If you operate a 503A compounding pharmacy, preparing for an FDA inspection is not the same as preparing a conventional pharmaceutical manufacturing facility for a CGMP inspection. Drugs compounded in accordance with the conditions of Section 503A may qualify for exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act, including federal current

Spreadsheets are among the most widely used tools in pharmaceutical, biotech, and medical device operations. Nearly every organization uses them in some form, and for many applications they are flexible, familiar, and highly effective. In smaller operations especially, spreadsheets are often used to track calibration schedules, preventive maintenance activities, instrument inventories, and qualification status. For

For any company operating in a regulated industry  whether pharmaceutical, biotech, medical device, or nutraceutical  an FDA inspection is not a matter of “if.” It is a matter of “when.” The Food and Drug Administration conducts thousands of domestic and international inspections every year, and the stakes are high. A single unresolved observation can result

A GxP calibration program should define its scope, instrument criticality, responsibilities, approved procedures, suitable calibration standards, metrological traceability, calibration intervals, required records, and the handling of overdue or out-of-tolerance work. Intervals, tolerances, and controls should be justified for the instrument and the process it supports. Software can support scheduling, records, traceability, and retrieval, but it

Choosing the right validated CMMS is one of the most important compliance decisions a growing regulated company can make. The system you select will directly impact your ability to pass FDA audits, maintain inspection-ready records, and demonstrate equipment control at every stage of your operations. Not every CMMS is built for regulated environments. Many general-purpose

Preparing for an FDA Pre-Approval Inspection (PAI) can be stressful but strong maintenance practices help your team demonstrate control, compliance, and readiness. FDA inspectors expect clear evidence that your equipment, utilities, and facility are properly maintained and operating in a validated state. Maintenance gaps, overdue preventive maintenance, or incomplete documentation can quickly raise concerns and