GMP Audit checklist for Equipments in Pharmaceuticals

Based on Good Manufacturing Practices for active pharmaceutical ingredients GMP checklist for equipment is given.

• Does the equipment have a system for validation, regular revalidation and revalidation after repairs?
• Does the equipment have a system to calibrate all the instruments?
• Does the equipment has a system to investigate, record and report all deviations or malfunctioning of equipment? 
• Does the equipment’s installation Qualification protocol contain information from introduction, responsibilities, installation description, Qualification acceptance criteria, data recording and reports, performed tests or assays?
• Does the report contain summary & description of performed test and assays, data tables, installation diagrams, results, revision & approval signatures, conclusions?
• Does the equipment operation qualification contain introduction, description of equipment and its operations steps, recording & reporting of data, responsibilities and qualification acceptance criteria, data tables, description of tests and assays, results, revision and approval signatures and conclusion?
• Does the equipment performance qualification has introduction, responsibilities, qualification acceptance criteria, performed assays, recording and reporting of data.
• Does the report has Summary, performed assays description, data tables with results, conclusion, revision and approval signatures?
• Is the schedule for preventive maintenance for equipment is followed and are records available in accordance to it?

Equipment, protocol, qualification, gmp audit checklist

• mcrhrdi.gov.in
• cdsco.nic.in