(SOLVED) Outline the differences and similarities between Good Clinical Practice, Good Laboratory Practising, and Good Manufacturing Practice.
a) Outline the differences and similarities between Good Clinical Practice, Good Laboratory Practising, and Good Manufacturing Practice. Your response should be based on medication analysis and formulation manufacturing.
b) Explain why a limit of quantitation (LOQ) is not required to verify an assay or an identification test on a drug product according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline Q2(R1)?
Expert preview answer
a “GMP” is Good Manufacturing Practices, and “GLP” is Good Laboratory Practices. Both the GMP and the GLP are regulations that are governed by the Food and Drug Administration (FDA). These regulations are imposed for ensuring the safety and integrity of drugs.
The major differences between the three types of audits are related to the progressive stages needed to bring pharmaceutical, biologic, and medical device product to market. The main concern in the case of GCP is the health, safety, and rights of the study participant; as well as documentation that the product creates more benefits than harms.
GLP does not involve human subjects, but nonclinical laboratory testing environment and materials. cGMP is focused on the manufacturing after successful clinical and nonclinical testing.
To navigate the regulatory requirements of each type of mandate, a comprehensive understanding FDA priorities is needed. In the remainder of this article, we take a deeper dive into GCP, GLP, and cGMP. Subsequent recommendations regarding leveraging effective audit processes are made.
FDA inspections in GCP, GLP, and cGMP are critical for the successful achievement of maximum safety and effectiveness of pharmaceuticals, medical devices, and other medical products. Be that as it may, for industry leaders, it is a daunting and seemingly unending process.
The FDA Group has a proven track record in facilitating success for numerous life-science organizations. Such a partnership can assure high-quality product research and manufacturing, and most important, public safety.
b LoQ is the lowest concentration at which the analyte can not only be reliably detected but at which some predefined goals for bias and imprecision are met.
LLOQ is the lowest calibration standard on the calibration curve where the detection response for the analyte should be at least five times over the blank. The detection response should be discrete, identifiable, and reproducible. The precision of the determined concentration should be within 20% of the CV while its accuracy should be within 20% of the nominal concentration. The upper limit of quantification (ULOQ) is the highest calibration standard on the calibration curve, where the analyte response is reproducible, and the precision and accuracy are within 15% of the CV and 15% of the nominal concentration, respectively.
The calibration curve should not be extrapolated below the LLOQ or above the ULOQ to determine the analyte concentration in unknown samples. There fore LOQ is not required for verifying an assay or a laboratory testing.