quality control

Question 1

quality control?

Answer 1

process used to ensure a defined level of quality in a product –> reproducible and fit for use

Question 2

regualtions

Answer 2

• Directive 2003/94/EU
• 21 CFR 211.22
• EudraLex = Vol 4 Part 1 Chapter 6

Question 3

Directive 2003/94/EU

Answer 3

describes activities in GMP that’s conducted by QUALITY UNIT
- Quality assurance system
- personnel - qualified
- documentation - trace history of each batch
- outsourced work - written contract between SU and RU - QUALITY ASSURANCE RESPONSIBLE
- complaints and product recall - QUALITY ASSURANCE RESPONSIBLE
- Self inspection - QUALITY ASSURANCE RESPONSIBLE

Question 4

quality control laboratories

Answer 4

• separate from production
• control labs designed to suit operations being carried out in them
• seperate rooms for sensitive material
• special requirements for labs handling particular substances

Question 5

roles of QC labs

Answer 5

1. suppliers evaluation
2. setting specification
3. sampling of raw materials
4. testing
   - raw
   - packaging
   - finished
5. controlling documentation
6. pharmacovigilance