GxP Topics in Pharmaceutical Industry

Let’s exploring the Topics in GxP Compliance within the PharmaceuticalIndustry.

1. Good Manufacturing Practice (GMP)

GMP ensures that pharmaceutical products are consistently produced and controlled according to quality standards. This includes guidelines for facilities, equipment, personnel, documentation, and processes.

2. Good Laboratory Practice (GLP)

GLP ensures the reliability and integrity of non-clinical laboratory studies conducted for regulatory purposes. It covers aspects such as study design, data recording, analysis, and reporting.

3. Good Clinical Practice (GCP)

GCP ensures the ethical conduct of clinical trials and the protection of human subjects involved in these trials. It covers aspects such as trial design, participant recruitment, informed consent, data collection, monitoring, and reporting.

4. Good Pharmacovigilance Practice (GVP)

GVP focuses on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It involves activities like monitoring drug safety profiles, collecting and analyzing safety data from various sources.

5. Good Documentation Practice (GDP)

GDP focuses on data integrity ensuring ALCOA+ principles. These principles form a critical checklist to ensure that data is trustworthy and reliable.

6. Good Distribution Practice (GDP)

GDP ensures that pharmaceutical products are stored, transported, and distributed in a manner that maintains their quality and integrity throughout the supplychain . It covers aspects such as storage conditions, transportation methods, temperature control systems, and traceability.

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Resource Person: Ershad Moradi