This presentation discusses the layout and services of a pharmaceutical building. It covers areas like ancillary areas for employee facilities, warehousing for storage of materials and products, production areas designed for specific product types, and quality control areas with separate labs. It also discusses services like drainage, waste disposal, maintenance, and sanitation needed to meet regulatory standards. The goal is to facilitate manufacturing while preventing contamination and ensuring product quality.
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
Schedule T: (Schedule T describes the Good Manufacturing Practice for Ayurvedic, Siddha and Unani Medicines.)
The Good Manufacturing Practices (GMP) are prescribed as follows:
Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.
The manufacturing process is as has been prescribed to maintain the standards.
Adequate quality control measures are adopted.
The manufactured drug which is released for sale is of acceptable quality.
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
Schedule T: (Schedule T describes the Good Manufacturing Practice for Ayurvedic, Siddha and Unani Medicines.)
The Good Manufacturing Practices (GMP) are prescribed as follows:
Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.
The manufacturing process is as has been prescribed to maintain the standards.
Adequate quality control measures are adopted.
The manufactured drug which is released for sale is of acceptable quality.
Design and Construction of plant as per the GMP Guidelines.pdfMohiniTawade
GMP is that part of Quality assurance which ensures that the products are consistently
manufactured and controlled to the Quality standards appropriate to their intended use
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Design and Construction of plant as per the GMP Guidelines.pdfMohiniTawade
GMP is that part of Quality assurance which ensures that the products are consistently
manufactured and controlled to the Quality standards appropriate to their intended use
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
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.
Solid waste management & Types of Basic civil Engineering notes by DJ Sir.pptxDenish Jangid
Solid waste management & Types of Basic civil Engineering notes by DJ Sir
Types of SWM
Liquid wastes
Gaseous wastes
Solid wastes.
CLASSIFICATION OF SOLID WASTE:
Based on their sources of origin
Based on physical nature
SYSTEMS FOR SOLID WASTE MANAGEMENT:
METHODS FOR DISPOSAL OF THE SOLID WASTE:
OPEN DUMPS:
LANDFILLS:
Sanitary landfills
COMPOSTING
Different stages of composting
VERMICOMPOSTING:
Vermicomposting process:
Encapsulation:
Incineration
MANAGEMENT OF SOLID WASTE:
Refuse
Reuse
Recycle
Reduce
FACTORS AFFECTING SOLID WASTE MANAGEMENT:
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.
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.
50 ĐỀ LUYỆN THI IOE LỚP 9 - NĂM HỌC 2022-2023 (CÓ LINK HÌNH, FILE AUDIO VÀ ĐÁ...
PRESENTATION ON building layout.pptx
1. PRESENTATION
ON
LAYOUT OF
BUILDING AND
SERVICES
PRESENTED BY :-
AYUSH DUBEY
SIDDHARTH TIWARI
CHHATRAPATI SHAHU JI MAHARAJ UNIVERSITY,
KANPUR
SCHOOL OF PHARMACEUTICAL SCIENCES, CSJMU
UNDER THE GUIDENCE OF :-
DR. MEENAKSHI GUPTA
ASSOCIATE PROFESSOR
3. INTRODUCTION
• Any building used in the manufacture,
processing, packaging or holding of drug
product shall be of suitable size,
construction and location to facilitate
cleaning, maintenance, manufacturing and
proper operation.
• The factory building used for manufacturing
of drug product shall be situated as to avoid
the risk of contamination from external
environment.
• The premises/ building shall conform to all
conditions laid down in Factories act 1948
SCHOOL
OF
PHARMACEUTICAL
SCIENCES,
CSJMU
KANPUR
3
4. AREAS OF PREMISES
1.ANCILLARY AREAS
2.WAREHOUSING AREAS
3.PRODUCTION AREAS
4.QUALITY CONTROL AREAS
School of Pharmaceutical Sciences, CSJMU Kanpur
4
5. ANCILLARY AREAS
Ancillary areas includes :-
• Rest and Refreshment rooms.
• Toilets and Washrooms.
• Clothes storage areas.
• Changing rooms for employees.
NOTE –
1. Rest and Refreshment Rooms should be separate from other areas.
2. Facilities for Toilets should not communicate directly with production or storage areas.
School of Pharmaceutical Sciences, CSJMU Kanpur 5
6. WAREHOUSING AREAS
Storage areas should have sufficient capacity to allow storage of the various categories of
materials and products like :-
I. Raw materials
II. Packaging Materials
III. Intermediates
IV. Bulk and finished products
V. Products in quarantine
VI. Released, returned, rejected and recalled products
School of Pharmaceutical Sciences, CSJMU Kanpur 6
7. • Storage areas should be designed to meet the required environmental conditions like:
Temperature and Humidity and Records should be maintained.
• Separate sampling areas should be provided for active and raw materials.
• Sampling of liquid materials, solvents, flammable materials or toxic, poisons or potent
materials should be done in separate areas with taking all the necessary precautions.
• All returned, rejected and recalled materials must be stored in lock and key and
necessary precaution should be taken.
• Dispensing areas should be separate for active and raw materials.
School of Pharmaceutical Sciences, CSJMU Kanpur 7
8. PRODUCTION AREAS
• General category products should be manufactured in separate manufacturing
facilities.
• Highly potent, sensitive or live micro-organism etc. should be produced in separate
areas to avoid cross contamination.
• Depending on the volumes of materials, adequate space should be provided.
• Production areas should be effectively ventilated with suitable designed HVAC system
appropriate to products being handled
• Production areas should be regularly monitored during production and non-production
periods to ensure compliance with their design specifications.
• Premises for packaging of pharmaceuticals should be specifically designed and out so
as to avoid mix-up and cross contamination
School of Pharmaceutical Sciences, CSJMU Kanpur
8
9. QUALITY CONTROL AREAS
• Q.C. laboratories should be designed to provide facilities for :-
I. chemical analysis
II. Instrumental analysis
III. Microbiological and biological analysis etc.
IV. Storage for control samples, glassware's, chemicals, documents etc.
V. A separate room or area should be provided where highly sensitive instruments are placed to
avoid interferences.
• Q.C. laboratories should be separate from production areas.
• Areas where biological, microbiological, or radio isotope test methods are employed should be
separate from each other.
School of Pharmaceutical Sciences, CSJMU Kanpur 9
11. SERVICES
1. DRAINAGE SYSTEM
2. DISPOSAL OF WASTE
3. MAINTENANCE
4. SANITATION
School of Pharmaceutical Sciences, CSJMU Kanpur
11
12. DRAINAGE SYSTEM
• Potable water shall be supplied under continuous pressure in a plumbing system free of
defects that could not contribute contamination to any drug product.
• Water not meeting such standards of regulatory guidelines shall not be permitted in the
potable water system.
• Drains shall be of adequate size.
• Drainage should be connected directly to the sewer and it should be provided with an air
break or other mechanical devices to prevent back Spoilage.
• A detailed SOP should be there for cleaning and sanitation of drains and their records
should be maintained and reviewed periodically.
School of Pharmaceutical Sciences, CSJMU Kanpur
12
13. DISPOSAL OF WASTE
• Sewage, waste and biomedical waste in and from the building premises shall be disposed
of in a safe and sanitary manner.
• Additional precautions shall be taken for the storage and disposal of rejected drugs/
materials and all the Records shall be maintained for disposal of waste.
• 'Hazardous, harmful, toxic substances and inflammable materials shall be stored in
suitably designed and separate enclosed areas in conformity with Central and State
Legislation.
• Records of all disposed material must be kept and should be available for inspection or
audit when required.
School of Pharmaceutical Sciences, CSJMU Kanpur
13
14. MAINTENANCE
• Any building, premises used in the manufacture, processing, packing or storage of a drug
product shall be in a good state of repair.
• Facility maintenance includes maintenance of following things:-
I. Leakage from ceiling or other surfaces.
II. Leakages from pipe lines of waters, steam, gases etc.
III. Plumbing problems.
IV. Loose or broken tiles.
V. Improper closing of doors, windows.
VI. Improper electrical wiring.
VII. Improper electrical fittings/ fixtures.
School of Pharmaceutical Sciences, CSJMU Kanpur
14
15. SANITATION
• "Any building/premises used in the manufacture, processing, packing or holding o a drug
product shall be maintained in a clean and sanitary condition".
• All the premises shall be free of infestation by rodents, birds, insects, and other vermin'
(other than laboratory animals).
• There shall be written procedures for use of suitable Rodenticides, insecticides, fumigating
agents and cleaning and sanitizing agents.
• In order to maintain sanitation and cleaning we have to consider following points
I. Create and maintain safe working environment.
II. Remove dust and dirt which can affect product quality.
III. Minimize the risk of cross-contamination occurring between products.
IV. Lastly, reduce the levels of microbial contamination.
School of Pharmaceutical Sciences, CSJMU Kanpur
15