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Below is the scope of the GDP, except?

• Distribution

• Post Market

• Transportation

• Product Development

Below is the benefit of implementing GDP, except?

• Evidence of adherence to legal regulations and requirements

• To manage and minimize risk

• To improve performance

• To increase quality cost

Below are the GDP clause that is available in Medical Device but not in pharmaceutical products:

• Secondary Assembly

• Quality Management System

• Premises and Facility

• Inspection

Current regulation of GDP for Medicine in Indonesia:

• Per BPOM 6/2020

• Per BPOM 20 / 2025

• Per BPOM 20 / 2020

• Per BPOM 6 / 2025

This system should be implemented during storage and handling:

• FIFO

• FEFO

• Stock Check

• All method is applicable/required

Below is all documentation required in GDP

• A. SOP

• B. MSDS

• C. SMF

• D. All is correct

Post Marketing Surveillance are described in below activities, except:

• Fraud

• Counterfeit

• Complaint

• Adverse Event

Minimum period of Self Inspection to be done is:

• Once a month

• Once per semester

• Once a year

• Twice a year

New clause added in current Indonesia CDOB on Chapter X for Drug Substances is:

• A - Repackging and relabelling

• B - Handling Non-Conforming Product

• C - Documentation

• D - Delivery of Information

New scope added to Chapter XII?

• Narcotics

• Precursor

• Psychotropics

• Other Drugs that often misuse