Quality System in
Pharmaceutical Industry
Compiled and Edited by Gunawan Indrayanto
Airlangga University, Faculty of Pharmacy
gunawanindrayanto@yahoo.com
Surabaya, November 2016
What Factors can affect “the
Quality-design” of (Herbal) Drug preparations ?
Aspects of Quality:
•
Regulator
•
Producer
•
Producer
Quality By Design – The
Pharmaceutical Industry
Manufacture In process testing
QC testing Finished Specs
API
meets
spec
Feedback
loop
Excipients meet
spec
If fails,
understanding
/ root cause
and fix
Acceptance
criteria based
on
performance.
Testing
Only confirms
quality – not
the place to
root cause
analysis and fix
For checking the quality of products,
Regulation
Specification of the Producer
Quality Target Product Profile (QTPP)
QTPP and CQAs
QTPP components
Dosage Form
Route of administration
Strength Weight
Pharmacokinetics Appearance
CQAs
Assay (efficacy)
Appearance
Identity Assay
Impurities
Content uniformity
Friability
Dissolution Residual solvents
19
Assay (efficacy)
Impurities (safety)
C.U. (efficacy)
Dissolution
How to check the Quality of a
Product
?
Quality must be evaluated by chemical analysis!
Production staffs and QA staffs “cannot see” the
Quality Target Product Profile (QTPP)
Define Critical Quality Attributes (CQAs)
Perform risk assessment
Link raw material attributes and process parameters
Elements of QbD
Link raw material attributes and process parameters
to CQAs
Design and implement a control strategy
Manage product lifecycle, including continuous
improvement
Process development – in phytopharmacy
Herbal raw material
Extraction solvent
Extraction
Miscella (Liquid raw
II. HIT GENERATION A) RESEARCH AND DEVELOPMENT
Miscella (Liquid raw
extract
)
Encapsulatable
mass
Dry extract
Liquid extract, tincture
Soft capsules
Liquids, drops,
ointments
Tablets,
A valid method must be proved that the method is still valid for routine application method is still valid for routine application
