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.
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
Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
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.
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
Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
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
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
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
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
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
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
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
Martin has been writing this novel for over a decade and is has pushed back the release date numerous times. The good news is that Martin is close to finishing the novel. In December 2022, he said that he has about 500 pages to go.
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A few more months isn’t bad compared to over a decade of waiting. What is going to frustrate readers is the release date of the final book in the series. Will it take even longer than this novel? Once fans finish reading The Winds of Winter , they will be craving the final book in the series and it will be years before it will be released.
The presentation is a detailed description of the factories act 1948, its objectives, coverage, applicability, duties etc are mentioned in detailed and explained way. The presentation also includes various views of different history establishments. The presentations are a helpful guide for both commerce and law students.
The presentation is a detailed description of the factories act 1948, its objectives, coverage, applicability, duties etc are mentioned in detailed and explained way. The presentation also includes various views of different history establishments. The presentations are a helpful guide for both commerce and law students.
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The Factories Act, 1948, regulates the hours of work and minimum wages. The Factories Act, 1948, mandates the payment of minimum wages to the workers by prescribing a fixed pay rate. An employer shall pay their employees at least the prescribed minimum wage rate.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
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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,
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Chapter 3 - Islamic Banking Products and Services.pptx
Hazards and Risk Management
1. Presented by,
Manikandan V,
2061050002,
M. Pharm (Pharmaceutical Quality Assurance),
Department of Pharmacy,
Annamalai University.
Submitted to
Dr. G. Sivakamasundari, M. Pharm., Ph. D.,
Assistant Professor,
Department of Pharmacy,
Annamalai University.
UNIT V
HAZARD AND RISK MANAGEMENT
Factory Act and Rules, Fundamentals of Accident
Prevention, Elements of Safety Programme and
Safety Management
2. FACTORY ACT AND RULES:
There has been rise of large scale factory/ industry in India in the
later half of nineteenth century. Major Moore, Inspector-in- Chief of the
Bombay Cotton Department, in his Report in 1872-73 first of all raised the
question for the provision of legislation to regulate the working condition
in factories; the first Factories act was enacted in 1881.
Since then the act has been amended on many occasions. The
Factories Act 1934 was passed replacing all the previous legislation in
regard to factories. This act was drafted in the light of the
recommendations of the Royal Commission on Labour. This Act has also
been amended suitably from time to time.
3. The experience of working of the Factories Act, 1934 had revealed a
number of defects and weakness which have hampered effective
administration of the Act, and the need for wholesale revision of the act to
extend its protective provisions to the large number of smaller industrial
establishments was felt.
Therefore, the Factories Act, 1948 consolidating and amending the law
relating to labour in factories, was passed by the Constituent Assembly on
August 28, 1948. The Act received the assent of Governor General of India
on 23 September 1948 and came into force on April 1, 1949.
4. Objective of Factories Act, 1948
The main objectives of the Indian Factories Act, 1948are to regulate the
working conditions in factories, to regulate health, safety welfare, and
annual leave and enact special provision in respect of young persons, women
and children who work in the factories.
Working Hours
According to the provision of working hours of adults, no adult worker
shall be required or allowed to work in a factory for more than 48 hours in a
week. There should be a weekly holiday.
5. Health
For protecting the health of workers, the Act lays down that every factory
shall be kept clean and all necessary precautions shall be taken in this regard.
The factories should have proper drainage system, adequate lighting,
ventilation, temperature etc.
Adequate arrangements for drinking water should be made. Sufficient
latrine and urinals should be provided at convenient places. These should be
easily accessible workers and must be kept cleaned.
Safety
In order to provide safety to the workers, the Act provides that the
machinery should be fenced, no young person shall work at any dangerous
machine, in confined spaces, there should be provision for manholes of
adequate size so that in case of emergency the workers can escape.
6. Welfare
For the welfare of the workers, the Act provides that in every factory adequate
and suitable facilities for washing should be provided and maintained for the
use of workers. Facilities for storing and drying clothing, facilities for sitting,
first-aid appliances, shelters, rest rooms and lunch rooms, craches, should be
there.
Penalties
The provisions of The Factories Act, 1948, or any rules made under the Act,
or any order given in writing under the Act is violated, it is treated as an
offence. The following penalties can be imposed;
Imprisonment for a term which may extend to one year;
Fine which may extend to one lakh rupees; or
Both fine and imprisonment.
7. Applicability of Factories Act, 1948
The Act is applicable to any factory whereon ten or more workers are
working, or were working on any day of the preceding twelve months, and in
any part of which a manufacturing process is being carried on with the aid of
power, or is ordinarily so carried on, or whereon twenty or more workers are
working, or were working on any day of the preceding twelve months, and in
any part of which a manufacturing process is being carried on without the
aid of power, or is ordinarily so carried on; but this does not include a mine,
or a mobile unit belonging to the armed forces of the union, a railway
running shed or a hotel, restaurant or eating place.
8. Importance of Factories Act, 1948
The Factories Act, 1948 is a beneficial legislation. The aim and object
of the Act is essentially to safeguard the interests of workers, stop their
exploitation and take care of their safety, hygiene and welfare at their places
of work. It casts various obligations, duties and responsibilities on the
occupier of a factory and also on the factory manager. Amendments to the
Act and court decisions have further extended the nature and scope of the
concept of occupier, especially vis-a-vis hazardous processes in factories.
9. Duties of Factory Manager (Rules)
The Duties of Factory Manager are mentioned in the following Sections
of Factory Act, 1948.
Right of Workers to be warned about imminent danger. (Section 41-H)
It shall be the duty of such occupier, agent, manager or the person in
charge of the factory or process to take immediate remedial action if he is
satisfied about the existence of such imminent danger in the factory where the
worker is engaged in any hazardous process and send a report forthwith of
the action taken to the nearest Inspector
10. Notice of periods of work for adults. (Section 61)
The manager of the factory shall display correctly and maintained in
every factory in accordance with the provisions of sub-section (2) of section
108, a notice of periods of work for adults, showing clearly for every day the
periods during which adult workers may be required to work, fix the periods
during which each relay of the group may be required to work, classify them
into groups according to the nature of their work indicating the number of
workers in each group, shall draw up a scheme of shifts where under the
periods during which any relay of the group may be required to work.
11. Register of Adult Workers. (Section 62)
The manager of every factory shall maintain a register of adult workers,
to be available to the Inspector at all times during working hours, or when
any work is being carried on in the factory.
In State of Maharashtra V. Sampat Lal Mensukh Bothra (1992),it was
held that the obligation to maintain registers is imposed on the manager
12. Annual Leave with Wage. (Section 79)
For the purpose of ensuring the continuity of work, the occupier or
manager of the factory, in agreement with the Works Committee of the factory
constituted under section 3 of the Industrial Disputes Act, 1947 (14 of 1947),
or a similar Committee constituted under any other Act or if there is no such
Works Committee or a similar Committee in the factory, in agreement with
the representatives of the workers therein chosen in the prescribed manner,
may lodge with the Chief Inspector a scheme in writing whereby the grant of
leave allowable under this section may be regulated.
13. Notice of Certain Dangerous Occurrences. (Section 88A)
Notice of certain dangerous occurrences. Where in a factory any
dangerous occurrence of such nature as may be prescribed occurs, whether
causing any bodily injury or disability or not, the manager of the factory
shall send notice thereof to such authorities, and in such form and within
such time, as may be prescribed.
Notice of Certain Disease. (Section 89)
Where any worker in a factory contracts any disease specified in 1[the
Third Schedule], the manager of the factory shall send notice thereof to such
authorities, and in such form and within such time, as may be prescribed.
14. Safety and Occupational Health Survey. (Section 91-A)
The occupier or manager of the factory or any other person who for the
time being purports to be in charge of the factory, undertake safety and
occupational health surveys, and such occupier or manager or other person
shall afford all facilities for such every, including facilities for the
examination and testing of plant and machinery and collection of samples
and other data relevant to the survey.
15. Notice of Certain Accidents. (Section 88)
Where in any factory an accident occurs which causes death, or which
causes any bodily injury by reason of which the person injured is prevented
from working for a period of forty-eight hours or more immediately
following the accident, or which is of such nature as may be prescribed in
this behalf, the manager of the factory shall send notice thereof to such
authorities, and in such form and within such time, as may be prescribed to
the Chief Inspector.
16. Penalties under factory act, 1948
Section 92. General penalty for offences:
Save as is otherwise expressly provided in this Act and subject to the
provisions of section 93, if in, or in respect of, any factory there is any
contravention of the provisions of this Act or of any rules made there under
or of any order in writing given there under, the occupier or manager of the
factory shall each be guilty of an offence and punishable with imprisonment
for a term which may extend to two years or with fine which may extend to
one lakh rupees or with both, and if the contravention is continued after
conviction, with as further fine which may extend to one thousand rupees for
each day on which the contravention is so continued.
17. FUNDAMENTALS OF ACCIDENT PREVENTION:
Definitions of following things;
Incident – An incident is an undesirable occurrence that could, but
usually does not, result in a loss.
Accident – An accident is an unplanned, unforeseen and undesirable
occurrence which interrupts a normal activity and which result in either
an injury, loss of life, damage to material, equipment or facility or any
combination of these.
Preventable Accident – An accident that occurred as a result of an act
or failureto act on the part of an employee or the management or both.
Unpreventable Accident – An accident which no act whatsoever on the
part of the employee could have prevented the injury or damages to
vehicle, equipment or property.
18. Unsafe Act – Any act on the part of a person which increased his or her
chances of having an accident.
Unsafe Condition – A condition within the working environment which
increases the worker’s chances of having an accident, or which may
cause impairment of health.
Hazard – Any arrangement, equipment, material, object, condition,
method or procedure capable of causing bodily harm or impairment of
health or both.
19. Basic Activities
Successful accident prevention requires a minimum of four
fundamental activities
A study of all working areas to detect and eliminate or control
physical hazardswhich contribute to accidents.
A study of all operating methods and practices.
Education, instruction, training and discipline to minimize
human factors whichcontribute to accidents.
Thorough investigations of accidents to determine contributing
circumstances.
20. Most Accidents are Preventable
Many persons, either through ignorance or misunderstanding,
unfortunately believe that accidents are the inevitable results of
unchangeable circumstances, fate or a matter of luck.
It must be emphasized that accidents do not happen without
cause, and the identification, isolation and control of these
“causes” are the underlying principles of all accident prevention
techniques.
No person in a supervisory position can be effective in his job of
accident prevention unless he/she fully believes that accidents can
be prevented and constantly strives to do so.
21. Typical Unsafe Acts
The majority of unsafe acts of persons may be assigned to one or
more of the followingclassifications:
Failure to follow instructions or a proper job procedure.
Cleaning, oiling, adjusting or repairing equipment that is moving,
electrically energized or pressurized.
Failure to use available personal protective equipment such as
gloves,goggles, hard hats.
Failure to wear safe personal attire.
Failure to secure or warn.
Improper use of equipment.
22. Improper use of hands or body parts.
Making safety devices inoperative.
Operating or working at unsafe speeds.
Taking unsafe position or posture.
Unsafe placing, mixing, combining.
Using tools or equipment known to be unsafe.
Clowning.
Horseplay.
23. Control of Accident Causes
There are four main methods utilized in the control of accident
causes. They are (1) engineering; (2) education and training; (3)
enforcement; (4) enthusiasm. These four methods sometimes referred to
as safety, area as outlined below.
Engineering
Environmental causes of accidents, or unsafe conditions, can be
eliminated through the application of engineering principles. When an
operation is mechanically and physically safe, it is unnecessary to be
as concerned about the uncertain behavior (unsafe acts) of people.
Machines are less apt to fail than men. It may be necessary to make
mechanical revisions or modifications to eliminate existing unsafe
conditions and, in some cases, to prevent unsafe acts.
24. Education and Training
Just as safety engineering is the most effective way of preventing
environmental accident causes (unsafe conditions), safety education is the
most effective tool in the prevention of human causes (unsafe acts).
Through adequate instruction, personnel gain useful knowledge and
develop safe attitudes.
Safety consciousness developed in personnel through education will be
supplemented and broadened by specific additional instructions in safe
working habits, practices and skills.
Training is a particularly important accident prevention control; it
gives each man a personal safety tool by development in him habits of safe
practice and operation.
25. Enforcement
Usually accidents can be prevented through adequate safety
engineering and education. However, there are some people who are a
hazard to themselves and others because of their failure to comply with
accepted safety standards. It is these persons for whom the strict
enforcement of safety practices is necessary, backed by prompt corrective
action.
No organized accident prevention effort can be successful without
effective enforcement because accidents are frequently the direct result of
violations of safety principles. This is particularly true of vehicle accidents,
many of which are caused by unsafe acts which constitute traffic law
violations.
26. Enthusiasm
Can be effective to a good degree in prevention of accidents. When we
say one is enthusiastic about preventing accidents to himself or his co-
workers, we mean that he/she does all within his endeavor as a human
being to prevent the creation of an unsafe condition; corrects or reports an
unsafe act or a hazard; uses the right tool for the job; uses the personal
protective equipment provided for his job and works safely unsupervised.
An enthusiastic motorist would give up his right of way to an irate
driver who insists on grabbing it. Enthusiasm about safety or accident
prevention could be an inborn attitude and perhaps has ancestral origin. It
is something that comes out of one’s free will and no coercion whatsoever.
27. ELEMENTS OF SAFETY MANAGEMENT SYSTEM
A safety management system combines all the different elements in your
workplace that need attention to ensure you provide a safe working
environment for everyone who enters it.
Safety management systems make health and safety an integral part of
your business’s core operations. By designing, developing and implementing
an effective safety management system, you will have methods for managing
reporting, responsibilities, planning and resourcing to create a safer
workplace.
28. Safety management systems have six elements:
A safety plan
Policies, procedures and processes.
Training and induction.
Monitoring.
Supervision.
Reporting.
29. Safety plan
A safety plan is a strategic action plan that forms part of the business
plan. It analyses the current and prospective risk for a company and
charts how the risks will be eradicated and controlled over a calendar
period (the safety plan must have a budget).
This plan will ensure that there is a governance structure within your
company that ensures every worker clearly understands their safety
obligations (and how to comply) and is accountable to carry out those
obligations.
30. Policies, procedures and processes
Policies, procedures and processes include all safety paper
infrastructures within your company. This paperwork will describe all safety
behavior, expectations, record-keeping, incident reporting, and incident
notification documentation.
Training and induction
Depending on the nature of your workplace (whether it is low-risk or
high-risk), everyone who enters your workplace should receive training and
induction on: The rules of your company; The rules of the site; and The rules
of the location they are visiting. The training content will depend on the level
of risk the person is exposed to.
31. Monitoring
Your obligations to monitor your workplace depend on circumstances
and need. Always consider the level of risk. The higher the risk, the more
frequent and detailed the monitoring needs to be. Other times when
monitoring will be necessary include:
To ensure that all risk has been covered by a new risk assessment that
has been carried out due to a change in process, e.g. the installation of
new workstations.
When an investigation takes place following an incident.
32. Supervision
The only way to ensure your workers are carrying out their safety
obligations is to have adequate supervision. The level of supervision required
in your workplace will increase if the level of safety control put in place to
reduce a risk is low, i.e. the less effective the control measure used, the higher
the level of supervision necessary.
Reporting
The governance structure of your company needs safety reporting at all
levels, not just at board level. Your workers need to know what safety looks
like – what’s going right and what’s going wrong. This can only occur when
they receive safety feedback from you, e.g. how many hazards identification,
the risk levels associated with those hazards and what control measures were
implemented.