Quality Management
Basic of Pharmaceutical
Management
Dr. Wuryanto Hadinugroho., [Link]., Apt.
Introduction
Quality Management
• The concept of individual & collective aspects effects the
quality of the product
• The totality of arrangement assurance the quality of product
& proper usege
• CPOB/GMP
2
Introduction
Quality Assurance (QA) : firmness of integrity of product quality
for consumers
Quality Control (QC) : aspect influence the manufacture of product
to meet quality spesification
Quality Management System (QMS) : management
system to arrange and control the organization to care quality
Quality Risk Management (QRM) : systematic
processes for appraisal, control, and assessment of product
quality risks
3
Introduction
Quality policy
Basic element
Quality
Quality
management
Vision & mission
of the industry
4
Element
Spesification :
assurance products meet
standard
Quality assurance :
totality of action
systematic
action
Organization :
QM department in industry
Element Resources :
personnel, technology,
water, energy
infrastructure/
system Procedure :
proccss step
5
QMS
appraisal, control, and
assessment
QRM
QMS
Giudeline QM element
CPOB, GMP, ICH systematic action
infrastructure/system
6
QRM
Evaluation
scientific & experience
QRM
Effort
action, formality, &
documented
7
Aspects
quality policy
process, procedures & instruction
objectives & spesification
Quality Plan
performance analysis
QP
systematic action
systemetic improvement
Quality Quality Assurance
Quality Improvement QI Management QA
systematic activities
trust
spesification
QC
Quality Control
monitoring, appraisal, & correction
process & product
spesification 8
Organization
Organizational Structure of Pharmaceutical Industry
9
Qualification
• bachelor, experienced, full time, master the quality of
manager infrastucture and pharmaceutical product
• bachelor, experienced, full time, master the quality of
leader infrastucture and specific pharmaceutical product
• diploma, fulltime, know the quality of
supervisior pharmaceutical product
analist • vocational high school/equal, fulltime
staff • high school/equal, fulltime
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Shift
Supervisior, Supervisior,
Analyst, Staff Analyst, Staff
Shift 3 Shift 1
(16.00-00.00) (00.00-08.00)
QC
Shift 2
(08.00-16.00)
Manager, Leader, Supervisior,
Analyst, Staff
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Scope of QC
grading of drug, dissolution,
viscosity
Laboratory
Enviroment Warehouse
wasted treatment status labeling
sampling of raw materials
Personnel
Engeenering Production
water treatment physical quality product
air treatment sampling product
Packaging
packaging quality product
sampling product 12
Scope of QC
quality of organoleptic,
physical, & grading
Raw materials
physical quality to strip,
blister, bottle. ampoule, & vial
Packaging Sample Semi-finished dosage form
quality of organoleptic,
physical, & grading to
granule/mass of tablets
Dosage form
quality of organoleptic, physical, &
grading to tablet/syrup/cream 13
Building
500 Lux
Lighting
Laboratory Room
Floor/table
Class room
coated
vinyl/epoxy/stainless steel min clean area
specification
Air conditoning (HVAC) Temperature
air exchange (12x/hour). 20 – 28 ˚C
negative presurre
Humidity (RH)
50%-30%
14
Building
neon/LED
Lighting
Office Room
Floor/table Class room
coated clean room
vinyl/epoxy/ceramic specification
stainless steel
Humidity (RH) Air conditoning (AC)
45%-64% 20 – 28 ˚C
15
Building
Laboratory Design
16
Control Equipment & Method
• DQ, IQ, OQ, PQ
• new equipment • all equipment
• requalification schedule • everday
• internal/supplier/vendor • internal
Calibration Qualification Validation Verification
• adjusments • analysis method
• new equipment • new method
• recalibration schedule • revalidation schedule
• internal/supplier/vendor • internal
Control of equipment & method
17
Control Raw Material/Packaging
• form
• qualitty • storage condition
• marking • method • security
• quarantine area • laboratory • position marking
• PPIC department • QC department • PPIC department
Reception Quarantine Sampling Test Status Relocation
• check quantity, • sample quantity • accepted/rejected
quality, • marking • marking
document • resealing • QC department
• PPIC • sampling area
department • QC department
Control of raw materials/packaging
18
Control Product
• accepted/rejected
• marking • marking
• staging • QC department
Sampling Quarantine Test
Next
Status
process
• quantity • physical quality • next step of production
• method • production deparment
• documention
• marking
• IPC • documention
• IPC/QC Lab.
Control of products
19
Role
Supplier Contractor
calibration, qulification, calibration, qulification,
& verification of & verification of facilities
equipment & building
Vendor
Production
• qulification of building,
QC equipment and facilities
QM • quality of raw materials, • validation of process &
product, & packaging. technology
• calibration, qualification,
Department & verification of facilities,
equipment, & building QA
• validation of analysis • storage of quality
Engineering document raw materials,
method
qulification of building, product, packaging
and facilities Purchasing • retain sample raw
qualification vendor of materials, product,
R&D PPIC packaging
raw materials,
quality of raw materials for stability of raw packaging, reagent, • customer complaints
formulation, technology, & materials, product, equipment, building, • products recall
analysis packaging facilities 20
Role
QM
Purchasing PPIC R &D/QC Production QC PPIC QA
Engineering
Department role for QM
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Basic of Pharmaceutical
Management
• EXIT • ENTER
Quality PPIC
• NEXT • NEXT
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