Professional Documents
Culture Documents
Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2018
GOOD MANUFACTURING PRACTICES
FOR PHARMACEUTICAL PRODUCTS
Introduction
Quality Management
Resources and Critical Supporting
Facilities
Processes
WR01
Introduction
Definition
Purpose
Why and How to implement GMP?
Principles of GMP
Classification of Errors in GMP
GMP vs ISO 9001
Coverage of GMP
WR02
Introduction
Definition of 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)
# quality standards = specified quality = specification
Purpose of GMP?
To ensure the quality of products by eliminating the
nonconformance in the implementation of GMP
such as:
Cross-contamination,
Mix-ups (confusion),
Degradation,
Errors,
Health hazards
WR04
Introduction
Goal
> Good Quality Medicine
QES
Quality Efficacy Safety
To assure the quality medicine appropriate to their
intended use until the medicine appropriately used by
the patient, Total QA (GMP, GSP, GDP, GPP)* shoulld
be undertaken by the person in charge)
*Person in Charge: Medical Doctor, Pharmacist, Patient
WR05
Introduction
Why GMP?
- Government regulation
- QA of drug
WR07
The Main Principles of GMP
Processes are clearly defined and systematically reviewed to assur
e consistent performance.
1. Cross Contamination
2. Degradation of Quality
3. Mix-up
4. Other Errors
5. Health Hazard
WR08
Introduction
ISO 9001 vs GMP
WR09
Introduction
Coverage of C. Processes
GMP 6. Sanitation and Hygiene
7. Production
A. Management 8. Quality Control
9. Self Inspection, Quality
1. Quality Management
Audit, Audit and Vendor
Approval
B. Resources 10. Handling of Product
2. Personnel Complaint and Product
3. Premises and Recall
Facilities 11. Contract Manufacture and
4. Equipment Analysis
5. Documentation 12. Qualification and Validation
WR10
Modul - 3
GMP: Introduction
MR = Marketing Request PPIC = Production Planning &
PP = Production Plan Inventory Control
GMP PROCESS FLOW PO = Purchase Order
RM = Raw Material
PR = Purchase Request
Pcs = Purchasing
IP = Intermediate Product Rcv = Receiving
BP = Bulk Product Qrt = Quarantine
FP = Finished Product Wgh = Weighing
MR/ST IPC = In Process Control Mix = Mixing
QC = Quality Control Fill = Filling Tab =Tabletting
ST = Stock Pkg = Packaging
PPIC
PP/PR QA
Pcs I PC / QC
PO RM RM IP IP BP BP FP FP
Pcs Rcv, Qrt Wgh > Mix Qrt Fill,Tab Qrt Pkg Qrt
PROCESSING PACKAGING
PRODUCTION
MANUFACTURING: GMP
Process
Activity to transform input into output using resources
Efficiency Effectiveness
INPUT PROCESS
OUTPUT
RESOURCES, 5M
Value
adding
low
Customer Customer
Requirements Satisfaction Infor-
Feedback mation
flow
Basic Elements
> Quality Management System
> Quality Assurance
> GMP: Production , QC, etc.
> Quality Risk Management
> Product Quality Review
> Quality Management Review:
QMS, QA, GMP, QRM
Quality Management
Interrelation of QM, QA, GMP and QC
QM
QA
GMP
QMS R&D QC PRD
WR02
GMP Quality Management
WR04
Quality Management
Quality Assurance
Coverage: All matters of PDCA cycle in R&D, Production,
Quality Control.
Authority and Responsibility in GMP
> Qualification and Validation > Change control
> Production & QC > Quality Risk Management
> Product Release > Product Quality Review
> Audit (internal & external) > Quality Management Review
> Nonconformance handling
Pinciple
Build quality into the product
Quality Management
Production
Part on GMP focus on producing the
right quantity of quality product at the
right time as planned.
Quality Control
Part of GMP or QA focus on testing of
materials, products and environment
to fulfill quality requirements.
Basic Principle
Do what is written and write what is done!
Quality Management
Product Release
Chek
> Bach Production Record (Processing & Packaging)
> COA
> Marketing authorization document
> Retained Sample
Report
> Product Release & Reject Chek List
> Release or Reject Label
> File: Original (Head of QA), Copy ( QA staff)
Report of Nonconformance
General
Nonconformance Test Results
(HULS)
Production
Contamination
Equipment
Critical
Nonconformance Handling
Purpose
Coverage
Responsible Person
Forms
Procedure
Documentation Distribution
Change Control
Purpose
Coverage
Responsible Person
Forms
Procedure
Documentation Distribution
Product Quality Review
Purpose
Coverage
Responsible Person
Procedure
Documentation Distribution
Quality Risk Management
General Process
Risk
Identification
Risk
Elimination
Risk
Input
Analysis
Risk Risk
Output
Acceptance Review
Risk
Evaluation
RISK
REVIEW
RISK RISK
EVALUATION CONTROL WR26
Quality Risk Management
Definition
Principles
Objectives
Coverage of Application
Methodology
Process Procedure
WR22
Quality Risk Management (QRM)
Definition
Systematic process on evaluation, control, and review of
product quality risk
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.
WR25
CONCLUSION
Do it right from the first time and every time is the key su
ccess factor in building quality into the product.
GMP is QA in manufacturing
WR27
THANK YOU
WR-33-QM
The Main Principles of GMP
Processes are clearly defined and systematically reviewed to assur
e consistent performance.
WR09
Definition of
Introduction
Management, and Quality Management
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
ISO 9001 vs GMP
WR15
ISO 9000
Introduction
Quality Management Principles
Customer focus
Leadership
Involvement of people
System approach to management
Process approach
Factual approach to decision making
Mutually beneficial supplier relationship
Continual improvement
WR16
Quality Assurance Principles
1 Measurement
Resource CUSTOMER
Analysis
Management SATISFACTION
Improvement
5
Product
Realization
INPUT OUTPUT
2 PROCESSES
3 4
Effectiveness
PROCESS
INPUT OUTPUT
RESOURCES, 5M
Value
Efficiency adding
low
Customer Customer
Requirements Satisfaction Infor-
Feedback mation
flow
Quality Management
Sanitation & Hygiene
Customer Production Customer
Requirements Quality Control Satisfaction
Self Inspection & Quality Audits
Claim Handling & Recall
Contract Manufacture & Analysis
Qualification & Validation
RESOUCES
Personnel, Premises, Equipment,
Material, Documentation,
QA & QRM
MR = Marketing Request PPIC = Production Planning &
PP = Production Plan Inventory Control
PO = Purchase Order PR = Purchase Request
MR/ST
PPIC
PP/PR
I PC / QC
Pcs
PO RM RM IP IP BP BP FP FP
Pcs Rcv, Qrt Wgh > Mix Qrt Fill,Tab Qrt Pkg Qrt
PROCESSING PACKAGING
PRODUCTION
MANUFACTURING: GMP
MODERN CHAIR
Quality Risk Management
Definition
Principles
Objectives
Coverage of Application
Methodology
Process Procedure
WR22
Quality Risk Management (QRM)
Definition
Systematic process on evaluation, control, and review of
product quality risk
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.
Objectives
- Establish more understanding on the process and
product
- Establish and maintain a state of control
- Support better quality assurance of product quality
- Achieve product realization
- Effective and consistent decision making on CAPA
- Provide higher confident to achieve patient safety
- Facilitate continual improvement of quality
WR24
Quality Risk Management
Coverage of Application
- R&D
- Commercial manufacturing (Resources, processing,
QC, packaging, label, stability test, storage, distribution)
- Product discontinuation ( Effective management of the
terminal stage of the product lifecycle).
Methodology
- HACCP (Hazard Analysis of Critical Control Point)
- SOP on evaluation and risk handling
- Quality audit
- Annual product review
- Trend analysis
WR25
Quality Risk Management
General Process
Risk
Identification
Risk
Elimination
Risk
Input
Analysis
Risk Risk
Output
Acceptance Review
Risk
Evaluation
RISK
REVIEW
RISK RISK
EVALUATION CONTROL WR26
CONCLUSION
Do it right from the first time and every time is the key su
ccess factor in building quality into the product.
GMP is QA in manufacturing
WR27