Product Control as it Applies to Quality Assurance
Product Control as it Applies to Quality Assurance essay assignment
Product Control as it Applies to Quality Assurance essay assignment
The quality manufacturing of the investigational medical product impacts the safety and the welfare of the study subjects. Though not a direct part in the conduct of the clinical trial, the quality of the manufactured product impacts the clinical trial. While it is the sponsor’s responsibility to ensure compliance with quality standards, regulations, processes and best practices, it is important for study site staff to understand the process that brings the new product to the study site for investigation of safety and effectiveness. There are multiple areas in the manufacturing process that require quality systems and control. Choose one of the four (4) processes listed below:
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- Product Control (product materials, testing, batch control, storage, access, packaging, handling, labeling, shipping, staff training and qualifications, SOPs, documentation, records, inspections, etc.)
- Equipment (type, maintenance, cleaning, equipment problems and break downs, access, inspections, staff training, documentation, records, SOPs, etc.)
- Facilities (type, space, square footage, special controls for any needed areas, cleaning, inspections, access, SOPs, etc.)
- Manufacturing (manufacturing line, product input through product output, testing, staff training, documentation, records, environment and space, access, SOPs, etc.)
In a 4 page APA 7th Edition formatted paper describe the factors, steps, and controls in the process you chose to ensure compliance with quality standards and requirements. Discuss incorporating quality into the process – quality steps, tasks, activities, staff qualifications and training, controlling for quality, standard SOPs, and other quality factors. Refer to and support your content using FDA guidelines, cGMPs, other regulations and quality standards.