materials, intermediates, bulk drugs and finished products are (a) stored in locations separate and removed from immediate manufacturing areas, and (b) transported under conditions designated by the quality control department to preserve their quality and safety. [C.02.011 #48]

  European Union

• Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored. [EU # 3.19]