CDA 29/06

Which of the following factors are considered positive during the FDA Readiness Assessment?

• High motivation of personnel

• Visible improvements since last assessment

• Experience in manufacturing of biologics

• Perfect interaction with FDA assessor achieved

Which systems of 3P did the assessment cover? Select the WRONG answer.

• • Warehousing

• • Material Management

  
  

• • Quality Control

  
  

• • None of the previous FDA Inspection and Responses

  
  

• • Quality Assurance and Quality Systems

What is the point of the assessment?

• Improving gaps in order to be eligible for FDA approval

• Criticizing 3P personnel

• Covering up deficiencies in procedures & PNTs

• Downplaying achievements

Select what can be improved regarding WAREHOUSING:

• Incoming bay used as official storage location

• • Ongoing Implementation of SAP

• • Use of Goods Receipt Checklist/Logbook

• Damaged materials docuemnted as "OK"

Select what was considered positive regarding WAREHOUSING:

• • Use of Goods Receipt Checklist/Logbook

• • Implementation of SAP Completed

• New sampling area

• • Warehouse wall is wet, shows traces of mold

Select what can be improved regarding MATERIAL MANAGEMENT:

• • Need Quality Agreements and Audits for Suppliers

• • Use of Risk-based approach

• • Supplier Audits which were done acceptable

• Unclean dispense area when status said "clean"

Select what was considered positive within MATERIAL MANAGEMENT:

• • Use of Risk-based approach

• • System for Supplier Quality Oversight

• Quality Agreements and Audits for Suppliers

• Use of Risk-based approach

What aspect was considered positive regarding PREMISES, UTILITIES and EQUIPMENT:

• Significant Mold trend in the facility

• Micro control strategy

• VMP, no VMP approval by Senior Management

• • Investments, like new QC, new Water Loop (kept at 80C)

What aspect was considered to be missing or need improvements regarding PREMISES, UTILITIES and EQUIPMENT:

• Significant Mold trend in the facility

• Micro control strategy

• VMP, no VMP approval by Senior Management

• • Investments, like new QC, new Water Loop (kept at 80C)

What aspects are considered positive regarding MANUFACTURING:

• • Good process knowledge

• Gowning concept

• Amount of Samples taken in Process

• Commercial Manufacturing Processes flexibly adapted between batches