Quality System 2016 November 2016 GI
Quality System in
Pharmaceutical Industry
Compiled and Edited by Gunawan Indrayanto
Airlangga University, Faculty of Pharmacy
[email protected]
Surabaya, November 2016
For Seminar/educational purposes only, not for commercial
purposes
What is it mean by “Quality” ?
What Factors can affect “the Qualitydesign” of (Herbal) Drug preparations ?
Quality could be very “relative”!!
Cited from the Presentation of Prof. S. S. Handa, ICS-UNIDO, Bomaka, Mali 25-27 July, 200
COGS = Cost of goods solds
Aspects of Quality:
• Regulator
• Producer
• Costumers
http://www.pharmacompliancemonitor.com/the-six-subsystems-of-apharmaceutical-quality-system/4585/
Hazard Analysis Critical Control Point (HACCP)
API
meets
spec
Quality By Design – The
Pharmaceutical Industry
Feedback
loop
Manufacture
In process
testing
Excipients meet
spec
If fails,
understanding
/ root cause
and fix
QC testing
Acceptance
criteria based
on
performance.
Testing
Finished
Specs
Only confirms
quality – not
the place to
root cause
analysis and fix
For checking the quality of products,
we need validated methods of analysis
Regulation
Specification of the Producer
Quality Target Product Profile (QTPP)
Analytical Target Profile
QTPP and CQAs
QTPP components
Dosage Form
Route of administration
Strength
Weight
Pharmacokinetics
Appearance
Identity
Assay
Impurities
Content uniformity
Friability
CQAs
Assay (efficacy)
Impurities (safety)
C.U. (efficacy)
Dissolution
(efficacy)
Dissolution
Residual solvents
19
How to check the Quality of a
Product?
Quality must be evaluated by chemical analysis!
Production staffs and QA staffs “cannot see” the
quality of the products
CQA = Critical
Quality Attribute
Critical Method Attribute
ATP:
ll1.workcast.net/10311/.../MelissaHannaBrown_QbD_SepSci.pdf
(2014)
Elements of QbD
Quality Target Product Profile (QTPP)
Define Critical Quality Attributes (CQAs)
Perform risk assessment
Link raw material attributes and process parameters
to CQAs
Design and implement a control strategy
Manage product lifecycle, including continuous
improvement
29
II. HIT GENERATION
A) RESEARCH AND DEVELOPMENT
Process development – in phytopharmacy
Herbal raw material
Extraction solvent
Extraction
Miscella (Liquid raw
extract)
Dry extract
Tablets,
hard capsules
Liquid extract, tincture
Liquids, drops,
ointments
Encapsulatable
mass
Soft capsules
(H. Guenzler (1996), Accreditation and Quality Assurance in Analytical Chemistry, Springer,
Berlin).
A valid method must be proved that the
method is still valid for routine application
A valid method must be proved that the method is still valid for routine application
A valid method must be proved that the method is still valid for routine application
In order to determine the “Quality” of (Herbal) Drugs,
all chemicals (metabolites, heavy metals, pesticides, toxin)
must be evaluated (qualitatively and quantitatively).
Reliable and Validated
analysis’s methods are
needed !
E. Rozet, Ph. Hubert, Presentation University de Liege, Erasme, January 2012, reproduced with pe
Validation
Method
Calibrated
Instruments
Routine Analytical Method
Calibrated
Software
System
Suitability
Qualified Person
E. Rozet, Ph. Hubert, Presentation University de Liege, Erasme, January
2012, reproduced with permission
THANK YOU
Have a Great Day!!
Pharmaceutical Industry
Compiled and Edited by Gunawan Indrayanto
Airlangga University, Faculty of Pharmacy
[email protected]
Surabaya, November 2016
For Seminar/educational purposes only, not for commercial
purposes
What is it mean by “Quality” ?
What Factors can affect “the Qualitydesign” of (Herbal) Drug preparations ?
Quality could be very “relative”!!
Cited from the Presentation of Prof. S. S. Handa, ICS-UNIDO, Bomaka, Mali 25-27 July, 200
COGS = Cost of goods solds
Aspects of Quality:
• Regulator
• Producer
• Costumers
http://www.pharmacompliancemonitor.com/the-six-subsystems-of-apharmaceutical-quality-system/4585/
Hazard Analysis Critical Control Point (HACCP)
API
meets
spec
Quality By Design – The
Pharmaceutical Industry
Feedback
loop
Manufacture
In process
testing
Excipients meet
spec
If fails,
understanding
/ root cause
and fix
QC testing
Acceptance
criteria based
on
performance.
Testing
Finished
Specs
Only confirms
quality – not
the place to
root cause
analysis and fix
For checking the quality of products,
we need validated methods of analysis
Regulation
Specification of the Producer
Quality Target Product Profile (QTPP)
Analytical Target Profile
QTPP and CQAs
QTPP components
Dosage Form
Route of administration
Strength
Weight
Pharmacokinetics
Appearance
Identity
Assay
Impurities
Content uniformity
Friability
CQAs
Assay (efficacy)
Impurities (safety)
C.U. (efficacy)
Dissolution
(efficacy)
Dissolution
Residual solvents
19
How to check the Quality of a
Product?
Quality must be evaluated by chemical analysis!
Production staffs and QA staffs “cannot see” the
quality of the products
CQA = Critical
Quality Attribute
Critical Method Attribute
ATP:
ll1.workcast.net/10311/.../MelissaHannaBrown_QbD_SepSci.pdf
(2014)
Elements of QbD
Quality Target Product Profile (QTPP)
Define Critical Quality Attributes (CQAs)
Perform risk assessment
Link raw material attributes and process parameters
to CQAs
Design and implement a control strategy
Manage product lifecycle, including continuous
improvement
29
II. HIT GENERATION
A) RESEARCH AND DEVELOPMENT
Process development – in phytopharmacy
Herbal raw material
Extraction solvent
Extraction
Miscella (Liquid raw
extract)
Dry extract
Tablets,
hard capsules
Liquid extract, tincture
Liquids, drops,
ointments
Encapsulatable
mass
Soft capsules
(H. Guenzler (1996), Accreditation and Quality Assurance in Analytical Chemistry, Springer,
Berlin).
A valid method must be proved that the
method is still valid for routine application
A valid method must be proved that the method is still valid for routine application
A valid method must be proved that the method is still valid for routine application
In order to determine the “Quality” of (Herbal) Drugs,
all chemicals (metabolites, heavy metals, pesticides, toxin)
must be evaluated (qualitatively and quantitatively).
Reliable and Validated
analysis’s methods are
needed !
E. Rozet, Ph. Hubert, Presentation University de Liege, Erasme, January 2012, reproduced with pe
Validation
Method
Calibrated
Instruments
Routine Analytical Method
Calibrated
Software
System
Suitability
Qualified Person
E. Rozet, Ph. Hubert, Presentation University de Liege, Erasme, January
2012, reproduced with permission
THANK YOU
Have a Great Day!!