Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
Production Planning and Control
Objective of PPC
There are three stages in PPC
Classification/Functions of PPC
Benefits of PPC
Limitations of PPC
Production Planning / Operations Planning
Factors determining Production Planning Procedures
Production Planning System
Production Control
Factors Determining PC procedures
Main Functions of Production Planning
& Control Department
Plant Planning & Facility Planning
The uploaded Power point presentation is of Industrial Pharmacy-II Unit-I (Topic - Pilot Plant Scale up Techniques). ppt is very useful for student of B.pharmacy
Introduction, Objective; Significance; General consideration; Pilot plant scale up technique for solid, liquid and semi solids; SUPAC Guidelies; Introduction to platform technology
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
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.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
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.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
1. M. Pharm Sem-I Presentations
Pharmaceutical Plant Layout
SUBMITTED TO
SAVITRIB AI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARDOF
MASTER OF PHARMACY
IN THE SUBJECT
Pharmaceutical Manufacturing Technology
IN THE FACULTYOF SCIENCE ANDTECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
AcademicYear: 2021-2022 1
Presented By-
Bairagi Akshata A.
Guided By-
Dr. Sapna Ahirrao
2. Contents
Introduction
Features of Good Pharmaceutical Plant Layout
General Requirements of Pharmaceutical Plant
Principles of Plant Layout
Types of Plant Layout
Factors Affecting Plant Layout
Special Provisions Of Plant Layout
Production Planning
Managing Risks
Production Control
Advantages
Conclusions
3. Introduction
3
Pharmaceutical plant layout describes the distribution of space
and the arrangement of equipment, furniture, and other
significant administration and necessary services within a factory
building to perform the various unit operations involved in the
production of dosage forms in an efficient manner and with the
least amount of handling in processing the product from the
receipt of raw material through the distribution of the finished
goods.
4. Features of Good Pharmaceutical Plant Layout
4
• The following traits a successful pharmaceutical plant layout
should have:
• Ample floor space should be available for machine installation
and use.
• For low-cost processing, the equipment should be properly
organized to allow for the least amount of material handling.
• Effective supervision, coordination, and control of the
production processes should be possible with a proper layout.
• When necessary, there should always be an opportunity for
change and correction.
5. General Requirements For Pharmaceutical
Plant
• Pharmaceutical facilities must be positioned, planned, built, and
maintained to accommodate the procedures to be performed.
• To reduce the possibility of mistakes and enable efficient cleaning,
they must be laid out and designed in a way that prevents cross-
contamination.
• Manufacturing facilities should be built in a way that makes it possible
to maintain hygienic conditions at all times.
• For cleaning, maintenance, disinfection, and sanitization, SOPs and
records should be kept.
• Plants should be kept in order Power supply lighting, temperature,
humidity, and HVAC are all important factors.
6. Principles of Plant Layout
Principle of
minimum
movement
Principle of flow
Principle of
space
Principle of
safety
Principle of
flexibility
Principle of
interdependence
Principle of
overall
integration
Principle of
minimum
investment
7. Types of Plant Layout
7
Three different plant layouts exist:
Process flow
Product design layout
In a fixed place
1. Process layout: Based on their operational features, similar
machines are grouped together to form a process layout, also
known as a functional layout or a batch production layout.
2. Product layout: In product layout, also known as straight-line
layout, equipment is arranged in a single line in accordance with
the order of production processes.
3. Fixed position layout: Products that are too huge, heavy, or fragile
to move to a site for completion are put together in this type of
facility layout.
9. Factors Affecting Plant Layout
the proposed company's location
monetary considerations (cost)
building a factory
Product type Production method
Production volume
Equipment and machine types
Machinery and equipment repairs and maintenance
Needs of employees and safety
conditions that affect plants
10. Special Provisions of Plant Layout
Premises should
be suitable for
the purpose of
drug
manufacturing &
should prevent
mixing ups of
materials
Building for the
factory should be
constructed so as
to permit the
production under
hygienic
conditions
They should be
confirm to the
conditions laid
down in the
Factories Act,
1948
11. Production Planning
Production planning is a process of converting a set of inputs
such as men, capital, information, and energy into finished
products.
Steps involved in production planning
Production
budget
Selection of
process
Selection of
materials,
methods and
machinery
Selection of
layout
Setup time &
route sheet
process
12. Production Planning Includes
Routing –
Routing is the
path and
optimum
sequence of
operations to be
performed on
the job
Loading –
It indicates
assignment of
work to men,
machines in
advance without
specifying when
the work is to be
done
Scheduling –
It may defined
as the process of
decision taking
to start the work
for production
13. Managing Risks
Process of risk management - Rather than taking a reactive strategy,
risk management is always proactive.
The major goal of this strategy is to reduce the incidence and its
detrimental effects on project time, cost, and quality.
Clifford Gray and Eric W. Larson have broken down the risk
management procedure into four steps:
1. identification of risks
2. risk evaluation
3. development of risk responses
4. Risk response management
14. Production Control
It consists of two parts, progress reporting and corrective action
It involves four stages :
Observation Analysis
Correctiv
e action
Post
operation
evaluation
15. Advantages of Good Pharmaceutical
Plant Layout
• Maximum utilization of the floor area available for
production activities.
• Decreased risk of cross-contamination leads to higher
product quality.
• Efficient planning for raw materials and completed
goods receipt, transportation, storage, and delivery.
• Low material handling costs.
• Increased output with a lower chance of human error.
16. Conclusions
• Considering that choosing medication is a long-term
commitment, planning the layout is important.
• Additionally, it is a constant process because there is always
room for development.
• It should be planned in such a way that the output, floor area,
and manufacturing process all have the best possible
relationships, making the plant's operation very efficient.
• Although the layout of pharmaceutical plants varies from plant
to plant, the fundamental ideas behind pharmaceutical plant
layouts are often the same.
17. References
Manohar A. Potdar, Pharmaceutical Facilities, Second
Edition, Pharma Med Press.
Sheetal V. Patil, Dr. Md. Rageeb, PV, A Text Book of
Pharmaceutical Manufacturing Technology, Vikas &
Company (Medical Publishers), Page No.11-13.
https://www.pharmapproach.com/pharmaceutical-plant-
layout
https://www.slideshare.net/anks2017/plant-layout-ppt