This presentation is compiled by “ Drug Regulations” from freely available resources like the FDA on the World wide web.
“Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
This presentation is compiled by “ Drug Regulations” from freely available resources like the FDA on the World wide web.
“Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Personal Hygiene for pharma industry-Dr. A. AmsavelDr. Amsavel A
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash – How and when
Training & Practice
by Dr. A. Amsavel
It is real Art and Talent to make an effective Standard Operating procedure and understanding of the difference between guideline and SOP.
SOP should tell itself
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Personal Hygiene for pharma industry-Dr. A. AmsavelDr. Amsavel A
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash – How and when
Training & Practice
by Dr. A. Amsavel
It is real Art and Talent to make an effective Standard Operating procedure and understanding of the difference between guideline and SOP.
SOP should tell itself
The liquid oral manufacturing plant is designed to be operated by one operator and one helper, saving on precious man-power costs. Sugar syrup and manufacturing vessels are provided with limpet coils for heating and cooling, designed for internal vacuum to facilitate transfer of sugar directly from stores to sugar syrup vessel.
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Current good manufacturing Practices
Equipment and their maintenance
Production Management
Conclusion
References
Schedule M- Drugs and cosmetic act 1940 and rules 1945Swarna kumari S
Good Manufacturing Practices under Schedule M were made mandatory conditions for manufacturing operations of pharmaceutical formulations.
Part 1 and 2. Rules 71, 74, 76 and 78 GMP relating to factory premises and materials. requirement of plant and equipment.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
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.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
2. What is an equipments..???
Equipment may be defined as a
physical entity which is used to
carry out a general or specific
activity in the plant.
3. Types of Equipments
Single piece
E.g- tablet compression m/c, a mixer,
HPLC, FTIR, weighing balance etc.
Integrated system
E.g- water demineralising plants, an air
handling system etc.
4. Management of Equipments in Pharmaceutical
Plants as per International GMP Literature
Location
Design
Construction
Size
Adaptation
Cleaning & cross-contamination
Preventive & Breakdown maintenance
6. Life cycle of an Equipment
Decision to purchase an Equipment
Purchase of the Equipment
Qualifying, installation validating the
Equipment
Using the Equipment (operation, cleaning and
maintenance)
Preventive maintenance and revalidation
Replacing the Equipment
7. Contd……
Why, how, level of technology, send to suppliers the factory acceptance test is done
Expected life, capacity prepared as at fabricators premises
equipment is received
SOPs are made qualification validation
SOP how to operate process like IQ,DQ PQ
For maintenance are
made
replaced by new better
advanced equipment
8. WHO Guidelines for Equipments
Equipments must be located, designed, adapted and
maintained to suit the operation to be carried out.
Equipments should be installed in such a way as to
minimize any risk of error or of contamination.
Production equipment should be designed , located, and
maintained to serve its intended purpose.
Production equipment should be designed, so that it can
be easily and thoroughly cleaned on schedule basis.
Production equipments should not present any hazard to
the products.
9. Equipment Identification
WHO Guidelines:
Fixed pipe work should be clearly labeled to indicate
the contents and, where acceptable, the direction of
flow.
All service piping and devices should be adequately
marked and special attention paid to the provision of
non-interchangeable connections or adaptors for
dangerous gases and liquids.
10. Equipment Cleaning & Maintenance
WHO Guidelines
The layout and design of the equipment must aim to
minimize the risk of errors and permit effective cleaning and
maintenance.
Washing and cleaning equipment should be chosen and used
so as not to be source of contamination.
Defective equipment should, if possible, be removed from
production and Q.C. or at least clearly labeled as defective.
11. Filters
As a part of GMP, filters should be considered from
the following points-
1) Types of filter and filtration process
2) Compatibility of filter media with processing
materials
3) Cleaning of reusable filters and their sanitation
4) Validation of filters
5) Disposal of filters
12. Weighing Balance
WHO Guidelines
Balances and other measuring equipment of an
appropriate range and precision should be available for
production and control operation and should be
calibrated on a scheduled basis.
13. Weighing balance should be made with
following details
1. Description of balance
2. Model no.
3. Manufacturer name
4. Weighing range
5. Least count
6. Frequency of calibration
7. Location of balance
14. Documents and formats to be maintained for every
equipment
Name and unique identification number of the
equipment
Equipment manufacturers, name and address.
Additional information on contact persons and their
mobile phone numbers may be useful
Equipments capacity in terms of holding and output
15. Contd….
Materials of construction of drug contact parts
Electric power requirement details
Utilities required to operate the equipment e.g.- water,
steam, compressed air etc
16. Indian Pharmaceuticals Ltd. Machine Breakdown
Card
Sr.
no.
Date Time
Type of
Breakd
own
Maintained work
performed Time
In
house/
Ext
sign
Part
name/part
No.
Replaced
required From To
Att.
By
Checke
d by
16
Name of machine:
Department:
17. Indian Pharmaceuticals Ltd. Machine History Card
Sr.No. Date Time Nature of problem
Modification
made/rectification made
Time Sign
From To Atte
Checked
by
17
18. Indian Pharmaceuticals Ltd. List of Equipment
Sr.
No.
Name of
equipment
Capacity
holding/output
Make
Date of
installation
Materials construction of contact
part made up of
18
19. Indian Pharmaceuticals Ltd. Die Punch Inspection
Report
Sr. No. Tip size Body diameter Head
Overall
length
Working
length
Cup
depth
Reading
1
Reading
2
Go No go
19
20. Indian Pharmaceuticals Ltd. Equipment/ Instrument
Services History Card
Sr. No.
Details of repairs
servicing/calibration
Service called
on
Equipment
attended on
Serviced
by
Remark
20
21. Indian Pharmaceuticals Ltd. Equipment
Details Card
Drive Details
-------------------------------------------------------------------------------------------
Gear Box
------------------------------------------------------------------------------------------
Vacuum Pump
-----------------------------------------------------------------------------------------
Air Compression
……………………………………………………………………………..
Vibrator
------------------------------------------------------------------------------------------------
Coupling
----------------------------------------------------------------------------------------------
Chain and Sprockets
------------------------------------------------------------------------------------------------
Pully and V Belt
-------------------------------------------------------------------------------------------------
Bearing Details
------------------------------------------------------------------------------------------------
Fasteners
------------------------------------------------------------------------------------------------------------
21
22. REFERENCES
1. Potdar A. M., “CURRENT GOOD MANUFACTURING
PRACTICES for Pharmaceuticals”, Equipment (Chapter 3),
PharmaMed Press, Hyderabad, 1st Edition, 2008, pp- 85-100
2. Sharma P. P., “How to Practice GLP”, Practice of GLP (Equipment)
Chapter 7, Vandana Publications Pvt. Ltd., Delhi, 2nd Edition, 2008,
pp- 245-261
3. Shah H.D., “QA MANUAL”, Equipment (Chapter 5), Business
Horizons, New Delhi, 1st Edition (2nd Reprint), 2007, pp- 68-89
4. Sharma P. P., “How to Practice GMPs”, Practice of GMPs
(Equipment) Chapter 3, Vandana Publications Pvt. Ltd., Delhi, 4th
Edition, 2004, pp- 187-193