Quality by design
Lecture 1.1
Quality
= the ability to consistently produce the same product to meet the same specification time
after time
cGMP = current good manufacturing practice
→ regulations enforced by the FDA
→ assures quality by prescribing, documenting and inspecting ALL aspects of
pharmaceutical development and manufacturing
1902 Biologics control act → license needed, with license subject to inspection
1906 Pure food and drug act → truthful labeling e.g. being truthful about ingredients
Institutions
ICH = international conference on harmonization
US, Europe, Japan, etc. are working together to sync the rules for pharma
WHO = world health organization
regulator for countries that don’t hav3 their own system
National regulatory bodies
- US → FDA
- EU → REMA
- Japan → PFSB
Regulations for safe drugs
Q = quality → testing before bringing the product to the market
E = efficacy → the drug does what it is supposed
S = safety → reduction of toxicity risk
M = multidisciplinary → different parts of the product work together well
GxP systems
Think of intent (purpose), failure modes (what could go wrong), demonstrated evidence (how
to prove it went right)
★ Facility design (GEP)
★ Personnel training (SOP’s)
★ Laboratory Practices (GLP)
★ Clinical testing procedures (GCP)
★ Manufacturing procedures (GMP)
★ Manufacturing software design (GAMP)
★ Quality control and assurance (GQP)
★ Package and label design
★ Storage methods / cold chain management (GDP)
, GMP
➢ People → trained
➢ Premises → designated to GEP
➢ Equipment → maintenance, quality
➢ Procedures → documenten in sufficient detail
➢ Materials
➢ Storage and shipping → shipping conditions
Monitor and record everything
Design of a plant
★ Design
★ Prevention of build-up of dirt and dust to avoid unnecessary risk or contamination
★ effective cleaning and disinfection
★ Drain → prevent backflow
★ Protection from insect, birds, vermin and weather
Lecture 1.1
Quality
= the ability to consistently produce the same product to meet the same specification time
after time
cGMP = current good manufacturing practice
→ regulations enforced by the FDA
→ assures quality by prescribing, documenting and inspecting ALL aspects of
pharmaceutical development and manufacturing
1902 Biologics control act → license needed, with license subject to inspection
1906 Pure food and drug act → truthful labeling e.g. being truthful about ingredients
Institutions
ICH = international conference on harmonization
US, Europe, Japan, etc. are working together to sync the rules for pharma
WHO = world health organization
regulator for countries that don’t hav3 their own system
National regulatory bodies
- US → FDA
- EU → REMA
- Japan → PFSB
Regulations for safe drugs
Q = quality → testing before bringing the product to the market
E = efficacy → the drug does what it is supposed
S = safety → reduction of toxicity risk
M = multidisciplinary → different parts of the product work together well
GxP systems
Think of intent (purpose), failure modes (what could go wrong), demonstrated evidence (how
to prove it went right)
★ Facility design (GEP)
★ Personnel training (SOP’s)
★ Laboratory Practices (GLP)
★ Clinical testing procedures (GCP)
★ Manufacturing procedures (GMP)
★ Manufacturing software design (GAMP)
★ Quality control and assurance (GQP)
★ Package and label design
★ Storage methods / cold chain management (GDP)
, GMP
➢ People → trained
➢ Premises → designated to GEP
➢ Equipment → maintenance, quality
➢ Procedures → documenten in sufficient detail
➢ Materials
➢ Storage and shipping → shipping conditions
Monitor and record everything
Design of a plant
★ Design
★ Prevention of build-up of dirt and dust to avoid unnecessary risk or contamination
★ effective cleaning and disinfection
★ Drain → prevent backflow
★ Protection from insect, birds, vermin and weather
