Question

which of the following courses must an associate take if they are assigned to a gxp project

Answer 1

Answer:

Good documentation Practices

Explanation:

Good documentation Practices to be followed for any GxP project as per regulations guidelines

Answer 2

Answer:

Gxp project

Explanation:-The origin of the GxP was to target low quality drug products that affect public health. Several public health incidents, including the 1941 Sulfathiazole Tablets Disaster and the 1960 thalidomide tragedy, prompted the establishment of the modern GxP guidance. GxP is the minimal quality requirements used by the regulatory agencies to regulate pharmaceutical companies. However, GxP should not only be considered as the “minimal” requirements because it provides a fundamental framework for continuous quality improvement. By applying the quality tools described in the GxP guidelines, a company can greatly improve its product quality as it expands its knowledge base. Regulatory agencies also constantly renew their thinking on different GxP topics as the technologies applied in drug product manufacturing progress. First and foremost, GxP is the law. Unlike other quality systems which a company can choose to follow or not, GxP is mandatory for producing and distributing pharmaceutical products. One may face regulatory actions for not following GxP and that includes fines, forfeiture, recalls, and other legal actions. Not following GxP also results in bad quality systems and bad product quality. Many issues, such as product Out Of Specifications (OOS), may arise due to bad quality systems.  Scale-up and process validation stage is critical both to the compliance and business aspects. Several guidelines published by the regulatory agencies (for example, “Guidance for Industry: Process Validation: General Principles and Practices” by the USFDA) should be considered during this stage.  If the product license owner and the CDMO use quality tools from the technology transfer stage, they should have adequate knowledge to quickly moving from pivotal (small) batch scale to commercial (large) batch scale.

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