Audit - 20
Audit Manual 20 - Auditing an Aseptic Sterile Area
Perform an audit of an aseptic/sterile processing area. Access and understand aseptic/sterile manufacturing requirements. Understand worldwide regulatory agency requirements for aseptic/sterile processing. Use a range of information tools, from the content
Audit 20 - Auditing an Aseptic Sterile Area
A number of dosage forms are required to be sterile e.g.to be without viable microorganisms. Examples of dosage forms required to be sterile are eye-drops, injectables and large volume parenterals. They are required to be sterile to ensure the safety of patients, which includes aspects as route of administration and risks for infections. Sterility cannot however be guaranteed through testing; rather, it is assured through the application of a validated production process. Medical devices are often required to be sterile and they are put through a terminal sterilization process. It is not the intention of this training module to explicitly cover the manufacture and sterilization of medical devices.
http://www.gmpsop.com/sample/Audit-020-Auditing-an-Aseptic-Sterile-Area-sample.pdf
A number of dosage forms are required to be sterile e.g.to be without viable microorganisms. Examples of dosage forms required to be sterile are eye-drops, injectables and large volume parenterals. They are required to be sterile to ensure the safety of patients, which includes aspects as route of administration and risks for infections. Sterility cannot however be guaranteed through testing; rather, it is assured through the application of a validated production process. Medical devices are often required to be sterile and they are put through a terminal sterilization process. It is not the intention of this training module to explicitly cover the manufacture and sterilization of medical devices.
http://www.gmpsop.com/sample/Audit-020-Auditing-an-Aseptic-Sterile-Area-sample.pdf