GOOD MANUFACTURING PRACTICES

Modul-1
Quality Management Fundamental Principles
Wayan Redja

Fakultas Farmasi Universitas Pancasila

Jakarta, 2014

Basic Principle of Management

DO IT RIGHT FROM THE FIRST TIME AND EVERY TIME

HOPE > QUALITY

Vision Mission, Goal, Objectives

MANAGEMENT

Quality Management

P
D

Activities, Resources

C
A

PLAN
DO
CHECK
ACT

Do what was written, write what is done

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

Productivity = output / input = effectiveness / efficiency

WR19

Quality Management
in
Good Manufacturing Practices
Quality Management Introduction, ISO 9000 Series, QMS ISO

9000, Product Realization in Pharmaceutical Industry, Quality

Management Principles, Quality Assurance Principles, Management
Review

Quality Management in GMP Introduction, GMP vs ISO 9000

Series, Quality Management System, Quality Assurance, Quality Risk

Management, Product Quality Review

GMP Essential Elements: Resources Introduction, Personnel,

Premises, Utilities, Equipment, Material, Documentation.

GMP Essential Elements: Processes, Introduction,

Qualification and Validation, Sanitation and Hygiene, Production,

Quality Control, Contract Manufacture and Analysis, Self Inspection
and Quality Audits, Handling of Complaint, Product Recall and
Returned Product
Waste Treatment Incinerator, Waste Water Treatment and Spec.

Quality Management

Introduction,
ISO 9000 Series,
QMS ISO 9000,
Product Realization in Pharmaceutical Industry,
Quality Management Principles,
Quality Assurance Principles,
Management Review

WR02

Introduction of Quality Management

Quality, System, Management, QM, QMS, QA,
GMP, QC, and QRM
Definition
Quality, System, Management, QM, QMS, QA,
GMP, QC and QRM
Interrelation of QM, QMS,QA, GMP, QC, QRM
Purpose of Quality Management
Purpose of GMP
WR02

Iroduction of Quality Management

Introduction
Quality, System, Management,
QM, QMS, QA, GMP,
QC, and QRM
Quality
General
- The ability
to fulfill requirements.
a
- Degree to which a set of inherent* characteristics fulfils
requirements.
*inherent = as opposed to assigned, permanent (ISO 9000)

Specific, i.e. product

- Degree to which the set of inherent characteristics of
the product fulfils the specifications.
GOOD QUALITY:
Effective & efficient > productive > fulfillment of requirements/spec. >satisfy > HAPPY

Introduction of Quality Management

Quality, System, Management, QM, QMS, QA,
GMP, QC, and QRM
System
Set of interrelated and interacting elements
The interacting element: organization structure, infrastructure,
resources, processes, documentation (quality manual,
specifications, SOPs, WI, forms, records, reports)

Introduction of Quality Management

Quality, System, Management, QM, QMS, QA, GMP,
QC, and QRM
Management*
- Coordinated activities, to direct and control an organization
- All those concerned in managing an industry, enterprise.

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)

Introduction of Quality Management

Quality, System, Management, QM, QMS, QA,
GMP, QC, and QRM
Quality Management*
- Management with regard to quality
- Coordinated activities, to direct and control an organization
with regard to the degree of inherent characteristics fulfill
the requirements.
*Quality Management (QM) consists of two elements, i.e.
Quality Management System (QMS) and Quality Assurance (QA)

Introduction of Quality Management

Quality, System, Management, QM, QMS, QA,
GMP, QC, and QRM
Quality Management System*
- System Management with regard to quality
- Set of interrelated and interacting elements of coordinated
activities, to direct and control an organization with regard
to the degree of inherent characteristics fulfill the
requirements.
The elements consist of:
organizational structure, processes, procedures, and
resources (5M: man, method, machine, material, money),

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)

# quality standards = specified quality = specification

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)

- Part of quality management focused on providing

confidence that quality requirements will be fulfilled.
(ISO 9000:2005)
WR04

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)

- Part of quality management focused on fulfilling

quality requirements.
(ISO 9000:2005)

WR-15-QM

QM in GMP
Interrelation of QM, QMS, QA, GMP, QC, Production,

QRM*
Y

*QRM = Quality Risk Management

Purpose and Goal of GMP

Purpose
To ensure the quality of products by diminishing the
risks inherent in pharmaceutical manufacturing
such as:
Cross-contamination,
Mix-ups (confusion),
Degradation,
Errors,
Health hazards

Purpose and Goal of GMP

Goal
> Good Quality Medicine
Three criteria of Quality Medicine ?

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)

Quality Management in GMP

GMP vs ISO 9000 Series
Quality Management System
Quality Assurance
Quality Risk Management
Product Quality Review

Catatan: Masukkan dalam Process Modul-5

- Product Realization
- Process Flow in Product Realization

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

The Main Principles of GMP

Processes are clearly defined and systematically reviewed to
assure consistent performance.
All necessary resources are provided:
- qualified trained personnel,
- adequate premises and space,
- suitable equipment and services,
- appropriate materials, containers and labels,
- approved procedures and instructions,
- suitable storage and transport,
- adequate personnel, laboratories, and equipment for IPC.
Qualification and validation are performed
Instructions and procedures are written in clear and unambiguous
language, applicable to the facilities provided.

The Main Principles of GMP

Operators trained to carry out procedures correctly.
Records are made during manufacture to assure instructions and
procedures have been done as expected, and deviations are fully
recorded and investigated.
Products are properly storage and distribute to minimize the risk of
quality.
Manufacturing and distribution records are retained in a
comprehensible and accessible form, for easy tracablility.
Product recall systems available.
Complaints are quickly handled, examined, investigated, and
appropriate measures taken to prevent recurrence.

QUALITY MANAGEMENT
QMS ISO Series 9000
QMS ISO 9000
Quality Management Principles ISO 9000
Quality Assurance Principles

WR09

Definition of
Introduction

Management, and Quality Management

Management (ISO 9000)

Coordinated activities to direct and control an organization.
Those activities consist of interrelated activities are known as
Management Functions, i.e. POAC (Planning, Organizing, Actuating,
and Controlling ) or PDCA (Plan, Do, Check, Act).

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

ISO 9001
International Standard
Voluntary
Any Organization
Quality Management
Requirements

GMP
National, Regional Standard
Compulsory
Manufacturing Organization
Quality Management &
Technical Requirements

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

Make quality people, before making quality product.
Quality People
Good attitude, Knowledgeable, Skillful

Quality must be build into the product.

: Do it right from the first time and every time
(POAC / PDCA)
Do what was written and write what is done.
The next process is our customer
5 NOs: Dont make, deliver, accept, keep, or use
bad quality product.
WR17

Quality Assurance Principles

POAC / PDCA
POAC (Management)

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

Process-based QMS of ISO 9000

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

Activity to transform input into output using resources

PDCA CYCLES Continual Improvement

Effectiveness

INPUT

PROCESS
RESOURCES, 5M

OUTPUT

Efficiency

Customer
Requirements

Customer
Satisfaction
Feedback

Value
adding
low

Information
flow

Productivity = output/input = effectiveness / efficiency

WR19

PRODUCT REALIZATION IN GMP

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

PPIC = Production Planning &

Inventory Control
PR = Purchase Request
Pcs = Purchasing
Rcv = Receiving
Qrt = Quarantine
Wgh = Weighing
Mix = Mixing
Fill = Filling Tab =Tabletting
Pkg = Packaging

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

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.
- The extent of effort, formality and the documentation of
the QRM should be equal to the potential opportunities
of the risk.

WR23

Quality Risk Management (QRM)

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

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