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
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
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
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
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.
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
This presentation describes Schedule M of Drugs & Cosmetic Act. It consists of Good Manufacturing Practices (GMP) for the manufacturing of drugs. Detailed guidelines about factory premises, machinery, process, quality control, etc. have been given.
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
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
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2 Case Reports of Gastric Ultrasound
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
3. DEFINITION:
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug
Administration (FDA).
cGMP provide for systems that assure proper design, monitoring, and control of manufacturing processes and
facilities.
Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring
that manufacturers of medications adequately control manufacturing operations.
This includes establishing strong quality management systems, obtaining appropriate quality raw
materials, establishing robust operating procedures, detecting and investigating product quality deviations, and
maintaining reliable testing laboratories.
This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent
instances of contamination, mix-ups, deviations, failures, and errors.
This assures that drug products meet their quality standards.
Definition of GMP as per WHO: GMP is that part of quality assurance, which ensures that products are consistently
produced and controlled to the quality standards appropriate to their intended use and as required by the marketing
authorization.
Krupanidhi College of Pharmacy (Q.A)
4. TRAGEDIES PREECEDING CGMP REGULATIONS
1902 - Development of the Biologic Control Act
1906 - Development of the Pure Food and Drug Act
1938 - Federal Food, Drug and Cosmetic Act
1941 - Initiation of GMP
1944 - Development of Public Health Services Act
1962 - Kefauver-Harris Drug Amendments released (It introduced a requirement for drug manufacturers to provide proof of the
effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side
effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough"
medications)
1963 - Establishment of GMPs for Drugs
1975 - cGMP for Blood and Components Final Rule
1976 - Medical Device Amendments
1978 - cGMP for Drugs and Medical Devices
Krupanidhi College of Pharmacy (Q.A)
5. 1979 - GLPs Final Rule
1980 - Infant Formula Act is passed
Sulfathiazole tablets contaminated with phenobarbital
1941 - 300 people died/injured
FDA to enforce and revise manufacturing and quality control requirements
1941 - GMP is born
Thalidomide tragedy
Thousands of children born with birth defects due to adverse drug reactions of morning sickness pill taken by mothers
Strengthen FDA’s regulations regarding experimentation on humans and proposed new way how drugs are approved
and regulated
“Proof of efficacy” law
Krupanidhi College of Pharmacy (Q.A)
6. COMPONENTS OF cGMP
a) GMP is a part of Q.A
b) GMP’s main function is to produce quality products consistently.
c) GMP must meet legal requirements of country.
d) GMP must meet both production and Q.C. related issues.
e) WHO further comments that the main function of GMP is to avoid mix-ups and contamination risks.
Krupanidhi College of Pharmacy (Q.A)
7. cGMP COVERS
a) General considerations
b) Personnel
c) Premises
d) Equipment
e) Sanitation
f)
SOP’s
g) Raw Materials
h) Self Inspection And Audit
i)
Master Formula Records
j)
Batch Manufacturing Records
k) Warehousing Area
l)
Labels And Other Printed Materials
m) QA
Krupanidhi College of Pharmacy (Q.A)
8. GENERAL CONSIDERATIONS
a) Compliance with GMP
b) Consistent uniform batches
c) Location And surroundings
d) Water system
e) Disposal Of Waste
Krupanidhi College of Pharmacy (Q.A)
12. POINTS TO BE CONSIDERED.
1) Location
2) Design
3) Construction
Location
Geography, climate and economic factors
Neighbours
a) What do they do?
Premises must be located to minimize risks of cross-contamination,
e.g. not located next to a malting factory with high airborne levels of yeast
Pollution/effluent control (E.T.P: Effluent treatment Plant).
Krupanidhi College of Pharmacy (Q.A)
13. Design
a)
b)
c)
d)
e)
f)
g)
h)
Minimize risks of errors
Permit effective cleaning
Permit effective maintenance
Avoid cross-contamination, build-up of dirt and dust
Maximum protection against entry of insects, birds and animals
Separate facilities for other products such as some antibiotics, hormones, cytotoxic substances.
Maximum protection against entry of insects, birds and animals.
Finishing floors, walls, and Ceilings sshould be smooth, impervious, hard-wearing, easy to clean
Specific Areas
1) Production areas
2) Quality control areas
3) Weighing areas
4) Storage areas
5) Ancillary areas
Hygiene
Eating, Drinking, Smoking Should not be allowed in the Production area.
Krupanidhi College of Pharmacy (Q.A)
14. 1. Design and construction features:
Any building used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size,
construction and location to facilitate cleaning, maintenance.
The orderly placement of equipment and materials to prevent mix-ups between different components, drug product
containers, closures, labeling, in-process materials, or drug products, and to prevent contamination.
2. Lighting: Adequate lighting shall be provided in all areas
3. Ventilation, air filtration, air heating and cooling.
Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when
appropriate for the manufacture, processing, packing, or holding of a drug product.
Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air
supplies to production areas. there shall be adequate exhaust systems or other systems adequate to control contaminants.
4. Plumbing
Potable water shall be supplied under continuous positive pressure in a plumbing system. Potable water shall meet the
standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations
Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break to prevent
back siphonage.
5. Sewage and refuse
Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary
manner.
Krupanidhi College of Pharmacy (Q.A)
15. 6. Washing and toilet facilities.
Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service
towels, and clean toilet facilities easily accessible to working areas.
7. Sanitation.
Building shall be free of infestation by rodents, birds, insects, and other vermin. Trash and organic waste matter shall be held
and disposed of in a timely and sanitary manner.
There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning
and sanitizing agents.
8. Maintenance.
Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state
of repair.
Krupanidhi College of Pharmacy (Q.A)
16. Pfizer Facility, Grange Castle site in Clondalkin, Ireland.
Krupanidhi College of Pharmacy (Q.A)
18. Equipment shall be located, designed, constructed, adapted and maintained to suit the operation to be carried out.
Should be made of non reactive material, such as High grade of steel(316,302)
Equipment should bea) Calibrated.
b) Checked.
c) Labelled.
d) Sterilized.
e) Accompanied with SOP.
Krupanidhi College of Pharmacy (Q.A)
22. Written procedures for:
a) Gowning and de-gowning S.O.P.
b) hygiene, health
c) waste disposal
Implementation and training of the employees in basic sanitation and toilet habits.
Practices not permitted
a)eating, smoking
b) unhygienic practices
Krupanidhi College of Pharmacy (Q.A)
24. STANDARD OPERATING PROCEDURE
There shall be written Standard Operating Procedure for each operation
It includea)For Equipment.
b)For sampling.
c)For Testing.
d)For Process.
f)For Packaging.
Krupanidhi College of Pharmacy (Q.A)
25. RAW MATERIALS
An Inventory should be maintained for Raw materials to be used at any stage of manufacturing:
Records should be maintain as per Schedule U.
Should be purchased from approved sources.
Must be checked by QC department on receipt .
Should be labeled.
Krupanidhi College of Pharmacy (Q.A)
26. SELF AUDIT & INSPECTION
Regular independent inspection is necessary to evaluate the manufacturer’s compliance with GMP in all aspects of
manufacturing
Procedure for self inspection shall be documented indicating
a)Evaluation
b)Conclusion
c)Recommendations for Corrective action
There should be a BMR ( Batch Manufacturing Record) and MFR (Master Formula Record).
Krupanidhi College of Pharmacy (Q.A)
27. PACKAGING & LABELING CONTROL
1. Materials examination and usage criteria.
Records shall be maintained for each different labeling and packaging material indicating receipt, examination or testing,
and whether accepted or rejected.
Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be
stored separately with suitable identification.
Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of finishing
operations.
2. Labeling issuance.
Strict control shall be exercised over labeling issued for use in drug product labeling operations.
Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the
master or batch production records.
3. Packaging and labeling operations.
Prevention of mix-ups and cross-contamination by physical or spatial separation from operations on other drug products
Examination of packaging and labeling materials for suitability and correctness before packaging operations, and
documentation of such examination in the batch production record.
Krupanidhi College of Pharmacy (Q.A)
28. 4. Tamper-evident packaging requirements
An OTC drug product for retail sale, that is not packaged in a tamper-resistant package or that is not properly labeled under
this section is adulterated under section 501 of the act or misbranded under section 502 of the act, or both.
Package the product in a tamper-evident package, visible evidence to consumers that tampering has occurred.
5. Drug product inspection.
Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and
packages in the lot have the correct label.
A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for
correct labeling.
Results of these examinations shall be recorded in the batch production or control records.
6. Expiration dating.
To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall
bear an expiration date determined by appropriate stability testing.
If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the
reconstituted and un-reconstituted drug products.
Expiration dates shall appear on labeling in accordance with the requirements.
Krupanidhi College of Pharmacy (Q.A)
30. Warehousing area should be designed and adapted to ensure good storage conditions.
Should be clean, dry and maintained with acceptable temperature limits.
Should have appropriate house-keeping and rodents, pests and vermin control.
Separate sampling area for active raw material and excipients.
Every Material stored should be labeled properly.
Fire Prevention
Krupanidhi College of Pharmacy (Q.A)
31. GMP IS ACTUALLY GOOD COMMON SENSE
Quality Management
Quality Assurance
GMP
Production and Quality Control
Krupanidhi College of Pharmacy (Q.A)
32. QUALITY ASSURANCE
The main objective of the quality assurance is to ensure the products are of the quality required for their intended use
Functions Adequates are made for manufacturing, supply and the use of correct starting and packing material.
Adequate control on starting material, intermediate, and bulk products.
Process validation in accordance with established procedures.
Krupanidhi College of Pharmacy (Q.A)
33. CONCLUSION
GMP compliance is not an option.
Quality should be built into the product.
GMP's are very similar and are really Good Common Sense.
Good Practices cover all aspects of manufacturing activities prior to supply.
The role and involvement of senior management is crucial
Krupanidhi College of Pharmacy (Q.A)