Certified Pharmaceutical GMP Professional Practice

What is a key requirement for a building used in drug manufacturing?

1. It should be centrally located within the city

2. It must have inadequate physical barriers

3. There must be adequate ventilation and proper physical barriers

4. Size and construction do not matter

The correct answer is: There must be adequate ventilation and proper physical barriers

A key requirement for a building used in drug manufacturing is that there must be adequate ventilation and proper physical barriers. Adequate ventilation is essential to ensure a safe working environment, control temperature and humidity, and prevent the accumulation of airborne contaminants that could affect product quality or worker health. An effective ventilation system helps to maintain clean air by filtering out particulates and controlling harmful airborne substances. Proper physical barriers play a critical role in preventing contamination. They separate different areas of the manufacturing facility, which helps manage cross-contamination between raw materials, intermediates, and finished products. These barriers also protect the production environment from external contaminants and assist in maintaining controlled conditions necessary for compliance with Good Manufacturing Practices (GMP). Considering the other options, it’s clear that they do not meet the necessary standards for pharmaceutical manufacturing facilities. For instance, centralized city locations do not inherently enhance safety or compliance, inadequate physical barriers would increase contamination risks, and size and construction are indeed important factors in ensuring the facility meets regulatory standards and operational needs. Thus, the focus on adequate ventilation and proper physical barriers aligns with GMP requirements for ensuring product quality and safety.