Certified Pharmaceutical GMP Professional Practice

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Prepare for the Certified Pharmaceutical GMP Professional Exam. Use flashcards and multiple-choice questions, each with detailed hints and explanations. Ace your certification!

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What is required for new equipment used in pharmaceutical manufacturing?

Must be used without prior installation
Should be installed and may require FDA pre-approval
Does not require documentation
Should be acquired from a non-verified source

The correct answer is: Should be installed and may require FDA pre-approval

New equipment used in pharmaceutical manufacturing must be installed properly and may require FDA pre-approval to ensure compliance with regulatory standards. The installation process itself is critical, as it involves setting up the equipment in a manner that meets Good Manufacturing Practices (GMP) and ensures that it can operate effectively within the production environment. Moreover, certain types of equipment, especially those that have a significant impact on product quality, may fall under regulatory scrutiny and require pre-approval from the FDA before they can be used in the production process. This is crucial for maintaining quality assurance and ensuring that the equipment meets specific safety and efficacy criteria. The requirement for proper documentation is another essential aspect, as it provides a traceable record of compliance and validation. This documentation verifies that the equipment is suitable for its intended use and aligns with established quality standards. Thus, proper installation and potential pre-approval are pivotal steps in integrating new equipment into pharmaceutical manufacturing.