Cleaning Validation ( MPHARM)

Which of the following is NOT true for Cleaning Verification

• Method may be changed

• Can be done once in 6 months

• Analytical method should be available

• needs to be done after each batch

Cleaning validation Protocol must be written

• Before conducting Cleaning Validation

• After conducting Cleaning Validation

• Can be written online ( contemporaneous)

• None of the above

Generally the TOC limit of Cleaning Validation is set at

Which sampling method is preferred by FDA

• Rinse method

• Placebo method

• Direct swab method

• All are equally allowed

For cleaning an equipment which of the following is important

• 1. 1 Cleaning Operator Training

• 2 Analyst training

• 3.Identifying difficult to rinse parts in Equipment

• 2 and 3

• All of the above