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
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
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
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
Hospital infection control programs can help healthcare organizations monitor and improve practices, identify risks and proactively establish policies to prevent the spread of infections
WHO to provide technical support to develop a methodology to
monitor or ensure the quality, efficacy and safety of traditional
medicine and its products.
To promote and improve the quality of herbal medicines and
also to reduce the proportion of adverse effect caused by the
poor quality of herbal medicines.
Infection Control Guidelines for Pharmacy [compatibility mode]drnahla
Infection Control Guidelines for Pharmacy
Infection Prevention in Pharmacy
Dr. NAHLA ABDEL KADERوMD, PhD.
INFECTION CONTROL CONSULTANT, MOH
INFECTION CONTROL CBAHI SURVEYOR
Infection Control Director, KKH.
In this slides you knowing about the current good manufacturing practices, there are playing crusial role in a pharmaceutical industry.
In which slides cover the cgmp objective and location of industry and follow guidelines
Current good manufacturing practice .pptxOsamaTauseef2
Current good manufacturing practice according to Leon Lachman
Helpful contains for al pharmacy students like diploma, degree and also masters of pharmacy students
So use the contains and build your knowledge.
Hospital infection control programs can help healthcare organizations monitor and improve practices, identify risks and proactively establish policies to prevent the spread of infections
WHO to provide technical support to develop a methodology to
monitor or ensure the quality, efficacy and safety of traditional
medicine and its products.
To promote and improve the quality of herbal medicines and
also to reduce the proportion of adverse effect caused by the
poor quality of herbal medicines.
Infection Control Guidelines for Pharmacy [compatibility mode]drnahla
Infection Control Guidelines for Pharmacy
Infection Prevention in Pharmacy
Dr. NAHLA ABDEL KADERوMD, PhD.
INFECTION CONTROL CONSULTANT, MOH
INFECTION CONTROL CBAHI SURVEYOR
Infection Control Director, KKH.
In this slides you knowing about the current good manufacturing practices, there are playing crusial role in a pharmaceutical industry.
In which slides cover the cgmp objective and location of industry and follow guidelines
Current good manufacturing practice .pptxOsamaTauseef2
Current good manufacturing practice according to Leon Lachman
Helpful contains for al pharmacy students like diploma, degree and also masters of pharmacy students
So use the contains and build your knowledge.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
3. An Over View
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash –How and when
Training & Practice
4. Hygiene meaning
Collins Dictionary:
Hygiene is the practice of keeping your self and your
surroundings clean, especially in order to prevent
illness or the spread of diseases
Cambridge Dictionary:
The degree to which people keep themselves or their
environment clean, especially to prevent disease
5. DEFINITION
Contamination:
The undesired introduction of impurities of a chemical or
microbiological nature, or of foreign matter, into or onto a raw
material, intermediate, or API during production, sampling,
packaging or repackaging, storage or transport.
Cross-Contamination:
Contamination of a material or product with another material or
product.
6. CONTAMINATION CONTROL
API as well as drug product manufacturing area, specifically
clean room has to be designed and maintained to prevent or
minimize the contamination from microorganisms,
particulates etc Objective is
To ensue the Patient safety (contamination = risk to the patients)
To ensure quality, purity, safety and efficacy of the product
To comply GMP and Regulatory Requirement
Minimize the product defective / failure
Quality of product should be built into design and systems during
manufacturing,
7. SOURCES & CONTROL OF CONTAMINATION
Source Possibility of contamination Reduce / Elimination of
contamination
Personnel Improper gowning, not washing
hands properly, Lack of cleanliness,
Working with illness, etc
Hygiene procedure, Gowning, hand
washing, use of PPEs, Training,
Practice,
Environ-
ment
Lack of design, control &
monitoring. Open and access to bird
and vermin
Facility , HVAC design, Clean room,
Air filtration, Cleaning, Operation
and Maintenance
Equipment Unsuitable equipment, Lack of
cleaning/not easy to clean
Cleaning, Maintenance
Material Improper control of material.
Receipt, storage and transfer, et
Restriction, de-dust/ de-
contamintion.
8. GOOD MANUFACTURING PRACTICE
Q7 Good Manufacturing Practice emphasis the requirements to
Prevent contamination and cross-contamination by practicing
Good personnel hygiene and sanitization.
It is mandatory and to ensure the compliance
To ensue Product quality and avoid rejection
To employee safety
To avoid recall and complaints
To avoid warning letter / import alert
To avoid loss of business
9. ICH Q7: 3.2. PERSONNEL HYGIENE
3.20 Personnel should practice good sanitation and health habits.
3.21 Personnel should wear clean clothing suitable for the
manufacturing activity with which they are involved and this clothing
should be changed when appropriate. Additional protective apparel, such
as head, face, hand, and arm coverings, should be worn when necessary, to
protect intermediates and APIs from contamination.
3.22 Personnel should avoid direct contact with intermediates or APIs.
3.23 Smoking, eating, drinking, chewing and the storage of food should be
restricted to certain designated areas separate from the manufacturing areas.
10. 3.24 Personnel suffering from an infectious disease or having open lesion
son the exposed surface of the body should not engage in activities that could result
in compromising the quality of APIs.
Any person shown at any time (either by medical examination or supervisory
observation) to have an apparent illness or open lesions should be excluded from
activities where the health condition could adversely affect the quality of the APIs
until the condition is corrected or qualified medical personnel determine that the
person's inclusion would not jeopardize the safety or quality of the APIs.
11. 21CFR§211.28 REQUIREMENT
Personnel responsibilities.
a) Personnel engaged in the manufacture, processing, packing, or holding
of a drug product shall wear clean clothing appropriate for the duties they
perform. Protective apparel, such as head, face, hand, and arm coverings,
shall be worn as necessary to protect drug products from contamination.
b) Personnel shall practice good sanitation and health habits.
c) Only personnel authorized by supervisory personnel shall enterthose
areas of the buildings and facilities designated as limited-access areas.
12. PERSONNEL RESPONSIBILITIES.
d)Any person shown at any time (either by medical examination or supervisory observation) to
have an apparent illness or open lesions that may adversely affect the safety or quality of
drug products shall be excluded from direct contact with components, drug product
containers, closures, in-process materials, and drug products until the condition is corrected
or determined by competent medical personnel not to jeopardize the safety or quality of drug
products.
All personnel shall be instructed to report to supervisory personnel any health conditionsthat
may have an adverse effect on drug products.
13. MANUFACTURING CONTROL
1.Written procedures are established and followed
- master formula, manufacturing record and packaging record
2. Critical Process are validated
QUALITY CONTROL DEPARTMENT
1. Testing of bulk components prior to use by production
2. Testing of finished product prior to release for sale
3. Stability Program
14. RECORDS
1. Document all GMP activities
2. Use Good Documentation Practice (GDP)
3. Records must be readily available
GOOD DOCUMENTATION PRACTICE
Documentation must be:
1. Permanent (Black or Blue Ink)
2. Clear, Legible
3. Accurate
4. Timely, Complete
15. STABILITY
1. Establish the length of time in which the product meets all
specification
2. Monitor the drug for this period of time
STERILE PRODUCTS
1. Packaged in separate enclosed area by trained personnel
using method to ensure sterility
16. STORAGE
1. No materials should be stored on floor.
2. All materials to be labeled (Name, Mfg. date, Exp. Date,
Batch no. etc ).
3. Continuous temperature monitoring device should be applied
to any critical storage area, like cold room.
17. 1. GMP in solid dosage forms
2. GMP in semisolid dosage forms
3. GMP in liquid orals
4. GMP in parenteral production
5. GMP in ayurvedic medicines
6. GMP in bio-technological products
7. GMP in nutraceuticals and cosmeceuticals
8. GMP in homeopathic medicines
GMP IN…….
18. Abbreviation Elaboration
SOP Standard Operating Procedures
STP Standard Testing Procedure
BMR Batch Manufacturing Record
API Active Pharmaceutical Ingredient
FIFO First In First Out
FEFO First Expire First Out
HVAC Heating, Ventilation and Air Conditioning
HEPA High Efficiency Particulate Air Filter
OOS Out of Specification
19. WHY GMP IS IMPORTANT
1. A poor quality medicine may contain toxic substances
that have been unintentionally added.
2. A medicine that contains little or none of the claimed
ingredient will not have the intended therapeutic
effect.