Escolar Documentos
Profissional Documentos
Cultura Documentos
Modul-1
Quality Management Fundamental Principles
Wayan Redja
MANAGEMENT
Quality Management
P
D
Activities, Resources
C
A
PLAN
DO
CHECK
ACT
IPC
Solve the problem
EVALUATE
Management Review
CAPA
CONTINUAL IMPROVEMENT
Process
Activity to transform input into output using resources
Efficiency
INPUT
PROCESS
RESOURCES, 5M
Customer
Requirements
Effectiveness
OUTPUT
Customer
Satisfaction
Feedback
Value
adding
low
Information
flow
Quality Management
in
Good Manufacturing Practices
Quality Management Introduction, ISO 9000 Series, QMS ISO
Quality Management
Introduction,
ISO 9000 Series,
QMS ISO 9000,
Product Realization in Pharmaceutical Industry,
Quality Management Principles,
Quality Assurance Principles,
Management Review
WR02
Organization
Group of people and facilities with an arrangement of responsibilities,
authorities and relationship.
Example: company, institution, association, etc.
* The definition of management implies the management functions, i.e.
POAC (Planning, Organizing, Actuating, Controlling)
Definition of
GMP, QA, QC, and Quality
GMP
- Part of Quality Assurance which ensures that products
are consistently produced and controlled to the quality
standards appropriate to their intended use and as
required by the marketing authorization.
(WHO, Technical Report Series, No.961, 2011)
Definition of
Introduction
GMP, QA, QC, and Quality
QA (Quality Assurance)
- QA is a wide-ranging concept covering all matters that
individually or collectively influence the quality of a
product. It is the totality of arrangements made with the
object of ensuring that pharmaceutical products are of
the quality required for their intended use.
(WHO, Quality Assurance of Pharmaceuticals, Vol.2, 2007, p.309)
Definition of
Introduction
GMP, QA, QC, and Quality
QC (Quality Control)
- QC coves all measures taken, including the setting of
specifications, sampling, testing and analytical
clearance, to ensure that raw materials, intermediates,
packaging materials, and finished pharmaceutical
products conform with established specifications for
identity, strength, purity and other characteristics.
(WHO, Quality Assurance of Pharmaceuticals, Vol.2, 2007, p.309)
WR-15-QM
QM in GMP
Interrelation of QM, QMS, QA, GMP, QC, Production,
QRM*
Y
QES
Quality Efficacy Safety
To assure the quality medicine appropriate to their
intended use until the medicine appropriately used by
the patient, Comprehensive QA (GMP, GSP, GDP,
GPP)* should be undertaken by the person in charge)
Coverage of GMP
Quality Management
Personnel
Premises
Equipment
Sanitation and Hygiene
Production
Quality Control
Self Inspection and Quality Audits
Handling of product Complaint, Product Recall, and
Returned Product
Documentation
Contract Manufacture and Analysis
Qualification and Validation
WR08
QUALITY MANAGEMENT
QMS ISO Series 9000
QMS ISO 9000
Quality Management Principles ISO 9000
Quality Assurance Principles
WR09
Definition of
Introduction
Quality Management
Management with regard to quality
Quality Management = QMS + QA
WR13
ISO 9001
ISO 9001
International standard of Quality Management System
Requirements, published by ISO.
It specifies requirements for a quality management
system.
To provide products that fulfill customer and
regulatory requirements.
To enhance customer satisfaction
# ISO The International Organization for Standardization, Geneva, Switzerland.
The members are the Standard Institutions of more than 160 countries including
Indonesia (BSN).
WR14
GMP
National, Regional Standard
Compulsory
Manufacturing Organization
Quality Management &
Technical Requirements
WR15
ISO 9000
Introduction
PDCA (worker)
Plan
- activities and resources.
Organize
- what are planed
Actuate
- what are organized.
Control
- what are actuated and
solve the problems
Plan
- the activity and the resources
Do
- what is planned
Check
- what is done
Act
- correct or report
the problem
CONTINUAL
IMPROVEMENT
Management
Responsibility
CUSTOMER
REQUIREMENTS
Resource
Management
Measurement
Analysis
Improvement
CUSTOMER
SATISFACTION
5
Product
Realization
INPUT
PROCESSES
3
Value-adding activities
OUTPUT
4
Information flow
WR18
Process
Effectiveness
INPUT
PROCESS
RESOURCES, 5M
OUTPUT
Efficiency
Customer
Requirements
Customer
Satisfaction
Feedback
Value
adding
low
Information
flow
Customer
Requirements
INPUT
Quality Management
Sanitation & Hygiene
Production
Quality Control
Self Inspection & Quality Audits
Claim Handling & Recall
Contract Manufacture & Analysis
Qualification & Validation
PROCESSES
RESOUCES
Personnel, Premises, Equipment,
Material, Documentation,
QA & QRM
Customer
Satisfaction
OUTPUT
MR = Marketing Request
PP = Production Plan
PO = Purchase Order
RM = Raw Material
IP = Intermediate Product
BP = Bulk Product
FP = Finished Product
IPC = In Process Control
QC = Quality Control
ST = Stock
PROCESS FLOW
IN GMP
MR/ST
PPIC
PP/PR
I PC / QC
Pcs
RM
RM
PO
Pcs
Rcv, Qrt
IP
Wgh > Mix Qrt
IP
BP
Fill,Tab
PROCESSING
PRODUCTION
MANUFACTURING: GMP
FP
BP
Qrt
Pkg
PACKAGING
FP
Qrt
WR22
Principles
- Evaluation of product quality is based on scientific
knowledge and process experiences in: R&D, GMP,
and product life-cycle focused on patient safety.
- The extent of effort, formality and the documentation of
the QRM should be equal to the potential opportunities
of the risk.
WR23
Methodology
- HACCP (Hazard Analysis of Critical Control Point)
- SOP on evaluation and risk handling
- Quality audit
- Annual product review
- Trend analysis
WR25
Input
Risk
Analysis
Risk
Elimination
Risk
Acceptance
Output
Risk
Review
Risk
Evaluation
RISK
EVALUATION
RISK
CONTROL
RISK
REVIEW
WR26
CONCLUSION
Do it right from the first time and every time is the key
success factor in building quality into the product.
The success of Quality Management implementation
depends on: commitment, competency, conducive
environment, and consistent implementation of the
quality management principles.
GMP is QA in manufacturing
Risk management should be consider to avoid errors
due to inconsistent implementation of GMP.
WR27