How often should facilities and equipment be inspected under GMP guidelines?

Facilities and equipment should be inspected regularly, as defined by the quality system, in accordance with GMP guidelines. This approach ensures that inspections are conducted based on the specific needs of the operations, the complexity of the equipment, the frequency of usage, and the established criteria within the quality management system. The quality system should dictate the frequency and depth of the inspections, promoting a proactive stance toward maintaining compliance and operational integrity.

Regular inspections help identify and rectify potential issues before they escalate, thus upholding product quality and safety. This practice aligns with the principles of quality assurance, demonstrating a commitment to continuous monitoring and improvement within the manufacturing process. It also supports compliance with regulatory requirements, where regular checks are critical for verifying that facilities and equipment operate within their defined specifications and are suitable for their intended use.