Which framework requires documentation of equipment calibration and validation in manufacturing?

• A. GLP
• B. GDP
• C. GCP
• D. GMP (as part of cGMP)

Answer: (D)

Manufacturing quality hinges on having equipment that is properly qualified, calibrated, and maintained with clear records. This requirement falls under GMP as part of cGMP. GMP dictates that equipment used in production and testing be installed, qualified (IQ), operationally qualified (OQ), and performance qualified (PQ), with documented calibration and validation records kept to prove processes are consistent and within specifications. This traceability helps ensure products meet quality standards and that any deviations can be traced and addressed. The other frameworks focus on different areas: GLP on the integrity of nonclinical laboratory studies, GCP on clinical trials, and GDP on distribution and storage, none of which centrally mandate manufacturing equipment calibration documentation in the same way.