Which of the following is not required of all non-sterile compounded products? (Select ALL that apply.) Answer A NDC numbers B FDA approval C Regulation by the Dietary Supplemental Health and Education Act (DSHEA) D Beyond use dates E Prepared under Current Good Manufacturing Practices (CGMPs)

BYD is required – doesn’t require all More test answers on https://studyhippo.com/non-sterile-compounding-and-sterile-compounding/

Which of the following statements concerning FDA approved manufactured drug products is/are correct? (Select ALL that apply.) Answer A FDA approved drugs must have an approved NDA. B They must be manufactured under Current Good Manufacturing Practices (CGMPs). C They must have a manufacturer’s expiration date on the bottle/package label. D They must each have an NDC number. E They include compounded preparations.

FDA approved drug products must have an approved NDA, be produced under Current Good Manufacturing Practices, and have an NDC number. They must also have a manufacturer’s expiration date on the bottle/package label. More test answers on https://studyhippo.com/non-sterile-compounding-and-sterile-compounding/

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Good Manufacturing Practices Flashcards, test questions and answers

Discover flashcards, test exam answers, and assignments to help you learn more about Good Manufacturing Practices and other subjects. Don’t miss the chance to use them for more effective college education. Use our database of questions and answers on Good Manufacturing Practices and get quick solutions for your test.

What is Good Manufacturing Practices?

Good Manufacturing Practices (GMPs) are a set of guidelines that help ensure the quality, safety, and efficacy of products manufactured for human consumption. They provide manufacturers with a framework for ensuring that their products meet all applicable standards and requirements set by regulatory bodies. They also provide consumers with assurance that the food they are eating is safe, wholesome, and of good quality. GMPs cover everything from premises hygiene to employee training to product testing and traceability.The purpose of GMPs is to protect public health by reducing risks associated with food production or manufacturing processes. This includes preventing contamination or other hazards from occurring during the process or while in storage or transport. GMPs also help reduce the risk of product recalls due to contamination or misbranding issues. In addition, GMPs help manufacturers comply with laws and regulations related to food safety as well as adhere to industry standards for quality assurance and control procedures. Manufacturers must develop policies that define their processes for manufacturing products in accordance with GMP guidelines. These policies should include methods for identifying potential hazards associated with production, ways of preventing contamination from occurring throughout the process, ways of verifying product safety after manufacture, measures for protecting against adulteration during transport/storage/distribution, plans for responding quickly when problems arise (such as recalls), etc. Manufacturers should also track records documenting compliance with these policies on an ongoing basis in order to demonstrate accountability should any problems arise down the line. In summary, Good Manufacturing Practices provide manufacturers with a comprehensive approach towards ensuring their products are safe and effective while protecting public health at large by minimizing risks associated with food production processes or other related topics such as storage/transport/distribution etc.