Question 1
Testing alone cannot be used as the only measure of ensuring the quality of a product. The quality is based on the desired purity, strength, identity, and other characteristics. Hence, the FDA can only protect the average consumer by assuring the final good meets the criteria for effectiveness and safety. Otherwise, simply inspecting the international manufacturing facilities does not help the average buyer. The organization needs to establish a quality system that will oversee the measurements, evaluate and document the changes, and provide an action program that will address the issues that affect the product quality and performance (Buckley and Blanks, 2009).
Question 2
The materials used in the first phase of GMP are less safe that those utilized in the other phases. The obvious reason is the updated skills and knowledge that has considered new factors and concepts for the clinical trials. The first stage introduces investigational medicine to human subjects with the GMP striving to maintain the safety of the people (U.S. Department of Health and Human Services et.al, 2008). For the drug to proceed to the other phases, it must have been proven safe to use by the guidelines of the first stage. Certain crucial provisions are not implemented in the first phases such as clearance rules and emission topography.
Question 1
The administrative body protects the welfare and rights of subjects in a study recruited to take part in the research operations. They have the power to modify, disapprove, and approve study activities that do not satisfy institutional policies and federal regulations. It also functions as an independent commission but in coordination with societies. The independence arises from their authority to make decisions concerning research protocols that may harm subjects (Institutional Review Board, 1993).
Question 2
Before the reviews involving the human subjects can be conducted, IRB must provide the agency or department with a documented Assurance that it will conform to the stipulations of the Policy. After that, the institution certifies that agency to go ahead with their research (Institutional Review Board, 1993). The assurance, in this case, circumnavigates various regulations such as the statement of principles that include the ethical standards, declaration, and existing codes. For instance, in the U.S. most departments cite the Belmont Report.
Question 3
IRB maintains and prepares adequate documentation of its operations such as written IRB membership and procedures needed by the Assurance regulations. Such documentation includes minutes of IRB conferences, review activities, statements of findings, correspondence of the investigators, and copies of proposals evaluated. The records are kept at sufficient levels and are retained within three years after the completion of a research project (Institutional Review Board, 1993).
The bioresearch processes are subjected to different regulations and supervisions to ensure that firms do not violate the Federal Law for operations relating to the approval and development of the studies. If they interfere with the policy, they are specific measures put in place to punish them for the felonies they commit. Some guidance and regulations of bioresearch monitoring include compliance guides, programs, and lists as well as FDA regulations and application integrity rules. Clinical investigators are employed to evaluate the proceedings of the projects and possess the power to disqualify the initiatives that do not conform to the compliances. The policies ensure that there is a memorandum of understanding between the companies and FDA. They also prevent untrue and fraudulent material facts and other illegal actions (U.S. Department of Health and Human Services, 2016). The FDA is expected to assess the quality of the results of the reviews through program inspections and audits. The Federal regulations warrant that the research should safeguard human subjects. The institutions and devices utilized in the studies are also investigated. Through this, the quality and provisions of the bioresearch instruments are maintained.
References
Buckley B. and Blanks R. (2009). Overview of the GxPs for the Regulatory Professional. Cambridge: Idenix Pharmaceuticals, Inc.
Institutional Review Board. (1993). Chapter 1: Institutional Administration. Retrieved March 30, 2016 from http://www.hhs.gov/ohrp/archive/irb/irb_chapter1.htm.
U.S. Department of Health and Human Services et.al (2008). Guidance for Industry: CGMP for Phase 1 Investigational Drugs. CGMP: Rockville.
U.S. Department of Health and Human Services (2016). Bioresearch Monitoring. Retrieved March 30, 2016 from
http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/default.htm.
