A pharmaceutical manufacturer installs a new mixing vessel i…

A pharmaceutical manufacturer installs a new mixing vessel intended for use in tablet production. Production staff want to begin manufacturing immediately, but the Quality Manager states that the equipment cannot be used until qualification activities are completed. Which sequence of qualification steps must be performed before the equipment can be released for routine GMP manufacturing?

A pharmaceutical company contracts a third-party manufacture…

A pharmaceutical company contracts a third-party manufacturer to produce a sterile injectable product. After manufacturing, the finished product is delivered to the company for final release and distribution. Which statement best describes the responsibility for product quality and regulatory compliance?

A GMP inspector requests the SOP for a line-clearance cleani…

A GMP inspector requests the SOP for a line-clearance cleaning procedure currently being performed. The staff are unable to provide any controlled version of the document. What does the inspector expect to see in a “controlled document” as opposed to a document not controlled?