GMP Audit checklist for Process Validation

Process validation

• Has the master plan been prepared for validation describing the entire production process?
• Is the master formula based on the approved process validation?
• Is validation of every phase of production process done in accordance with the approved validation protocol?
• Are the records and conclusions of validation studies prepared and maintained properly?
• Does the performed process validation covers all risk based aspects and approaches?
• Is revalidation done on requirement and in accordance with the procedure?

Process, validation, master formula, gmp audit checklist

• mcrhrdi.gov.in
• cdsco.nic.in