Webinar 0723

In which part of CPOB 2018, cleaning validation clause is described?

• Chapter 5

• Chapter 7

• Chapter 12

• Appendix

Calculation of PDE based on BPOM expectation should be done by?

• Qualified Toxicologist

• Qualified person that has experience in determination of HBEL

• Outsourced to third-party

• All is correct

Product marker should be determined on the following, except?

• Ease of cleaning

• Toxicity
• Production frequency
• Solubility

PDE can be determined based on below, except?

• NOEL
• LOAEL
• NOAEL
• LD50

Correction factor that extrapolates variation between species to calculate PDE is represents by:

• F2
• F3
• F4
• F1

MACO should be determined based on below, except?

• PDE

• Minimum batch size of product contaminant
• Minimum batch size of next product manufactured

• Maximum Daily Dose of the next product to be manufactured

Herewith components needed to calculate safety limit, except?

• Surface sampling area

• Total surface area

• MACO

• PDE

The following are factors to be considered in TACT:

• Time – Action – Chemical Concentration – Temperature

• Task – Action – Chemical Concentration – Temperature

• Time – Action – Chemical Concentration – Thermometer

• Time – Assembly – Chemical Concentration – Temperature

Herewith are sampling method to check chemical residue:

• RODAC

• Conductivity

• Swab & Rinse

• None is correct

If company do not have ability to check specific API residue, parameter that can be selected according to CPOB 2018 is:

• HPLC

• GC

• TOC
• AAS