Parenteral Products Manufacturing

All rights reserved by the Presenter
Tuesday, March 8, 2016
Modern
concept of
Pharmaceutica
l Factory
Sterile
Division
Operations
Presenter: Md Salim Jahangir, B-Pharm( Hons), M-Pharm(DU),

MBA, ISO QMS Lead Auditor, Pharmaceutical Consultant
All rights reserved by the
Presenter
RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY
STORE
RECEIVING
RECEIVING FROM
PRODUCTION
QUARANTINE
RAW MATERIAL
APPROVED MATERIAL
STORAGE
MATERIAL ISSUE
FINISHED PRODUCT
DISTRIBUTION
RECEIVING
RECEIVING
PACKAGING
MATERIAL
QUARANTINE
APPROVED MATERIAL
STORAGE
MATERIAL ISSUE
QUARANTINE
ENGG. GOODS
STORAGE
MATERIAL ISSUE

PRODUCTION UNIT 1
GENERAL PRODUCTS
PROCESS
TABLET
(NON-ANTIBIOTIC)
COMPRESSION
DRY SYRUP
(NON-ANTIBIOTIC)
PROCESS
FILLING & SEALING
PACKING
COATING
BLISTERING
PACKING
PROCESS
TOPICAL
CREAM &
OINTMENT
(NON-STEROID)
FILLING & SEALING

PACKING
PROCESS
CAPSULE
(NON-ANTIBIOTIC)
FILLING
( ENCAPSULATION)
BLISTERING
PACKING
PROCESS
ITOPICAL
CREAM &
OINTMENT
( STEROID)
FILLING & SEALING

PACKING

QUALITY ASSURANCE
SAMPLING
Q. C
(INSTRUMENTAL
& CHEMICAL)
SAMPLING
TESTING
DOCUMENTATION
MICROBIOLOGY
IPQC
TESTING (STERILITY &

MICROBIAL
CONTAMINATION)
DOCUMENTATION
INSPECTION
PLANNING
PRODUCT
DEVELOPMENT
PREPARATION
REPORTING
DOCUMENTATION
QUALITY
ASSURANCE
DATA ANALYSIS
COMPLIANCE
VALIDATION

ENGINEERING & MAINTENANCE
POWER
MECHANICAL
STEAM
WORKSHOP &
FABRICATION
MACHINE RY &
EQUIPMENTS
MAINTENANCE
HVAC
UTILITY SERVICES,
BMS, ETP &
CIVIL WORKS
WATER
GAS, FUEL &
LUBRICANT
AIR CONDITIONING
& CHILLER
ELECTRICAL
MACHINERY &
EQUIPMENTS
BUILDING, POWER
GENERATION &
DISTRIBUTION
COMPUTER,
SOFTWARE &
ELECTRONICS
MACHINERY &
EQUIPMENTS
SECURITY SYSTEM
COMPUTER
NETWORKING, ERP
& COMMUNICATION
PRODUCTION MANAGEMENT
FINANCE & ACCOUNTING
FACTORY OFFICE
QUALITY MANAGEMENT
SECURITY
HUMAN RESOURCE &
ADMINISTRATION
DISTRIBUTION OF
FINISHED GOODS
All rights reserved by the
PHARMACEUTICAL
FORMULATION
PRODUCTS
Presenter
Tuesday,
March 8, 2016
10
WASHING & DRESSING FACILITY AT EN FTRY IS

MANDATORY FOR PHARMACEUTICAL FACTORY
11
12
13
CLEAN DRESS IS THE PRIME COMPONENT OF PERSONNEL

PROTECTION IN PHARMACEUTICAL FACTORY
14
CLEAN DRESS IS THE PRIME COMPONENT OF PERSONNEL

All rights reserved
by the Presenter
Tuesday,
March 8, 2016
PROTECTION
IN PHARMACEUTICAL
FACTORY
15
PERSONNEL ENTRY TO PRODUCTION AREA IS UNDER STRICT

All rights
by the
Presenter
Tuesday,
March
8, 2016 DRESSES
CONTROL SUBJECT
TOreserved
CHANGE
OF
& WEARING
OF
STERILE
16
AllENTRY
rights reserved
the Presenter
Tuesday,
March 8, 2016
TObyPRODUCTION
AREA
17
PERSONNEL ENTRY
THROUGH AIRLOCK
Tuesday,
March 8, 2016
SYSTEM
19
PHARMACEUTICAL FACTORY CLEANING IS THE INTEGRAL

All rights reserved
by the Presenter cGMP
REQUIREMENTOF
21
PRODUCTION CORRIDOOR OF PHARMACEUTICAL FACTORY

22
PHARMA CEUTICAL FACTORY MANUFACTURING AREA

23
24
25

PHARMACEUTICAL
FACTORY
HVAC SYSTEM
26
27
28
29
30
REVERSE OSMOSIS
WITH
EDI HIGHLY
PURIFIED
WATER
MANUFACTURING
PLA
All rights
reserved
by the Presenter
Tuesday,
March
8, 2016
31
All rights reserved

by the Presenter
March 8, HIGHLY
2016
WATER FACILITY, MULTI-COLUMN
DISTILLATION
PLANTTuesday,
TO PRODUCE
PURIFIED
32
WATER
PURIFIED WATER 24 HOURS CIRCULATING LOOP SYSTEM AT 85 0 C.

33
HVAC CONTROL
SYSTEMbyISthe
A PART
OF BMS
All rights reserved
Presenter
34
All rights reserved

by the
Presenter
Tuesday,
March
2016 SYSTEM
AHUs AND DEHUMIDIFIERS
ARE
THE
INTEGRAL
PART
OF8,HVAC
35
RAW MATERIAL ARE PROCURED FROM WORLD RENOUNED

EUROPEAN SOURCES UNDER THE LEADERSHIP
OF VERY EXPERIENCED HIGHLY QUALIFIED HEAD OF PROCUREMENT
All rights reserved&
byPLANNING
the Presenter
36
FLOW DIAGRAM OF STORAGE FACILITY & ISSUE SYSTEM

RAW & PACKING MATERIAL
(Planning & Information Control)
Receiving of Raw
Material
Quarantine of Raw
Material
Issue of Raw Material against D.A

Approved formulation order under
the Supervision of production
pharmacist & checking by QA
inspector
Manufacturing
of
Product
under
supervision of production pharmacist in a
controlled area certified by QA
Sampling of Raw
Material
Release of Raw Material

by QA Department &
Storage in Approved
Material Area
Intermediate Product
(IPQC by Quality
Assurance)
Quarantine of Packing Material

Receiving of Packing
Material
Issue of Packing Material against
Release of Packing
D.A Approved formulation order
Material by QA
under the Supervision of
Department & Storage in
production pharmacist & checking
Approved Material Area
by QA inspector
Manufacturing of Product under
supervision of production
pharmacist in a controlled area
certified by QA
Testing of Raw Material

by QC Department
Sampling of Packing Material
Testing of Packing
Material by QC
Department
Finished (Final) Product
37
FLOW DIAGRAM OF STORAGE FACILITY & ISSUE SYSTEM

RAW & PACKING MATERIAL
Receiving of Raw
Material
Quarantine of Raw
Material
Issue of Raw Material against D.A

Approved formulation order under
the Supervision of production
pharmacist & checking by QA
inspector
Release of Raw Material

by QA Department &
Storage in Approved
Material Area
Sampling of Raw
Material
Testing of Raw Material
by QC Department
Manufacturing
of
Product
under
supervision of production pharmacist in a
controlled area certified by QA
Quarantine of Packing Material

Receiving of Packing
Material
Issue of Packing Material against
Release of Packing
D.A Approved formulation order
Material by QA
under the Supervision of
Department & Storage in
production pharmacist & checking
Approved Material Area
by QA inspector
Manufacturing of Product under
supervision of production
pharmacist in a controlled area
certified by QA
Sampling of Packing Material
Testing of Packing
Material by QC
Department
De-cartoning of Bottles
Loading on online
Washing Machine
Trucking
Automatic Transferring
to washing zone through
Bottle conveyors
Automatic Washing of Bottles

with water for Injection (WFI)
prepared by multi-column
distillation plant coming from 24
hours circulating loop system at
80C
Sterilization & Depyrogenation (Endotoxin

freeing) of dried Bottles at
310C at Hot Zone
Drying of Bottles
at pre hot zone
Rapid Cooling &

Sterilization of Bottles
to 25C at cooling zone
Continuous records of temperature,

pressure, time of each zone on PLC
controlled panel with automatic
graphical recording
Filling-Sealing, Labeling & Packing of LVPL Bottle

Automatic Filling of Bottles with LVPL solution.
Automatic Stoppering of filled Bottles with sterile
rubber bungs under class 100 LAF surrounding class
1000,
Continuous monitoring of Volume variation and
environmental parameters temp (25C 2, RH 45% 2
and air pressure 50 pascals in filling point under LAF
class-100) Surrounded by class-1000 air pressure 30
pascals.
Spare parts, Dresses & rubber bungs are
sterilized at 121,15psg for 25 minutes in a
automatic most-heat sterilizer (Autoclave)
Sterilization of filled-sealed
Bottles
in
Moist
Heat
Sterilization
Machine(Autoclave) at 1210C
and 15 Lb Pressure for 30
Minutes.
Online labeling of filled

sealed Bottles under
Auto Labeling Machine
Capping of Stoppard Bottles

with sterile flip of seal under
LAF, class 100 surrounding
(class 1000.)
Inspection of filled-sealed
Bottles under online
Inspection Hood
Final packing of unit

cartons in master cartons
after proper checking &
QA release
PROCEDURE
The required quantity of Ampoules are received. Then De-Cartoned the

Ampoules and Loaded on online washing machine. Automatic Transferring
to washing zone through conveyors.
Automatic washing of Ampoules with WFI prepared by multi-column
distillation plant coming from 24 hours circulating loop system at 80C.
Drying of Ampoules at pre hot zone. Sterilization & De-Pyrogenation
(Endotoxin freeing) of dried Ampoules at 310C. Rapid Cooling of Ampoules
at
25C
cooling zone.
Transferring
the washed
sorted
Ampoules in
The
rawat
materials
are dispensed
according
to raw
material
sterilized trays.
requisition sheet.
Transfer required quantity of WFI from loop to the steam-jacketed covered washed and
sterilized processing vessel fitted with stirrer, in and outline nitrogen passing line and
transfer device. Add all weighed ingredients as per formulation sheet and order of
mixing. Then sampled by quality control for test release for filling.
Then transfer the solution from processing vessel to filling vessel through a
pump fitted with two stage cartridge filter (0.4 micron & 0.22 micron).
The sterilized SVPL solution (by microfiltration) are filled and sealed in
sterilized cooled Ampoules under LAF (class-100) of Filling-Sealing machine.
The filled-Sealed Ampoules are then transferred to Moist Heat

Sterilizer for terminal sterilization at temperature 121 0C, 15
lb/cm2 for 30 minutes and then unload to cooling zone (25 0C).
Filled Ampoules checked by Inspection Machine.

After 14 days sterility test approved form microbiological section, Blister the filled sealed
Ampoules in Blister machine.
Then Final packing of Ampoule in unit cartons is done. After proper checking. SVPL release for
distribution.
PROCEDURE
The required quantity of Bottles are received. Then De-Cartoned the Bottles
and Loaded on online washing machine. Automatic Transferring to washing
zone through conveyors.
Automatic washing of bottles with WFI prepared by multi-column distillation
plant coming from 24 hours circulating loop system at 80C.
Drying of bottles at pre hot zone. Sterilization & De-Pyrogenation
(Endotoxin freeing) of dried vials at 310C. Rapid Cooling of bottles at 25C
at cooling zone. Transferring the washed sorted bottles in sterilized trays /
boxes. Rubber stopper, Flip off seal are sterilized under UV sterilizer-LAF
The night.
raw materials are dispensed according to raw material
over
requisition sheet.
Transfer required quantity of WFI from loop to the steam-jacketed covered washed and
sterilized processing vessel fitted with stirrer, in and outline nitrogen passing line and transfer
device. Add all weighed ingredients as per formulation sheet and order of mixing. Then
sampled by quality control for test release for filling.
Then transfer the solution from processing vessel to filling vessel through a
pump fitted with two stage cartridge filter (0.4 micron & 0.22 micron).
The sterilized LVPL solution (by microfiltration) are filled and sealed (by
Rubber stopper and flip of seal) in sterilized cooled bottle under LAF (class100) of Filling-Sealing machine.
The filled-Sealed Bottles are then transferred to Moist Heat

Sterilizer for terminal sterilization at temperature 121 0C, 15
lb/cm2 for 30 minutes and then unload to cooling zone (25 0C).
The QC released (Sterility test report) sterilized Filled bottles are
then labeled after visual inspection and packed in cartons with
prescribing information. Afetr final checking by QA, The final
products are release for distribution.
PHARMACEUTICAL FACTORY WITH EPOXY PAINTED PASSAGES

43
45
PHARMACEUTICAL PROCESS AREA
46
CLEAN ROOMS IN
PHARMA FACTORY
47
Man Flow
Material Flow
STERILITY TEST OF STERILE PRODUCT
OPHTHALMIC SOLUTION FILLING & SEALING MACHINE
LVPL Bottle Entry through De-Cartoning room to washing room
LVPL Bottle Washing Machine
LVPL Bottle Sterilizing Tunnel
Ampoule Washing Machine
Sterilizing Tunnel
BLISTERING OF TABLET &

CAPSULE WITH AUTOMATIC
BLISTER PACKING MACHINE
AUTOMATIC BLISTER & CARTONING MACHINE
59
TRAINING
OF reserved
PHARMACEUTICAL
WORK
FORCE
All rights
by the Presenter
Tuesday,
March
8, 2016
60
AN EXCLUSIVE TRAINING GIVEN BY MR. SALIM

JAHANGIR ON CGMP IN PHARMACEUTICAL
FACTORY
.
61
QUALITY CONTROL & QUALITY ASSURANCE

OF PHARMACEUTICAL PRODUCTS ARE
MANDATORY AS PER REGULATIONS
COMPLIANCE
DGDA ,DTL, DOE

USFDA 21 CFR PART 211
WHO c GMP
UK MHRA
TGA AUSTRALIA
ICH, PICs GUIDELINES
ISO 9001: 2008
ISO 14001
62
DGDA: Director General Drug Administration

DTL: Drug Testing Laboratory.
DOE: Department of Environment under Ministry of Environment &
Forestry , GOB.
USFDA 21 CFR PART 211 : United States Food & Drugs Administration 21
Code of Federal Regulations
WHO c GMP : World Health Organization - Current Good Manufacturing
Practice.
UK MHRA : United Kingdom Medicines and Healthcare Products
Regulatory Agency.
TGA AUSTRALIA : Therapeutic Goods Administration of Australia.
ICH Guidelines : International Conference on Harmonization Guidelines.
PICs Guidelines : Pharmaceutical Inspection Convention & Cooperation
Scheme. Guidelines
ISO 9001: 2008 - International Standardization Organization
ISO 14001-InternationalStandardization Organization 14001
(Environment)
63
Code of GMP Content
Introduction of GMP and cGMP

Premises
Personnel
Materials
Equipment
Training
Sanitation and hygiene
Documentation
Qualification and validation
Complaints & Product recalls
Validation
Self-inspection and quality audits
Good practices in production
Good practices in quality control
Contract production and analysis
Production, QC & Engineering Interfaces
Quality Management
Rules and Guidance

for Pharmaceutical
Manufacturers and
Distributors 2007
Compiled by the Inspection and Standards
Division of the
Medicines and Healthcare products
Regulatory Agency
London
65
CFR - Code of Federal Regulations Title 21

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 211 CURRENT GOOD

MANUFACTURING PRACTICE FOR
FINISHED PHARMACEUTICALS
[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2013]
[CITE: 21CFR211]
66
ISO 9001: 2008 CLAUSES

67
CONTINUAL IMPROVEMENT OF THE

QUALITY MANAGEMENT SYSTEM
C
U
S
T
O
M
E
R
R
e
q
u
i
r
e
m
e
n
t
s
Information Flow
Value Adding
Activities
S
a
t
i
s
f
a
c
t
i
o
n
Management
responsibility
Resource
management
INPUT
Measurement,
analysis,
improvement
PRODUCT
OUTPUT
INPUT
Product
realization
C
U
S
T
O
M
E
R
MODEL OF A PROCESS BASED QUALITY MANAGEMENT SYSTEM
69
70
BIOAVAILIBILITY & BIO-EQUIVALENCY TESTING OF DRUGS ON HUMAN & ANIMAL

AllSAMPLES
rights reserved
by the
Presenter IN Tuesday,
March 8, 2016
BLOOD
IS NEW
APROACH
BANGLADESH
71
All rights
reserved by the Presenter
Tuesday, March 8, 2016 AREA
ENVIRONMENT
MONITORING
OF MANUFACTURING
72
All rights reserved

by the Presenter
Tuesday,
8, 2016COUNTER
ENVIRONMENT MONITORING
OF MANUFACTURING
AREAMarch
PARTICLE
73
DOP TEST OF HEPA FILTERS
75
76
77
STERILITY TEST OF STERILE PRODUCT
Non-Viable Particle Count by Particle

Counter
Viable Particle Count
MICROBIAL COLONY COUNTER FOR COUNTING OF MICROBIAL COLONIES

GROWN ON MEDIA OF PETRIDISHES
ENDOTOXIN TEST OF STERILE PRODUCT BY LAL TEST METHOD
STERILITY TEST WITH MEMBRANE FILTRATION UNIT
Accelerated
Stability
Testing
of Products
All rights reserved
by the Presenter
Tuesday,
March 8, 2016
83
84
85
86
All rights reserved by theSPECTROPHOTOMETER

Presenter
ATOMIC ABSORPTION
87
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by the Presenter
Tuesday, March
8, 2016
MICRO WEIGHING
WITH
ELECTRONIC
BALANCE
88
All rights
reserved by
Presenter
Tuesday,
March
8, 2016
pH DETERMINATION
OF WATER
& the
OTHER
LIQUIDS
BY pH
METER
89
EFFECTIVE PEST CONTROL IS A REGULATORY & GMP

REQUIREMENT FOR PHARMACEUTICAL FACTORY
90
91
92
INSPECTION OF FINISHED SOLID PRODUCTS DISPENSING IN RETAIL

PHARMACY
DEAR PARTICIPANTS OF
SUB M-PHARM STUDENTS
Md. Salim Jahangir

Bachelor of Pharmacy (Hons)
Masters of Pharmacy (DU), MBA, ISO QMS
Lead Auditor
( Director Technical Operations,Head of Plant
& Quality Compliance)
For further information
Mobile: 01716560104
e-mail to : slm_jahangir@yahoo.com

Parenteral Products Manufacturing

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Tuesday, March 8, 2016

Presenter: Md Salim Jahangir, B-Pharm( Hons), M-Pharm(DU),

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY

RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY

FILLING & SEALING

FILLING & SEALING

RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY

TESTING (STERILITY &

RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY

RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY

All rights reserved by the

WASHING & DRESSING FACILITY AT EN FTRY IS

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

CLEAN DRESS IS THE PRIME COMPONENT OF PERSONNEL

Tuesday, March 8, 2016

CLEAN DRESS IS THE PRIME COMPONENT OF PERSONNEL

PERSONNEL ENTRY TO PRODUCTION AREA IS UNDER STRICT

PHARMACEUTICAL FACTORY CLEANING IS THE INTEGRAL

PRODUCTION CORRIDOOR OF PHARMACEUTICAL FACTORY

Tuesday, March 8, 2016

PHARMA CEUTICAL FACTORY MANUFACTURING AREA

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

All rights reserved by the Presenter

All rights reserved by the Presenter

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

All rights reserved by the Presenter

Tuesday, March 8, 2016

All rights reserved

PURIFIED WATER 24 HOURS CIRCULATING LOOP SYSTEM AT 85 0 C.

Tuesday, March 8, 2016

All rights reserved

RAW MATERIAL ARE PROCURED FROM WORLD RENOUNED

FLOW DIAGRAM OF STORAGE FACILITY & ISSUE SYSTEM

Issue of Raw Material against D.A

Release of Raw Material

Quarantine of Packing Material

Testing of Raw Material

Sampling of Packing Material

Finished (Final) Product

All rights reserved by the Presenter

Tuesday, March 8, 2016

FLOW DIAGRAM OF STORAGE FACILITY & ISSUE SYSTEM

Issue of Raw Material against D.A

Release of Raw Material

Quarantine of Packing Material