Webinar 1510

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

These are the aspect to be fulfilled in clause of Organization, Management and Personnel, except?

• Organization Structure

• Vision and Mission

• Job Descriptions

• Training Programs

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

These are aspects mandatorily to be discussed during Quality Management Review, except

• Company Quality Objective

• Company Quality KPI

• Company Profit

• Trend of Quality Complaints

Temperature Mapping is mandatory to be done on this storage area:

• Cool Storage

• Chiller Storage

• Ambient Storage

• All is correct