PARACETAMOL
MANUFACTURING
PLANT LAYOUT
OUR TEAM
NUR SYAKIRAH NAJWA NUR JANNATUL SABILA IZZAH AINA
TJ22035 TJ22038 TJ22032
NUR ALYA AINA NUR IZZAIDAH
TJ22031 TJ22054
Table of Contents
Introduction
Product Description
GMP Violation And Mitigation
Plant Layout
Conclusion
Function Each Room
References
Process Flow
Material Flow
Personnel Flow
INTRODUCTION
PARACETAMOL
a brief overview of the meticulous journey
Paracetamol undertakes in its transformation
from raw materials to the familiar and trusted
tablets we commonly use. Our pharmaceutical
plant design, adhering to stringent Good
Manufacturing Practices (GMP), ensures the
precision and quality required for the production
of Paracetamol tablets.
alleviating mild to moderate pain
and reducing fever.
addresses common discomforts
like headaches and muscle aches.
PRODUCT
DESCRIPTION
CHEMICAL PROPERTIES EXPLANATION
Chemical Name: Paracetamol (Acetaminophen)
To store raw materials including excipients, active
Raw material warehouse pharmaceutical ingredients (APIs), and other items
needed to formulate tablets
Chemical Formula
C8H9NO2
Class Analgesic, Antipyretic
PHYSICAL PROPERTIES EXPLANATION
Appearance White,crystalline powder or solid
Melting Point Approximately 169 C (336 F)
Solubility Soluble in alcohol and slightly soluble in water
Odor Odorless
Molecular Weight 151.16g/mol
PROCESS
DESCRIPTION
2. Granulation Room:
Function:
The Granulation Room facilitates the
transformation of Paracetamol and
excipients into granules, a key step in
tablet manufacturing.
Processes:
1. Mixing and Blending:
• Paracetamol and excipients undergo
thorough mixing and blending to achieve a
uniform blend.
• Homogeneity is critical for consistent
Paracetamol tablet quality.
2. Granulation (Wet/Dry):
• Granulation methods are employed to
form granules suitable for compression.
• Drying ensures optimal moisture content
for Paracetamol granules.
EQUIPMENTS
HIGH SPEED ELECTRONIC
COUNTING MACHINE
TABLET COATING MACHINE
A counting machine for
designed to apply a thin, Paracetamol ensures
uniform coating onto our
accurate dosage, facilitates
product
batch packaging, supports
quality control, and
enhances production
efficiency.
AUTOMATIC ROTARY
TABLET PRESS
compressing Paracetamol
granules into tablet form.
PLANT LAYOUT
FUNCTION OF EACH ROOM
ROOM FUNCTION
Receiving area Receive the new stock of raw materials
To store raw materials including excipients, active pharmaceutical ingredients (APIs),
Raw material warehouse
and other items needed to formulate tablets
The purpose of material staging spaces is to arrange equipment, components, and raw
materials needed for the production process in an orderly and methodical manner.
Material staging
This area makes sure that everything required to enable a seamless and effective
production workflow is conveniently accessible and readily available.
Samples from different phases of the production process are collected in the sampling
Sampling area area. This covers sampling of finished products, in-process samples, and raw
materials.
Air locks serve as transitional spaces designed to control the flow of personnel and
materials between areas with different cleanliness or environmental requirements.
Air locks
The primary function is to prevent the entry of contaminants, such as dust or
microorganisms, into controlled environments, especially cleanrooms.
Providing spaces for employees to take breaks, store personal belongings, and change
Changing area
into work attire.
FUNCTION OF EACH ROOM
ROOM FUNCTION
Real-time quality control inspections are carried out in the IPQC room at
different phases of the tablet production process. By ensuring that
IPQC
quality standards are fulfilled at every stage of manufacturing, it
facilitates the early detection and resolution of problems.
Completed tablet products, in-process samples, and raw materials can all
be thoroughly tested and analyzed in the Analysis Lab. It has the tools
Analysis lab
and analytical equipment needed to carry out a variety of tests,
including as impurity analysis, dissolution testing, and assays.
The waste Area is set aside for the appropriate gathering, sorting, and
Waste area
discarding of trash produced throughout the production process.
Housing utilities required for the manufacturing process, including
Utility room water purification systems, HVAC (Heating, Ventilation, and Air
Conditioning), and other support systems.
The canteen provides a meal and leisure space for staff members. It
Canteen offers a place for employees to eat, mingle, and take breaks throughout
the workday.
FUNCTION OF EACH ROOM
ROOM FUNCTION
The office serves as the hub for handling and carrying out
a range of administrative tasks. This covers duties
Office including organizing, coordinating, communicating, and
making decisions on how the tablet manufacturing
factory will run as a whole.
To pack finished tablets into their final forms, such as
Labelling and packaging room
blister packs or [Link] label the packaged.
Storage of finished pharmaceutical products in a
controlled environment. This room serves as a secure and
Finished product warehouse organized space for storing the manufactured tablets
before they are shipped to distribution centers or directly
to customers.
The tablets that have been packaged and labeled are
collected in the shipping area, verified for accuracy, and
Shipping area
then put onto vehicles to be delivered to retailers,
wholesalers, or other distribution locations.
PROCESS FLOW
Receiving Raw Material
Dispensing
Granulation
Tablet Compression
Coating
Packaging
Recieving area
MATERIAL FLOW Raw Materials
warehouse
Dispensing raw materials
Granulation
Tablet compressing
Coating
Packaging
PERSONNEL FLOW Changing area
Receiving raw material
Dispensing
Granulation
Compression
Coating
IPQC
personnel in
personnel out
PERSONNEL FLOW
IPQC
Analysis Lab
Packaging
Finished product warehouse
Shipping area
personnel in
personnel out
GMP VIOLATION AND ITS
MITIGATION
GMP VIOLATIONS MITIGATIONS REFERENCES
Production areas should be effectively ventilated, with air control facilities
(including temperature and, where necessary, humidity and filtration)
Production areas should have sufficient ventilation and air control systems that are
appropriate both to the products handled, to the operations undertaken within
suitable for the items being handled, the activities being performed there, and the
Inefficient Production Areas them and to the external environment.
surrounding environment. These systems should include temperature, humidity, and
PIC/S: PE 009-17 (PART 1)
filtration, as needed.
CHAPTER 3_3.12
Self-contained production areas having separate processing equipment and
separate heating, ventilation and air-conditioning (HVAC) systems. It may also
Poor Ventilation and Airflow Install an effective HVAC (heating, ventilation, and air conditioning) system to reduce the
be desirable to isolate certain utilities from those used in other areas;
Control chance of airborne contamination and maintain the proper level of air quality.
PIC/S: PE 009-17 (PART 1)
CHAPTER 5_5.21(ii)
vii. Design of cleaning processes for premises and equipment such that the
Poorly Designed Cleaning Develop and set up efficient cleaning practices and infrastructure to stop cross- cleaning processes in themselves do not present a cross-contamination risk;
Facilities contamination between various items. PIC/S: PE 009-17 (PART 1)
CHAPTER 5_5.21(vii)
All handling of materials and products, such as receipt and quarantine,
sampling, storage, labelling, dispensing, processing, packaging and distribution
As a way to prevent contamination and uncertainty during construction and operation, should be done in accordance with written procedures or instructions and,
Improper Material Handling
implement suitable materials flow systems. where necessary, recorded.
PIC/S: PE 009-17 (PART 1)
CHAPTER 5_5.2
Records should be made or completed at the time each action is taken and in
such a way that all significant activities concerning the manufacture of
Keep detailed records to monitor adherence to GMP regulations throughout the
Inadequate Documentation medicinal products are traceable.
construction.
PIC/S: PE 009-17 (PART 1)
CHAPTER 4_4.8
GMP VIOLATION AND ITS MITIGATION
GMP VIOLATIONS MITIGATIONS REFERENCES
The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed
Ensure that all utilities, including water and electricity, meet gases, etc;
Non-compliant Utilities
GMP requirements during construction and operation. PIC/S: PE 009-17 (PART 1)
CHAPTER 1_1.10(xi)
The manufacturer should provide training for all the personnel whose duties take them into
production and storage areas or into control laboratories (including the technical,
Provide training to construction personnel on GMP
Insufficient training for personnel maintenance and cleaning personnel), and for other personnel whose activities could affect
requirements to ensure awareness and adherence during
regarding GMP requirements the quality of the product.
the construction process.
PIC/S: PE 009-17 (PART 1)
CHAPTER 1_1.10(xi)
The monitoring and control of the manufacturing environment;
Failure to Monitor and Control Establish systems in production areas to track and manage
PIC/S: PE 009-17 (PART 1)
Environmental Conditions humidity, temperature, and other environmental factors.
CHAPTER 2_2.9(ii)
Specific measures for waste handling, contaminated rinsing water and soiled gowning;
Design appropriate waste disposal methods in order to
Improper Waste Management PIC/S: PE 009-17 (PART 1)
maintain environmental compliance and prevent
Practices CHAPTER 5_5.21(v)
contamination
Storage areas should be designed or adapted to ensure good storage conditions. In
particular, they should be clean and dry and maintained within acceptable temperature
Poorly Designed Storage Areas for Raw Provide suitable storage conditions, such as material limits. Where special storage conditions are required (e.g. temperature, humidity) these
Materials and Finished Products segregation and humidity and temperature management. should be provided, checked and monitored.
PIC/S: PE 009-17 (PART 1)
CHAPTER 3_3.19
CONCLUSION
The GMP Layout is designed to minimize cross-contamination while maintaining the
effectiveness of manufacturing pharmaceutical products.
The manufacturing process room includes dispensing, granulation, compression and
coating.
The GMP violations should be taken seriously as they can violate the
manufacturing process.
Therefore, steps of mitigation were taken to avoid this problem by following the
GMP requirements.
-REFERENCES-
1. baustill@[Link]. (2022, February 28). How Tablets Are Manufactured | Thomas Processing.
Thomas Engineering. [Link]
2. Manufacturing of Tablets by Direct Compression Method : Pharmaceutical Guidelines.
[Link]. [Link]
[Link]?m=1
THANK YOU
