Manufacturing

Sterile-filled Vials

The manufacturing or "production" area is where the drug products are actually made with the active pharmaceutical ingredients and other materials such as high-purity water or sugars and other binding/lubricating agents. Depending on the final product, the manufacturing process can be very simple or extremely complicated.

Example of a GMP expectation that applies to Manufacturing

Equipment is designed and located to serve its intended purpose and to facilitate its cleaning and maintenance.

Example of GMP requirements specific to this GMP expectation

  U.S.

• Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. [211.63]

  Canada

• Equipment parts that come in contact with raw materials, in-process drugs or drugs are accessible to cleaning or are removable. [C.02.005 #1.1]

• Equipment is located at a sufficient distance from other equipment and walls to permit cleaning of the equipment and adjacent area. [C.02.005 #1.4]

• Equipment is kept clean, dry, and protected from contamination when stored. [C.02.005 #1.6]

  European Union

• Manufacturing equipment should be designed, located and maintained to suit its intended purpose. [EU #3.34]

• Manufacturing equipment should be designed so that it can be easily and thoroughly cleaned. [EU #3.36]