Quality in the pharmaceutical industry

Question 1

Is the product fit for purpose?

Answer 1

Expiry date
Seals
Pure (no contamination)
Damage
Effectiveness
Dosage
Information (Leaflets)

Question 2

How do you know your medication is safe?

Answer 2

Pharmacists
Medicine & Healthcare Regulatory Agency (MHRA)
Manufacturing & marketing authorisations

Question 3

Good manufacturing practice (GMP)

Answer 3

Orange guide
QC Synthesis- Cleaning residues, Checking raw materials, Contamination free
Documented methods that are validated
Analysis - competency of analysts lab
Product release by ‘Qualified person’

Question 4

Good distribution practice (GDP)

Answer 4

Consistent storage, transported and handled
Conditions defined in marketing authorisation
Green guide - rules and guidance for pharmaceutical distributors.