QUALITY MANAGEMENT

GMP FOR PHARMACEUTICAL PRODUCT (CPOB)

Modul-5
GMP PROCESSES
Wayan Redja
Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2020
 C. GMP PROCESSES
INTRODUCTION
PRODUCTION
QUALITY CONTROL
SELF INSPECTION, QUALITY AUDIT,
SUPPLIER AUDIT & APPROVAL
HANDLING OF PRODUCT COMPLAIN &
RECALL
CONTRACT MANUFACTURE & ANALYSIS
QUALIFICATION & VALIDATION

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 INTRODUCTION

PROVISION OF FACILITIES AND

RESOURCES
RESOURCE MANAGEMENT ACTIVITIES
MANUFACTURING CYCLE
GMP PROCESS FLOW

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PROVISION OF FACILITIES AND RESOURCES

PROVISION OF FACILITIES
- License
- Access
- Premises
PROVISION OF RESOURCES
- Personnel
- Method (Specification, SOP, Form, Printed Materials)
- Machine
- Material
- Money

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 RESOURCE MANAGEMENT ACTIVITIES
MARKETING PPIC PURCHASING WAREHOUSE
1Yearly 1 Yearly Yearly Purchasing 7 Material
Forecast Prod. Plan Matr. Need Process Receiving
2
6
8
Stock
Material
Budget
Stock

Roling 1 Periodic Periodic

Forecast Prod. Plan Stock Plan
3

1 6 9
Monthly>Weekly>Daily
Prod. Plan Production
Process
4 5
Production Material
7 10
Order Request
5 Batch
Record
Material Prod.
Control Control
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 MANUFACTURING CYCLE

1a 1
R&D MARKETING
2a

CUSTOMER
2
2b
SUPPLIER

4a 3a
PURCHASING PPIC 6a QC
4 6
3

5a 5 7
WAREHOUSE PRODUCTION QA
8
# Technical Engineering Department: Service
10 and maintenance of the machines 9
# TE and the operation of utilities.

.A. Stock Available 1. Customer Requirement > 2. Marketing Forcast > 3. Inventory Control > 4. Job Order
> 5 . Processing / IPC > 6. QC > Packaging,/ IPC > 7. QA Batch Record Verification &
Feedback for CQI > 8. Storage > Distribution to Customer > 10. Outcome for CQI.
B. No Stock : 3a. Purchasing material > 4a. PO > 5a. Receiving > 6a. QC Release > As A from 4 etc.
C. New Product : 1a Marketing Request > 2a R&D information to PPIC > R&D > 2b Up Scaling
production and Validation > Registration > Commercial Production after marketing
authorization,
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 GMP PROCESS FLOW
CR = Customer requirement PR = Purchasiing Request Qrt = Quarantine IP = Intermediate Product
MR = Marketing Request Pcs = Purchasing IPC = In Process Control Fill = Fillingor or Tab
ST = Stock, PPIC = Production PO = Purchase Order QC = Quality Control =Tabletting
Planning & Inventory Control RM = Raw Material Wgh = Weighing, Mix = Mixing BP = Bulk Product
PP = Production Plan Rcv = Receiving PW = Pharmaceutical Whollesaler Pkg = Packaging
FP = Finished Product
GMP > QM > QUALITY ASSURANCE > QMS - FP

CR GDP & FEEDBACK . > CAPA > CONTINUAL IMPROVEMENT

PBF
(PW) MR ST QUALITY CONTROL (Lab control} > Production Process (I PC)
PPIC
PR PP PM
Pcs
PO RM RM RM IP IP / BP BP FP FP
Rcv /Qrt Wgh Mix Qrt Fill /Tab Qrt Pkg Qrt
PLANNING STORAGE PROCESSING > Wgh – Fill/Tab PACKAGING > BP - FP
PRODUCTION > Rcv - Pkg

MANUFACTURING > Pcs - Pkg

 OPERATION MANAGEMENT
IN PHARMACEUTICAL INDUSTRY
Wayan Redja

Fakultas Farmasi
Universitas Pancasila Jakata

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 C. GMP PROCESSES

7. Production
a. Principle
b. General
c. Raw Material
d. Process Validation
e. Prevention of Cross Contamination

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 C. GMP PROCESSES

7. Production (Continuation)
f. PPPIC
g. Purchasing
h. Receiving
i. Processing including Weighing and
Dispensing
j. Packaging and Batch / Lot Numbering
System
i. Solid Material and Product
k. Distribution
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 C. GMP PROCESSES

8. Quality Control
a. Principle
b. General
c. GLP
d. Documentation
e. Sampling
f. Testing
g. Testing Requirement
h. On-going Stability Program
i. Solid Material and Product
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 C. GMP PROCESSES

9. Self Inspection,Quality Audit,

Supplier
Audit & Approval
a. Principle
b. Quality Audit
c. Supplir Audit & Approval

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 C. GMP PROCESS

10. Handling of Product Complaint and

Recall
a. Principle
b. Poduct Complaint
c. Product Recall

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 C. GMP PROCESS

11. Contract Manufacture and Analysis

a. Principle
b. General
c. Contract Giver
d. Contract Receiver
e. Contract

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 C. GMP PROCESSES

12. Qualification and Validation

a. Principle
b. Planning
c Documentation
d. Qualification
e. Process Validation
f. Cleaning Validation
g. Change Control
h. Revalidation
i. Analytical Method Validation
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 E. ANNEX OF GMP (CPOB)
 Annex
1. GMP for Active Pharmaceutical Ingredient
2. GMP of Sterile Peoduct
3. GMP of BiologicalMaterial and Product for
Human Use
4. GMP of Blood Product
5. GMP of Investigational Product
6. GMP of Presurized Measured Dose Inhalation
7. GMP of Medicinal Gas
8. GMP of Radiofarmaca
9. The Use of Ionizer Iradiarion in Drug Manufacturing
10, Quality Risk Manajemen
11. Real Time and Parametric Release
12. Reference Sample and Retained Sample
13. Real Time and Parametric Release Test.
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 ASSIGNMENT
1. What is the definition of process? Illustrate it in a diagram.
2. What is an effective and efficient process?
3. Why the process must be effective and efficient?
4. How to run the process effectively and efficiently?
5. Are the processing, production, and manufacturing the same process
or not? Explain the definition of the each term!
6. What does it mean by hygiene and sanitation?
7. Why hygiene and sanitation requirement must be fulfilled in GMP?
8. Describe the difference of the function of QA, QC and Production
Department?
9. What is the definition of Qualification and Validation?
10. Present in a table the analytical method category and analytical
parameter that must be validated in Analytical Method Validation.

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THANK YOU

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