This document provides an overview of facility design considerations for advanced sterile product manufacturing. It discusses key areas like area planning based on product type, facility classification, environmental control zones, wall and floor treatments, change rooms, personnel flow, and utility locations. Proper facility design with controlled environments and aseptic practices is necessary to ensure sterility of pharmaceutical products like APIs, antibiotics, and biological products during manufacturing.
“Pharmaceutical Processing is the process of drug manufacturing and can be broken down into a range of unit operations such as blending, granulation, milling, coating, tablet pressing, filling and others.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
“Pharmaceutical Processing is the process of drug manufacturing and can be broken down into a range of unit operations such as blending, granulation, milling, coating, tablet pressing, filling and others.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
An introduction to advanced aseptic processing technology, Aseptic processing facility design, Innovations in aseptic processing technology, Sterile product manufacture using form fill seal technologies, Aseptic processing transfer systems, Qualification/validation of aseptic processing environments, systems and equipment.
An introduction Aseptic processing facility design, Innovations in aseptic processing technology, Sterile product manufacture using form fill seal technologies, Aseptic processing transfer systems, Qualification/validation of aseptic processing environments, systems and equipment.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
An introduction to advanced aseptic processing technology, Aseptic processing facility design, Innovations in aseptic processing technology, Sterile product manufacture using form fill seal technologies, Aseptic processing transfer systems, Qualification/validation of aseptic processing environments, systems and equipment.
An introduction Aseptic processing facility design, Innovations in aseptic processing technology, Sterile product manufacture using form fill seal technologies, Aseptic processing transfer systems, Qualification/validation of aseptic processing environments, systems and equipment.
This presentation contains general guidelines and basic requirements of manufacturing of sterile medicinal products. This presentation is useful for training to the people involved in manufacturing of sterile pharmaceuticals or medicines.
Advanced manufacturing is the use of innovative technology to improve products or processes It can be defined as “The rate of technology adaptation and the ability to use that technology to remain competitive and add value to the advanced manufacturing sectors” In advanced aseptic processes, direct contact of the open product with an operator wearing a conventional cleanroom garment is not allowed Isolators effectively provide a seal against the entry of external contaminants using air over-pressure.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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1. M. Pharm Sem-II Presentations
ADVANCED STERILE PRODUCT MANUFACTURING TECHNOLOGY
SUBMITTED TO
SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF
MASTER OF PHARMACY
Pharmaceutical Manufacturing Techniques
Quality Assurance Technique
IN THE FACULTY OF SCIENCE AND TECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
Academic Year-2021-2022 1
Presented By-
Priyanka sananse
(Roll no. 12)
Guided By-
Dr. S.P. Ahirrao
2. CONTENT
• Introduction
• Area planning and environmental control
• Wall and floor treatment
• Change room
• Personnel flow
• Utilities and utilities equipment location
• Engineering and maintenance
2
3. INTRODUCTION
Advanced manufacturing is the use of innovative technology to
improve products or processes,with the relevant technology
being described as “advanced”,“innovative”, or “cutting edge”.
Advanced manufacturing industries “increasingly integrate
new innovative technologies in both product and processes.”
The rate of technology adoption and the ability to use that
technology to remain competitive and add value to define the
advanced manufacturing sector.
3
4. Manufacturing Area Planning
During facility designed, process requirement specific for each
product requirement must be consider also number of product
to be manufacture will impact facility design or area planning.
Product type
Chemical bulk drug substance[API]
Derived from chemical reaction. So facilities producing sterile
API will be required to provide protection to product during
synthesis, isolation, bulk filing.
An adjuvant produced by precipitation is an example of sterile
API
4
5. Potent compounds:
classified as those chemical drug that and considered toxic to humans
when exposure limits are exceeded, may cause allergic reaction, birth
defects, or other condition.
• For this reason it is acceptable to permit production of potent compound
in multiproduct facilities, provided the suite is segregated from other
operation.
Antibiotics
Produced to treat bacterial or fungal infection.it must be separated from
other product as potential for cross contamination. In addition to b-lactam
[penicillin] and non penicillin based (cephalosporin)antibiotic are not
permitted to produced in same facility as there is evidence of intolerance
for one antibiotic not another.
5
6. Biological product
This include therapeutic proteins generated by fermentation or cell culture
and inactivated vaccines. The facility is to be designed in same way as API
production , except that terminal sterilization is often not feasible, due to
fragility of the product.
6
7. FACILITY TYPE
Single product, dedicated
This facility is designed to produce a single product at one time, through
the year without concern for cross contamination with a second. The
facility can be operated to produce multi products in a series of campaigns,
converting between product.
Multiproduct multisite
This facility is designed to produced multiple products simultaneously in
multiple products simultaneously in multiple sterile suites. sterile
operation in each suites are to be segrageted from one another to ensure
that cross contamination is prevented.
7
8. 8
Production Description
• Conventional aseptic technology (open)
In this the product is exposed to the room environment during operation .
for this reason aseptic operation are required to performed under ISO 5
condition by sufficiently gowned operators trained in aseptic techniques.
Sterility assurance levels for aseptic operation, including filing of vials or
syringe, can be maximized through the use of barriers such as restricted
access barrier system isolators.
• Restricted access barrier(open and closed)
A restricted access barrier system RABS can be utilized in many application
in a fill finish area. RABS provides an enclosed environment to reduced
contamination to product, container, closure, compared to the risk
associated with conventional clean room operation.
9. Terminally sterilized product:
Whenever possible, it is required to terminally sterilized filled unit of
product. Terminal sterilization is known as an overkill sterilization.
Sterilization can be steam, by heat, gas, or radiation.
Classification of spaces:
Classification designation for classified GMP spaces include ISO 5(A), ISO
7(B), ISO 8(C), and ISO 9(D),which are assigned to spaces on the basis of
specific operational characteristic, product type, and or technology used
9
10. • Grade A:- The local zone for high-risk operational
Example :- filling and making aseptic connections.(unidirectional airflow
workstation)
• Grade B:-In aseptic preparation filling(background of A)
• Grade C &D:-Clean area for carrying out less critical stages in the
manufacture of sterile product (i.e. aseptic connection with aseptic
connectors and operations in closed system)
10
11. Classification of clean areas
11
Air cleanliness Maximum number of airborne
particles(m3)
Count under non-operating conditions Count under operating condition
>=0.5 µm >=0.5µm >=0.5µm >=0.5µm
Grade A (ISO 5) 3,520 20 3,520 20
Grade B(ISO 7) 3,520 29 352,000 29,00
Grade C(ISO 8) 352,000 29,00 3,520,000 29,000
Grade D 3,520,000 29,000 Dependent on process Dependent on process
attributes attributes
12. Floor system are critical and primary support areas of aseptic manufacturing
Facilities can be divided into two categories :sheet systems (PVC , Rubber)and
resin –based multilayer system.
The appropriate selection of either system is dependent on the following
criteria
1. Substrate conditions (New or existing concrete slabs)
2. Expected frequency of traffic (material loads)
3. Expected loading traffic (heavy rolling loads such as tanks, carts, etc )
In controlled ,non classified CGMP areas floor system such as pigmented
concrete sealer, sheet vinyl and thinner resin based systems may considered
for cost and functional reasons.
12
FLOOR SYSTEM
13. • It is composed of site fabricated assemblies (concrete block or metal stud
/gypsum board wall with applied coating) pre manufactured assembles
(modular clean room partition system ) or a hybrid of the two.
Wall system also evaluation on the basis of
• Expected frequency of reconfiguration/ relocation
• Ease of modification (future installation/removal of panels, door,
windows,etc)
• Design and construction schedule
• Regulations set by building code authorities and recommendation by
insurance.
13
WALL SYSTEM:-
15. • ENVIRONMENTAL CONTROL ZONE :
Zone 1: Plant Exterior – The environment within which a plant is located is the
first environment control zone.
Zone 2: Warehousing – The second environmental control zone provides
minimal protection and product . this barrier may be only marginally effective
against insects , rodents and birds.
Zone 3: General production and administration area- the third zone of
environmental control is formed by the periphery of the general production
area.
Zone 4: Clean Area –Production area immediately proceeding or following a
controlled environment area in the production flow are often controlled as an
area intermediate between general production area and a controlled
environmental area.
15
ENVIRONMENTAL CONTROL
16. Zone 5: weighing, mixing , and transfer area- Those activities of “Weighing,
mixing, filling or transfer operation ” addressed by cGMP section
212.81which are not handled as zone 6 but which require a controlled
environment.
Zone 6 : Filling Area- District zone of the controlled environment area for an
aseptic filling process but may not be a district zone for non-aseptic filling
processes.
Zone 7: Filling Line- The walls of the filling area are the last physical barrier
to the ingress of contamination, but within the filling area a technique of
contamination control known as laminar flow may be considered as the last
barrier to contamination.
16
17. CHANGE ROOM:-
Personnel access to all controlled areas should be through change rooms.
change room concept may vary from single closet size room to expensive
multi room complexes.
Entrance to change room area is normally through vestibules whose door
are electrically interlocked so that both cannot be opened simultaneously,
thus maintaining the necessary air pressure differential to prevent the
entry of airborne contamination
Upon entry to change room wash sinks provided for scrubbing hands and
forearms special filtered air driers are available to minimize creation of
particulate contamination.
17
18. IN some facilities , a foamed type of alcohol is dispensed on hands which
then evaporates. This is used to eliminate need for tap water and sinks in
the gowning rooms, since this can be potential source of contamination.
After hands are dry, garments are taken from dispensers and donned
while moving across a dressing bench. As a final gowning step ,aseptic
gloves are put on and sanitized.
Separated de gowning rooms are provided where the clean room
garments can be discarded prior to leaving the controlled zone.
18
21. The movement of personnel should be planned during the design of
individual plant areas.
Each individual production area may have a smooth and efficient personnel
flow pattern, a discontinuous or crowded pattern may develop when several
individual production area plants are controlled.
Security concern about the personnel flow may include minimized access to
controlled substance and minimizing the personnel traffic in or near work
area where controlled substance are handled.
The flow of material and personnel through corridors are in efficient and
unsafe path for moving material, particularly if heavy forklifts are required.
21
PERSONNEL FLOW
22. Parenteral plants, like any other plant have visitors and the degree of access
to be granted must be determined.
A glassed mezzanine or balcony provides absolute solution yet may give an
excellent view of the process, but not adaptable for single floor layouts.
Discontinuous and crowded flow pattern can decrease production efficiency,
increase security problems, and increase the problem of maintaining a claean
environment.
22
23. UTILITIES AND UTILITY EQUIPMENT LOCATION
UTILITIES: Piping system in particular, must be initially often
periodically cleaned and serviced.
Exposed overhead piping is not acceptable from a cleanliness or
contamination standpoint since it collect dirt is difficult to clean amd may
leak. Buried or concealed pipe may require unacceptable demolition for
cleaning or repair.
Whenever possible, major utility distribution services should located
outside of clean area.
Distribution system be exposed and not buried with in walls or ceilings.
23
24. UTILITIES EQUIPEMENT LOCATION
Public utilities require space for metering in addition to meeting electrical
power system require for switchgear and transformer.
Water system usually require treatment to ensure consistent quality. Plant
generated utilities typically require steam boiler room air, compressors,
and distillation, the typical boiler room approach.
Although a central location minimized distribution problems and
minimizes service distribution distances.
Proper equipment maintenance is difficult in foul weather especially
winter, heavy equipment may damage the roof structure,particularly if
the equipment location may requires numerous penetration through the
roof which coupled with equipment vibration will invariably lead to
leakage.
24
25. ENGINEERING AND MAINTENANCE
From an engineering stand point , even a location outside the plant can
serve well if access to the production area by engineers for field work is
not too difficult often particularly in small or less complex plants ,
maintenance or other pant services function such as utilities or combined
with engineering , making an I plant location desirable.
Maintenance responsibilities cover all area of the plant and can generally
be grouped into two categories
1. Plant maintenance
2. Production maintenance
25
26. Production maintenance is a direct production support function and
include all the routine and recurring operation maintenance work.
production maintenance facilities are usually minimal.
Plant maintenance operation , in contrast are more diverse .they vary
from heavy maintenance on production equipment to cosmetic work on
the building exterior and often include plant sevice function such as
sanitation ,ground sweeping , or waste disposal.
Facilities required are extensive and mostly include provides for
equipment cleaning .disassembly major rebuilding of equipment and
painting and these operation can present a contamination risk to
pharmaceutical operation and must be isolated.
26
27. 27
• CONCLUSION:-
Aseptic processing with discipline and taking advantage of the numerous
technical developments that have occurred over the year results in sterile
products that can be administered with complete confidence.
The wider adaptation of advanced aseptic processing will result in further
evolutionary improvements in aseptic processing.
The industry is at the beginning of the era in which human-scale aseptic
processing will be completed replaced by separative technologies and process
automation.
Additionally improved in-process controls are likely to be implemented making
validation easier and easing the compliance burden.
28. 28
• REFERENCES :-
1.International conference for standardization (ICH) (2004), cleanroom and
associated controlled environment –part7:separative devices (clean air hoods,
gloveboxes, isolators and mini environments), ISO 14644-7.
2.Whyte, w, and Eaton T.(2004),Microbiological contamination models for use
in risk assessment during pharmaceutical production, Eur J parental pharm
sci,9(1).