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MANTU SLIDE KULIAH 2020 Modul-5
MANTU SLIDE KULIAH 2020 Modul-5
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
WR-2-QM
INTRODUCTION
WR-3-QM
PROVISION OF FACILITIES AND RESOURCES
PROVISION OF FACILITIES
- License
- Access
- Premises
PROVISION OF RESOURCES
- Personnel
- Method (Specification, SOP, Form, Printed Materials)
- Machine
- Material
- Money
WR-4-QM
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
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
WR-5-QM PRODUCTION
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,
WR-6-QM
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
Fakultas Farmasi
Universitas Pancasila Jakata
WR-8-QM
C. GMP PROCESSES
7. Production
a. Principle
b. General
c. Raw Material
d. Process Validation
e. Prevention of Cross Contamination
WR10
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
WR10
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
WR10
C. GMP PROCESSES
WR10
C. GMP PROCESS
WR10
C. GMP PROCESS
WR10
C. GMP PROCESSES
WR-17-QM
THANK YOU
WR-18-QM