How can the research site determine and ensure that the investigational drug being tested is in compliance with CGMP and meets Quality Guidelines?
How can the research site determine and ensure that the investigational drug being tested is in compliance with CGMP and meets Quality Guidelines?
Contract Manufacturing – Controlling for Quality
Although the manufacturing of drugs is not done at the clinical site, it can be argued that it is still very much related to the conduct and quality of clinical trials. The investigator, and under the supervision of the investigator, the study staff are responsible for the safety and welfare of study subjects. Understanding the requirements and quality measures for manufacturing drugs may be considered part of that safety. Understanding the life cycle of the drugs that are being investigated including the manufacturing practices could be an implicit part of ensuring quality and safety for research subjects.
In 2016 the FDA issued a guidance document: Contract Manufacturing Arrangements for Drugs: Quality Agreements (see link above). Review this guidance document and respond to the following question:
The owner (sponsor/manufacturer) of the drug is ultimately responsible for its quality. Study sites are responsible for distributing the product per protocol, being accountable for drug disbursement, and tracking safety via adverse events. 1.) How can the research site determine and ensure that the investigational drug being tested is in compliance with CGMP and meets Quality Guidelines? 2.) Does the site need to be concerned about the quality of the drug? Explain.
Requirements: parapgraph per answers; 7 sentences minimum per paragraph
Subject: Health & Medical
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