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- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/02%3A_Introduction_to_Quality_Principles/2.05%3A_Section_5-Quality professionals are limited in their ability to alter the culture of a manufacturing organization. For real change to occur, everyone in the organization must be motivated to change. A successfu...Quality professionals are limited in their ability to alter the culture of a manufacturing organization. For real change to occur, everyone in the organization must be motivated to change. A successful company takes care of its employees' basic needs by cultivating a culture of respect, fairness, and rewards for a job well done. These key ingredients are powerful motivators that inspire employees to work hard and conscientiously for the company.
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/10%3A_FDA_Enforcement/10.02%3A_Section_2-If the label is missing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or nu...If the label is missing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count Additionally, the BIMO serves to determine the accuracy and reliability of clinical trial data submitted to the FDA and to assess compliance with the FDA's regulations governing the conduct of clinical trials.
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/04%3A_The_Food_and_Drug_AdministrationLearning Objectives Explore the origin of regulations in the U.S. Discuss the role and organization of the Food and Drug Administration Identify products the FDA has regulatory authority Explore the v...Learning Objectives Explore the origin of regulations in the U.S. Discuss the role and organization of the Food and Drug Administration Identify products the FDA has regulatory authority Explore the various FDA offices & Centers responsible for product approval Distinguish between CFR, Guidelines, and Points to Ponder Demonstrate the use of the eCFR database to locate regulations
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/08%3A_Medical_Device_and_Combination_ProductsObjectives Understand how the FDA classifies a medical device Describe how FDA regulates approvals: PMN, PMA, IDE, and IRB Understand regulations that govern medical devices Explore and apply CFR 82 D...Objectives Understand how the FDA classifies a medical device Describe how FDA regulates approvals: PMN, PMA, IDE, and IRB Understand regulations that govern medical devices Explore and apply CFR 82 Differentiate between Class I, II, & III medical devices Distinguish between IVD, IUO, RUO, LTD, GPR, & ASR Understand ISO 13485 and why it is important in device regulation even though it is regulated by the FDA through CFR 820 Provide examples of combination products
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_BiosciencesThis 125-page course textbook, entitled Quality Assurance & Regulatory Affairs for the Biosciences, was created by Jack O'Grady, M.S., professor at Austin Community College. This textbook accompanies ...This 125-page course textbook, entitled Quality Assurance & Regulatory Affairs for the Biosciences, was created by Jack O'Grady, M.S., professor at Austin Community College. This textbook accompanies the course BITC 1340: Quality Assurance for the Biosciences.
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/09%3A_Regulation_of_Food_and_Other_Products/9.04%3A_Section_4-The CVM regulates veterinary drugs under the authority of the Animal Drug Amendments to the FD&C Act (in 1968) in which provisions were added to ensure animal drugs, as well as human drugs, were safe ...The CVM regulates veterinary drugs under the authority of the Animal Drug Amendments to the FD&C Act (in 1968) in which provisions were added to ensure animal drugs, as well as human drugs, were safe and effective. These biologics follow the same regulatory and approval pathway as other animal drugs and must be safe and effective for the diagnosis, prevention, and treatment of animal diseases.
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/08%3A_Medical_Device_and_Combination_Products/8.01%3A_Section_1-As defined by 201(h) of the FD&C Act, a medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article intended for use in...As defined by 201(h) of the FD&C Act, a medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals…" (fda.gov)
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/05%3A_Good_Guidance_Practices_(GXPs)Guidance documents and guidelines are used to relate the FDA's current regulatory principles and practices for the manufacturing of products. Previously, you were introduced to some of the good practi...Guidance documents and guidelines are used to relate the FDA's current regulatory principles and practices for the manufacturing of products. Previously, you were introduced to some of the good practices that the FDA regulates, along with their CFRs; Current Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices. In this chapter, we will extend it to Good Documentation Practices as well and discuss some of the more relevant documents to regulatory affairs.
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/04%3A_The_Food_and_Drug_Administration/4.02%3A_Section_2-The FDA is an administrative agency created to regulate food and drug supplies in the United States for the safety and health of its citizens. FDA is an agency within the Department of Health and Huma...The FDA is an administrative agency created to regulate food and drug supplies in the United States for the safety and health of its citizens. FDA is an agency within the Department of Health and Human Services. While the FDA has traditionally focused on the US markets, with the global market growth (of imports and exports of products and raw materials) the FDA now manages over 2 trillion dollars of goods manufactured in over 150 nations worldwide (FDA, FDA Global engagement report, 2016).
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/01%3A_Introduction_to_Biotechnology_and_Quality_Assurance/1.06%3A_Quality_PrinciplesMost quality systems are based on the marriage of two main quality principles; Total Quality Management and Continuous Improvement. Meaning, the customer determines quality specifications, everyone in...Most quality systems are based on the marriage of two main quality principles; Total Quality Management and Continuous Improvement. Meaning, the customer determines quality specifications, everyone in the company is responsible for product quality, and there is a formal process to continually improve the processes to ensure quality products.
- https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/10%3A_FDA_Enforcement/10.03%3A_Section_3-Regulations must be enforceable to be effective, and the FDA has plenty of tools to encourage compliance. The key to the FDA is product public health and safety. Enforcement proceedings usually take p...Regulations must be enforceable to be effective, and the FDA has plenty of tools to encourage compliance. The key to the FDA is product public health and safety. Enforcement proceedings usually take place after an inspection has been deemed OAI. The inspections, through appropriate centers, can be either every two years or as indicated by an issue the FDA has been made aware of. There are two broad categories of enforcement activities; civil and criminal.
