Cleaning validation

What is the main purpose of cleaning validation (CV) on products in GMP aspects?

• Safety

• Quality

• Efficacy

• None of them

Which are the things should not be contained in product to prove the cleanliness?

• API

• Cleaning agent

• Microbes

• All of them

Which one of the following do not need to perform CV?

• Changing in manufactured product

• Changing in detergent

• Changing cleaning process

• Changing the equipment but same model

Selection of worst-case product according to PICS can be considered by ....

• Solubility

• Toxicity

• Cleanability

• All of them

Which one of these characteristics should be a worst-case product?

• High MACO

• Low LD50

• High water solubility

• Highest batch size

Which sampling method is not appropiate for large-scale manufacturing

equipment?

• Swab

• Rinsing

• Placebo

• None of them

Which level of contamination is determined as "visually clean"

• >0.4 mg/100 cm2

• <50 CFU/100 cm2

• <10 ppm

• <0.4 mg/100 cm2

The general acceptance limits of compound such as heavy metals that allow for contamination in products is .....

• 1%

• 10 ppm

• 1 ppm

• 0.4 ppm

Which terms are not related to calculation MACO using toxicity-based approach?

• No observed effect level (NOEL) of previous product

• Minimum batch size of next product (MBS)

• LD50 of previous product

• Therapeutic Daily Dose (TDD) of previous product

PIC/s Annex15, 2015 introducing MACO calculation based on toxicological data using .....

• Permitted Daily Exposure (PDE)

• Therapeutic daily dose (TDD)

• Minimum batch size (MBS)

• General acceptance limit