GMP Audit Check List- Process Validation

GMP Audit Check List- Process Validation

List of the points to check before the GMP audit regarding the Process Validation

1.    Is validation, properly done to all critical production procedures? (Indicate all critical production procedures for which validation is done?

a.    conducted in accordance with previously defined procedures?

b.    result maintained?

c.   extension and degree dependable on the value and complexity of the product and process?

2.   Do the validation program and documentation provide

a.   evidence of suitability of equipment and systems?

b.   the performance and reliability of equipment and systems?

c.   the competency of personnel?

3.   Are the adopted Master Processing Procedures based on the process validation?

4.   Are further validation steps done if significant change occurred in Process, Equipment & Materials?