cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
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.
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
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
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.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
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.
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
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
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.
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Objective and policies of CGMP and Inventory control . This topic is from M.PHARM 1 st year syllabus from modern pharmaceutics
Objective and policies of CGMP
In vitro antidiabetic activity like
Inhibition of Polysaccharide-Degrading Enzymes
Assay for α-Amylase
Assay for α-Glucosidase
Everted Sac Technique for Assaying α-Glucosidase
Assays forGLUT2TransportActivity
Perfusion of Jejunal Loops
Transport Activity of Brush Border Membrane Vesicles
Apical Expression of GLUT2
Evaluation of Glucose Absorption InVivo
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.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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.
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
2. C-GMP
INTRODUCTION
C-GMP means Current good manufacturing practices.
What is CFR (Code of federal Regulations ), published by Federal government
In CFR total 50 Chapters
Chapter 3 : For US president
Chapter 50: For Fisheries & Wild life preservation
Chapter 21 : For Food & Drug manufacturing.
The US GMP regulations are divided into two parts: 210 and 211, Title 21.
• Part 210, “Current Good Manufacturing Practices in manufacturing, Processing.
Packing or Holding of Drugs “, basically it provides the framework for the
regulation.
• Part 211, “ Current good manufacturing practices for finished pharmaceuticals.
• The part 211 is further divided into 11 subparts ,Subpart A to Subpart K.
3. C-GMP
Content of part 211 of US GMP regulation:
• Subpart A : General Provision
• Subpart B : Organization and personnel
• Subpart C : Buildings and Facilities
• Subpart D: Equipments.
• Subpart E : Control of components and Drug product containers and
closures
• Subpart F : Production and process controls
• Subpart G: Packaging and labeling Control.
• Subpart H :Holdings and Distribution
• Subpart I: Laboratory Control .
• Subpart J: Records and reports
• Subpart K: Returned and salvaged drug products.
4. C-GMP
Principles of GMP
• To harmonize the manufacturing procedures globally with a marked
standard, which assures that the product is been manufactures in a good
facility and a quality product.
• It Provide the frame of SISPQ , i.e. Safety, Identity, Strength, quality, and
Potency to a drug product.
• GMP is based on the controlled production of the drug products, under
the federal Food , Drug and Cosmetic act, which states that , “ A drug
products will be deemed to be adulterated unless the method used in or
facilities or controls used for its manufacture, processing ,packaging, or
holding conforms to or are operates or administered in conformity with
current GMP.”
5. C-GMP
Role of GMP with respect to Quality
Management .
To provide the better control on the manufacturing practices
different QMS plan, i.e. Quality Management Systems. Are get
introduces, which are as follows:
• Preparation of a effective operating procedure, i.e. An
effective SOP for all the activities governing in the facilities.
• By taking proper Change control, Incidences, Deviations, with
proper investigation report.
6. Contd…
• By doing proper qualification of all the instruments and
equipments by performing all the qualification programs
:
• DQ (Design Qualification)
• IQ (Installation Qualification)
• OQ (Operational Qualification)
• PQ (Performance Qualification)
• FAT (Factory Acceptance Test)
• SAT(Site Acceptance test).
• By doing proper validation of all procedures and systems.
7. C-GMP
Role of GMP with respect to Personnel:
• Subpart B : Organization and personnel
• Every person involve in the manufacturing, process, packaging, or holding of
the drug products must have education, training and proper experience to
perform the activity in a proper and defined manner.
• Every employee should have a GMP training at least once in a year and also at
the time of induction only.
• Proper strength of qualified persons should be there.
• Proper Visit and Guidance of Consultant should be preferred.
• Personnel responsibilities :
1. Should wear clean clothing, also should take daily bath and shave.
2. Personnel shall practice good sanitization and health habits.
3. Access control should be there in controlled areas.
4. If you are ill or not healthy, plz take leave and come after complete fitness.
8. C-GMP
Subpart C- Building and facilities:
Design and construction features:
• Building should be of suitable size, construction location to facilitate cleaning,
maintenance, and proper operation.
• Space for all the equipments , instruments and also for storage of Raw
material , in process material and finished products.
• Movement of component should be controlled to avoid contamination.
Storage of release components, drug products containers, closures, and
labeling.
Holding of reject material and to be store them in lock and key.
Storage of in process material.
Manufacturing and processing operation.
Packaging and labeling.
Quarantine storage before release of drug products.
Storage of drug products after release.
9. C-GMP
Aseptic processing:
Floor, walls, and ceilings of smooth and hard surface that is easily
cleanable like epoxy coating on floors.
By avoiding corners and edges inside facility by doing cooing of corners.
Temperature and humidity control by installing BMS (Bio maintenance
system) and by AHU (Air handling Units).
By using HEPA filters under positive pressure.
Adequate lighting should be provides in all areas.
Heating, ventilation, and air conditioning (HVAC).
Plumbing.
Sewage and Sanitization.
10. C-GMP
Subpart D: Equipment:
Equipment should be appropriate design, adequate size, and suitably located
to facilitate operation for its intended use and for cleaning ad maintenance.
Equipment should be constructed with such a material that does not
contaminate the material in touch and also should be inert in nature, should
be corrosion free. Mainly stainless steel of desired grade is prefer, like SS 306
and SS 324 L (Used mainly in parental preparation manufacturing).
Equipment should be designed in such a way that’s its cleaning should be
conducted easily , also proper sanitization schedule should be there for every
equipment and instrument.
Calibration Schedule should be there at proper interval and also preventive
maintenance.
For those equipment which are software controlled or computer controlled
there should be a routinely calibration, inspection or checking program, with
respect to the SOP should be governed.
Proper Installation and validation of equipment should be performed and
documented.
11. C-GMP
Subpart F : Production and process control
Written procedures and procedure deviations.
Preparation of master formula record.
To follow the SOP during all process.
Proper flow in of material by FIFO mechanism.
Dispensing
Shifting.
Sampling and testing of in-process material and drug products
Proper equipment identification
Control of microbial contamination.
Reprocessing.
12. C-GMP
Subpart G: Packaging and Labeling control
Material examination and usage criteria: Testing , issuance , handling,
sampling, examination and approval.
Proper Issuance control.
Execution of proper Batch packaging records
Tamper evident packaging requirement for OTC human drug products.
Proper Labeling.
Proper container and closure selection.
Drug product inspection.
Expiration dating.
13. C-GMP
Quality Control ( Subpart I: Laboratory Control)
Responsibilities of quality control unit:
The QC unit must be given responsibility and authority to approve or reject all
components, drug products containers, closures, process material , Packaging
material, labeling and drug products. And the authority to review production
records.
Adequate laboratory facilities for testing and approval or rejection of the
above listed materials must be available.
Establishment of scientifically sound and appropriate specification, standard
test procedures, sampling plans, test procedures design to assure the material
conforms to appropriate standards.
Testing and release for distribution.
Stability testing
Reserve samples.
Animals used in testing components.
14. C-GMP
Contract manufacturing
When ever any organization is been having extra production requirement
and there facility is not been having that much capacity of production then
at that time the concept of Contract manufacturing or Loan licensing is
been introduces.
Criteria for contract manufacturing:
• Facility audits.
• Inspection program
• Self inspection and quality audits.
• Product audits
• Method transfer and method verifications.etc.