Best Varicose Veins Treatment in Jaipur

Dec 19, 20240 likes10 views

Varicose veins are enlarged veins near the skin’s surface, often found in the legs due to increased pressure from standing and walking. For Best Varicose Veins Treatment in Jaipur, Dr. Manish Rajput provides advanced, personalized care using modern techniques to help you achieve healthier, smoother legs and a better quality of life.

D R M A N I S H
RAJPUT
ht t ps://dr manishr ajput .com
Bookan appointment!

IN T R O D U C T IO N
Dr
. Manish Rajput is an I
nterventional
Radiologist & Team Lead, Team I
R
Jaipur
. They are the biggest team of
I
nterventional Radiologists. They are
trained from Tata Memorial Center
,
Mumbai, I
ndia. They have worked in so
many government and corporate
hospitals across the country.

Medical school (MBBS):2005-2011: -People’s
Medical College, Bhopal(MP)
DNB (Radio diagnosis):
- Apollo hospital,
Hyderabad(Telangana)
FVIR (PDCC):- Tata Memorial Centre,
Mumbai(Maharashtra)
Senior Resident: Hinduja Hospital Mumbai, SMS
Hospital Jaipur
Past Visiting Doctor:Leelavati Hospital Mumbai,
Breach Candy Hospital Mumbai, Wockhardt
Hospital Mumbai, Hinduja Hospital Mumbai
Ex Assitant Professor:JNU Medical College, Jaipur
Currently Working as Senior Consultant
Interventional Radiologist in various corporate
hospitals of Rajasthan based in Jaipur
HIS
EDUCATION

S T R E N G T H S
Ilead the biggest I
R team in the state.
Vast portfolio for I
R services.
All the team members are from Tata
Memorial Hospital, Mumbai.
Extensive experience in performing and
interpreting basic Radio-Diagnosis.
Gained experience in performing
I
nterventional Radiologic procedures.
Ipossess oratory skill by speaking at
numerous industry events.
Ability to teach complex concepts in a basic
manner
.

Varicose Veins Prostate Artery Embolization PRG
Biopsy and
fNAC
Angioplasty & Venoplasty PCN & DJ Stenting
O
U
R
S
E
R
V
I
C
E
S

+91 7729021111
dr.manish@infinityintervention.com
O-5-A, Adinath Marg, Near Surya
Hospital, C Scheme, Ashok Nagar,
Jaipur, Rajasthan 302001
C ON TA C T
US!

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PREMATURE RUPTURE OF MEMBRANES.pptx FOR NURSING STUDENTS CREATED BY KIRAN KAR... by KIRAN KARETHA, has 34 slides with 35 views.Premature rupture of membranes (PROM), also known as pre-labor rupture of membranes, refers to the rupture of the amniotic sac (or "water breaking") before the onset of true labor. TYPES Preterm premature rupture of membrane: when rupture of membranes occurs before the 37th week of gestational age. Term premature rupture of membrane: when rupture of membranes occurs at or after the 37th week of pregnancy but before the onset of true labor. 3) Prolonged premature rupture of membrane: when rupture of membranes occurs for more than 24 hours before delivery. 4) Pre-viable pre-term premature rupture of membrane: when rupture of membranes occurs before 24 weeks of gestation. It is also known as Mid-trimester premature rupture of membrane CLINICAL MANIFESTATION painless leakage of fluid from vagina fetal can easily feel through belly due to loss of fluid decrease uterine size abdominal pain and back pain fetal heart sound altered gush of fluid oligohydramnios DIAGNOSTIC EVALUATION History collection (steady loss of small amount of fluid from vagina) Sterile speculum examination: A sterile speculum examination involves using a sterile speculum, a medical instrument, to gently open the vagina for a visual examination of the cervix and vaginal walls, ensuring the speculum is sterilized before use, to prevent infection. Pooling test: During a speculum examination, healthcare providers look for amniotic fluid accumulating in the posterior vaginal fornix (the area at the back of the vagina). This pooling of fluid suggests that the amniotic sac has ruptured, allowing fluid to leak into the vagina. Nitrazine test: The nitrazine test, using nitrazine paper (phenaphthazine), is a method to determine vaginal pH and detect potential amniotic fluid leakage, which can indicate a ruptured amniotic membrane, by observing a color change from yellow to blue. Fern test: The fern test involves collecting a vaginal fluid sample, allowing it to dry on a glass slide, and then examining the dried sample under a microscope. When amniotic fluid is present, the sodium chloride in it crystallizes, forming a characteristic fern-like pattern. MANAGEMENT If the patient is term > 37 weeks : Approximately 90% of patient will go into spontaneous labor within 24 hours. labor should be induced either at the time of presentation or the patient can be expected managed. Induction of labor reduces the time of delivery and the rates of chorioamnionitis and endometritis and admission to the neonatal intensive care unit. If the patient does not go into spontaneous labor on her own then labor induction should be performed with oxytocin. So, use oxytocin or prostaglandins as indicated Otherwise, perform cesarean delivery. COMPLICATIONS IF FETUS REMAIN IN UTERO Neonatal conditions Infection and sepsis Deformations Umbilical cord compression Pulmonary hypoplasia

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Premature rupture of membranes (PROM), also known as pre-labor rupture of membranes, refers to the rupture of the amniotic sac (or "water breaking") before the onset of true labor. TYPES Preterm premature rupture of membrane: when rupture of membranes occurs before the 37th week of gestational age. Term premature rupture of membrane: when rupture of membranes occurs at or after the 37th week of pregnancy but before the onset of true labor. 3) Prolonged premature rupture of membrane: when rupture of membranes occurs for more than 24 hours before delivery. 4) Pre-viable pre-term premature rupture of membrane: when rupture of membranes occurs before 24 weeks of gestation. It is also known as Mid-trimester premature rupture of membrane CLINICAL MANIFESTATION painless leakage of fluid from vagina fetal can easily feel through belly due to loss of fluid decrease uterine size abdominal pain and back pain fetal heart sound altered gush of fluid oligohydramnios DIAGNOSTIC EVALUATION History collection (steady loss of small amount of fluid from vagina) Sterile speculum examination: A sterile speculum examination involves using a sterile speculum, a medical instrument, to gently open the vagina for a visual examination of the cervix and vaginal walls, ensuring the speculum is sterilized before use, to prevent infection. Pooling test: During a speculum examination, healthcare providers look for amniotic fluid accumulating in the posterior vaginal fornix (the area at the back of the vagina). This pooling of fluid suggests that the amniotic sac has ruptured, allowing fluid to leak into the vagina. Nitrazine test: The nitrazine test, using nitrazine paper (phenaphthazine), is a method to determine vaginal pH and detect potential amniotic fluid leakage, which can indicate a ruptured amniotic membrane, by observing a color change from yellow to blue. Fern test: The fern test involves collecting a vaginal fluid sample, allowing it to dry on a glass slide, and then examining the dried sample under a microscope. When amniotic fluid is present, the sodium chloride in it crystallizes, forming a characteristic fern-like pattern. MANAGEMENT If the patient is term > 37 weeks : Approximately 90% of patient will go into spontaneous labor within 24 hours. labor should be induced either at the time of presentation or the patient can be expected managed. Induction of labor reduces the time of delivery and the rates of chorioamnionitis and endometritis and admission to the neonatal intensive care unit. If the patient does not go into spontaneous labor on her own then labor induction should be performed with oxytocin. So, use oxytocin or prostaglandins as indicated Otherwise, perform cesarean delivery. COMPLICATIONS IF FETUS REMAIN IN UTERO Neonatal conditions Infection and sepsis Deformations Umbilical cord compression Pulmonary hypoplasia

PRETERM LABOR.pptx FOR NURSING STUDENTS CREATED BY KIRAN KARETHA by KIRAN KARETHA, has 40 slides with 402 views.PREMATURE LABOUR/ PRETERM LABOUR DEFINITION:  Pre term labour is defined by WHO as onset of labour prior to the completion of 37 weeks of gestation in a pregnancy beyond 20 weeks of gestation. INCIDENCE:  Globally, approximately 1 in 10 babies are born preterm (before 37 completed weeks of gestation), with an estimated 13.4 million preterm births annually. This means the incidence of preterm birth is roughly 10-11% worldwide.  In India, about 12% of babies are born preterm, which is higher than neighboring countries. ETIOLOGY:  In about 50%, the cause of preterm labour is not known- IDIOPATHIC  Some of the high-risk factors are:  HISTORY: previous history of abortion or preterm delivery Recurrent UTI Smoking habits Low socio-economic & nutritional status Previous abortion history Malpresentation  COMPLICATIONS IN PRESENT PREGNANCY: it may be due to maternal, fetal and placental. SIGN AND SYMPTOMS:  Backache  Contractions every 10 minutes, are more often  Cramping in lower abdomen  Menstrual like cramps  Fluid leaking from vagina  Flu like symptoms  Increased pressure in pelvis  Increased vaginal bleeding  Regular uterine activity  Vaginal spotting DIAGNOSIS:  Regular uterine contractions with or without pain (at least one in every 10 minutes.)  Dilation (2 cm or more) & effacement (80%) of the cervix  Length of cervix (2.5 cm or more.)  Funneling of internal OS INVESTIGATIONS:  Blood test  Urine analysis, urine culture and sensitivity  Cervicovaginal swab: culture and fibronectin test  Serum electrolyte and glucose level  USG COMPLICATION:  Birth of a pre-term baby A pre-term baby usually has following problems: • Low birth weight • Birth asphyxia • Neonatal jaundice • Underdeveloped organs etc. PREVENTIVE MEASURES: However, it is not possible to prevent occurrence of preterm labour completely, though its prevalence can be reduced using various measures at following three levels- 1) Prevention at primary level 2) Prevention at secondary level 3) Prevention at tertiary level 1) Prevention at primary level  In this, actions are taken prior to the onset of any disease which reduce or remove the possibility for occurring a disease.  For preventing preterm labour, following measures are applied at primary level. • Encourage the pregnant, to visit antenatal clinic regularly. • To identify high risk factors at its incipient stage and to provide appropriate treatment accordingly. • To provide special care to the women who have history of previous spontaneous abortion or preterm labour. • Advice the pregnant women regarding: Not to smoke and use of alcohol To take well balanced diet Avoid hard work Iron folic acid supplementation Maintaining adequate personal and environmental hygiene To contact the doctor immediately if any abnormal symptoms arise 2) Prevention at secondary level  In this level, actions are taken at the incipient stage of the disease so that it can be diagnosed.

PRETERM LABOR.pptx FOR NURSING STUDENTS CREATED BY KIRAN KARETHAKIRAN KARETHA

40 slides•402 views

PREMATURE LABOUR/ PRETERM LABOUR DEFINITION:  Pre term labour is defined by WHO as onset of labour prior to the completion of 37 weeks of gestation in a pregnancy beyond 20 weeks of gestation. INCIDENCE:  Globally, approximately 1 in 10 babies are born preterm (before 37 completed weeks of gestation), with an estimated 13.4 million preterm births annually. This means the incidence of preterm birth is roughly 10-11% worldwide.  In India, about 12% of babies are born preterm, which is higher than neighboring countries. ETIOLOGY:  In about 50%, the cause of preterm labour is not known- IDIOPATHIC  Some of the high-risk factors are:  HISTORY: previous history of abortion or preterm delivery Recurrent UTI Smoking habits Low socio-economic & nutritional status Previous abortion history Malpresentation  COMPLICATIONS IN PRESENT PREGNANCY: it may be due to maternal, fetal and placental. SIGN AND SYMPTOMS:  Backache  Contractions every 10 minutes, are more often  Cramping in lower abdomen  Menstrual like cramps  Fluid leaking from vagina  Flu like symptoms  Increased pressure in pelvis  Increased vaginal bleeding  Regular uterine activity  Vaginal spotting DIAGNOSIS:  Regular uterine contractions with or without pain (at least one in every 10 minutes.)  Dilation (2 cm or more) & effacement (80%) of the cervix  Length of cervix (2.5 cm or more.)  Funneling of internal OS INVESTIGATIONS:  Blood test  Urine analysis, urine culture and sensitivity  Cervicovaginal swab: culture and fibronectin test  Serum electrolyte and glucose level  USG COMPLICATION:  Birth of a pre-term baby A pre-term baby usually has following problems: • Low birth weight • Birth asphyxia • Neonatal jaundice • Underdeveloped organs etc. PREVENTIVE MEASURES: However, it is not possible to prevent occurrence of preterm labour completely, though its prevalence can be reduced using various measures at following three levels- 1) Prevention at primary level 2) Prevention at secondary level 3) Prevention at tertiary level 1) Prevention at primary level  In this, actions are taken prior to the onset of any disease which reduce or remove the possibility for occurring a disease.  For preventing preterm labour, following measures are applied at primary level. • Encourage the pregnant, to visit antenatal clinic regularly. • To identify high risk factors at its incipient stage and to provide appropriate treatment accordingly. • To provide special care to the women who have history of previous spontaneous abortion or preterm labour. • Advice the pregnant women regarding: Not to smoke and use of alcohol To take well balanced diet Avoid hard work Iron folic acid supplementation Maintaining adequate personal and environmental hygiene To contact the doctor immediately if any abnormal symptoms arise 2) Prevention at secondary level  In this level, actions are taken at the incipient stage of the disease so that it can be diagnosed.

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A New Era in Treating Advanced Ovarian Cancer: Practical Tips for Maximizing ...PVI, PeerView Institute for Medical Education

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Chair, Kathleen N. Moore, MD, MS, David M. O'Malley, MD, and Bhavana Pothuri, MD, MS, discuss ovarian cancer in this CME/MOC/NCPD/AAPA/IPCE activity titled “A New Era in Treating Advanced Ovarian Cancer: Practical Tips for Maximizing the Use of PARP Inhibitors, Immunotherapy, and ADCs.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at https://bit.ly/48VGDQV. CME/MOC/NCPD/AAPA/IPCE credit will be available until April 14, 2026.

UNIT 5TH PHARMACEUTICS SEMI SOLID DOSAGE FORM PPTAnkitVishwakarma84

47 slides•314 views

ANAESTHESIA MACHINE.pptx.pdf different partsSneha103657

28 slides•57 views

An anesthesia machine is a medical device used to deliver anesthetic gases and oxygen to a patient undergoing surgery or other medical procedures. It ensures that the patient remains unconscious, pain-free, and properly ventilated. Main Components of an Anesthesia Machine: Gas Supply: Oxygen (O₂), nitrous oxide (N₂O), and medical air are commonly used. Can come from cylinders or a hospital’s central gas supply. Flow Meters: Control the flow rate of gases going to the patient. Measured in liters per minute (L/min). Vaporizers: Convert liquid anesthetic agents (like isoflurane, sevoflurane) into gas form. Allows precise control of anesthetic concentration. Breathing Circuit: Connects the machine to the patient via a face mask or endotracheal tube. Includes inspiratory and expiratory pathways. Ventilator: Provides controlled or assisted breathing to the patient. Works in different modes like volume-controlled or pressure-controlled ventilation. Scavenging System: Removes excess anesthetic gases to prevent leakage into the operating room. Ensures safety for healthcare providers. Carbon Dioxide Absorber: Uses soda lime or another absorbent to remove CO₂ from exhaled air in a closed circuit. Safety Features: Alarms for oxygen failure, low pressure, or high airway pressure. Oxygen flush system for emergencies. Hypoxic guard to prevent delivery of pure nitrous oxide (ensuring oxygen is always mixed i

recent HIV/AIDS drugs and pharmacology by Dr Shraddha.pptxDr Shraddha Mishra

58 slides•33 views

Rasayan Therapy as per NCISM syllabus 25DrSakshi Bhardwaj

23 slides•75 views

PEPTIC ULCER DISEASE (PUD) , H PYLORI AND GERD TREATMENT BY DR .ANKUSH GOYAL ... by Dr Ankush goyal, has 43 slides with 37 views.Comprehensive Management of Peptic Ulcer Disease and GERD I. Introduction Peptic Ulcer Disease (PUD) and Gastroesophageal Reflux Disease (GERD) are distinct yet overlapping disorders of the gastrointestinal system, marked by significant morbidity worldwide. These conditions illustrate the consequence of a disturbed harmony between offensive gastric secretions and the protective barriers of the mucosa. From ancient remedies to modern-day proton pump inhibitors and eradication therapies, the treatment approaches to these disorders represent a triumph of translational medicine. While PUD typically involves mucosal erosion in the stomach or proximal duodenum due to Helicobacter pylori infection or NSAID use, GERD arises from the reflux of gastric contents into the esophagus due to incompetent lower esophageal sphincter tone. Both conditions necessitate a thorough understanding of their etiopathogenesis for rational therapy and long-term management. This document explores the latest, evidence-based treatment paradigms, structured with clarity and clinical relevance. --- II. Peptic Ulcer Disease (PUD) Definition and Epidemiology Peptic ulcers are breaks in the mucosal lining of the stomach or duodenum that penetrate the muscularis mucosa. Gastric ulcers typically occur on the lesser curvature of the stomach, while duodenal ulcers are found in the first part of the duodenum. Globally, the prevalence of PUD has declined, largely due to H. pylori eradication, yet NSAID-related ulcers persist, especially among the elderly. Etiology and Risk Factors Helicobacter pylori infection – Present in ~90% of duodenal and 70% of gastric ulcers. NSAIDs – Inhibit prostaglandin synthesis, compromising mucosal defense. Smoking – Impairs mucosal healing. Stress (critical illness) – Leads to stress ulcers. Zollinger-Ellison Syndrome – Gastrinoma with excess acid secretion. Corticosteroids, alcohol, and genetic predisposition are other contributors. Pathophysiology The balance between aggressive factors (acid, pepsin, H. pylori, NSAIDs) and defensive mechanisms (mucus, bicarbonate, blood flow, prostaglandins) determines mucosal integrity. H. pylori causes chronic inflammation and epithelial damage. NSAIDs decrease prostaglandins, reducing mucosal blood flow and bicarbonate production. --- III. Clinical Features of Peptic Ulcer Epigastric pain: Most common symptom; burning or gnawing in nature. Duodenal ulcers: Pain relieved by food, occurs 2–3 hours after meals. Gastric ulcers: Pain worsens with food intake. Nausea, bloating, early satiety Complications: Bleeding: Hematemesis, melena. Perforation: Sudden severe abdominal pain. Gastric outlet obstruction Penetration into adjacent organs (e.g., pancreas) --- IV. Diagnosis of Peptic Ulcer Endoscopy: Gold standard for diagnosis and biopsy to rule out malignancy. Rapid urease test, histology, urea breath test, stool antigen – for H. pylori. Serologic testing (less preferred). Barium study

PEPTIC ULCER DISEASE (PUD) , H PYLORI AND GERD TREATMENT BY DR .ANKUSH GOYAL ...Dr Ankush goyal

43 slides•37 views

Comprehensive Management of Peptic Ulcer Disease and GERD I. Introduction Peptic Ulcer Disease (PUD) and Gastroesophageal Reflux Disease (GERD) are distinct yet overlapping disorders of the gastrointestinal system, marked by significant morbidity worldwide. These conditions illustrate the consequence of a disturbed harmony between offensive gastric secretions and the protective barriers of the mucosa. From ancient remedies to modern-day proton pump inhibitors and eradication therapies, the treatment approaches to these disorders represent a triumph of translational medicine. While PUD typically involves mucosal erosion in the stomach or proximal duodenum due to Helicobacter pylori infection or NSAID use, GERD arises from the reflux of gastric contents into the esophagus due to incompetent lower esophageal sphincter tone. Both conditions necessitate a thorough understanding of their etiopathogenesis for rational therapy and long-term management. This document explores the latest, evidence-based treatment paradigms, structured with clarity and clinical relevance. --- II. Peptic Ulcer Disease (PUD) Definition and Epidemiology Peptic ulcers are breaks in the mucosal lining of the stomach or duodenum that penetrate the muscularis mucosa. Gastric ulcers typically occur on the lesser curvature of the stomach, while duodenal ulcers are found in the first part of the duodenum. Globally, the prevalence of PUD has declined, largely due to H. pylori eradication, yet NSAID-related ulcers persist, especially among the elderly. Etiology and Risk Factors Helicobacter pylori infection – Present in ~90% of duodenal and 70% of gastric ulcers. NSAIDs – Inhibit prostaglandin synthesis, compromising mucosal defense. Smoking – Impairs mucosal healing. Stress (critical illness) – Leads to stress ulcers. Zollinger-Ellison Syndrome – Gastrinoma with excess acid secretion. Corticosteroids, alcohol, and genetic predisposition are other contributors. Pathophysiology The balance between aggressive factors (acid, pepsin, H. pylori, NSAIDs) and defensive mechanisms (mucus, bicarbonate, blood flow, prostaglandins) determines mucosal integrity. H. pylori causes chronic inflammation and epithelial damage. NSAIDs decrease prostaglandins, reducing mucosal blood flow and bicarbonate production. --- III. Clinical Features of Peptic Ulcer Epigastric pain: Most common symptom; burning or gnawing in nature. Duodenal ulcers: Pain relieved by food, occurs 2–3 hours after meals. Gastric ulcers: Pain worsens with food intake. Nausea, bloating, early satiety Complications: Bleeding: Hematemesis, melena. Perforation: Sudden severe abdominal pain. Gastric outlet obstruction Penetration into adjacent organs (e.g., pancreas) --- IV. Diagnosis of Peptic Ulcer Endoscopy: Gold standard for diagnosis and biopsy to rule out malignancy. Rapid urease test, histology, urea breath test, stool antigen – for H. pylori. Serologic testing (less preferred). Barium study

Detailed Overview of the Drugs and Cosmetics Act, 1940 & RulesDr.Navaneethakrishnan S

23 slides•242 views

This presentation provides a comprehensive overview of the Drugs and Cosmetics Act, 1940, and its associated rules from 1945. It covers the objectives of the Act, its significance in regulating the import, manufacture, distribution, and sale of drugs and cosmetics in India. Key definitions such as drugs, cosmetics, misbranded, adulterated, and spurious products are explained in detail. Additionally, it highlights the legal definitions and important schedules to the Act, ensuring clarity on regulatory standards. Essential roles such as Drug Inspector and Government Analyst are also discussed. This presentation is useful for pharmacy students, regulatory professionals, and individuals interested in pharmaceutical law.

INFRARED THERAPY introduction slide.pptxanaidewah

33 slides•117 views

Liver - Surgical Anatomy, Abscess and Liver - TumoursUthamalingam Murali

59 slides•121 views

Good Automated Laboratory Practices (GALP) Standards, Compliance, and Impleme... by Dr. Smita Kumbhar, has 36 slides with 263 views.Good Automated Laboratory Practices (GALP) refers to a structured framework designed to ensure the reliability, accuracy, and integrity of data generated by automated laboratory systems. These practices encompass standard operating procedures (SOPs), regulatory compliance, software validation, and personnel training to maintain consistency in laboratory operations. GALP is essential for laboratories that rely on automation to process high volumes of data while ensuring regulatory adherence, particularly in pharmaceutical, biotechnology, and clinical research environments. Principles of GALP The fundamental principles of GALP include: 1. Data Integrity: Ensuring accurate, reliable, and tamper-proof data recording and analysis. 2. Regulatory Compliance: Adhering to national and international standards such as ISO, 21 CFR Part 11, and QCI guidelines. 3. Standardized Processes: Implementing well-defined SOPs to guide laboratory operations. 4. System Validation: Regularly verifying automated instruments and software for functionality and compliance. 5. Personnel Training: Ensuring that laboratory staff are adequately trained to operate automated systems efficiently and accurately. 6. Risk Management: Identifying and mitigating potential risks in automated workflows. 7. Continuous Improvement: Periodic reviews and updates to laboratory practices to incorporate technological advancements. GALP Requirements To implement GALP, laboratories must adhere to certain requirements: 1. Standardized Documentation: Maintaining comprehensive records of laboratory procedures and automation processes. 2. Software and Instrument Validation: Ensuring that all automated systems function as intended and comply with regulatory requirements. 3. Data Security Measures: Implementing encryption, access control, and audit trails for secure data management. 4. Regulatory Compliance: Aligning with relevant regulations such as 21 CFR Part 11, ISO standards, and QCI guidelines. 5. Personnel Competency: Conducting periodic training and assessments for laboratory staff. 6. Audit Readiness: Preparing for internal and external inspections by maintaining up-to-date documentation. SOPs of GALP Standard Operating Procedures (SOPs) form the backbone of GALP. These SOPs cover: 1. Instrument Calibration: Regular calibration and validation of automated instruments. 2. Data Entry and Management: Guidelines on recording, storing, and retrieving data in compliance with regulatory standards. 3. Sample Handling: Ensuring standardized procedures for sample collection, processing, and storage. 4. Software Usage and Maintenance: Guidelines on software validation, updates, and troubleshooting. 5. Audit Trail Management: Recording and reviewing all modifications made to electronic data. 6. Corrective and Preventive Actions (CAPA): Addressing non-compliance and implementing necessary improvements. Training Documentation A key aspect of GALP is personnel training, which includes: 1. Training Plans

Good Automated Laboratory Practices (GALP) Standards, Compliance, and Impleme...Dr. Smita Kumbhar

36 slides•263 views

Good Automated Laboratory Practices (GALP) refers to a structured framework designed to ensure the reliability, accuracy, and integrity of data generated by automated laboratory systems. These practices encompass standard operating procedures (SOPs), regulatory compliance, software validation, and personnel training to maintain consistency in laboratory operations. GALP is essential for laboratories that rely on automation to process high volumes of data while ensuring regulatory adherence, particularly in pharmaceutical, biotechnology, and clinical research environments. Principles of GALP The fundamental principles of GALP include: 1. Data Integrity: Ensuring accurate, reliable, and tamper-proof data recording and analysis. 2. Regulatory Compliance: Adhering to national and international standards such as ISO, 21 CFR Part 11, and QCI guidelines. 3. Standardized Processes: Implementing well-defined SOPs to guide laboratory operations. 4. System Validation: Regularly verifying automated instruments and software for functionality and compliance. 5. Personnel Training: Ensuring that laboratory staff are adequately trained to operate automated systems efficiently and accurately. 6. Risk Management: Identifying and mitigating potential risks in automated workflows. 7. Continuous Improvement: Periodic reviews and updates to laboratory practices to incorporate technological advancements. GALP Requirements To implement GALP, laboratories must adhere to certain requirements: 1. Standardized Documentation: Maintaining comprehensive records of laboratory procedures and automation processes. 2. Software and Instrument Validation: Ensuring that all automated systems function as intended and comply with regulatory requirements. 3. Data Security Measures: Implementing encryption, access control, and audit trails for secure data management. 4. Regulatory Compliance: Aligning with relevant regulations such as 21 CFR Part 11, ISO standards, and QCI guidelines. 5. Personnel Competency: Conducting periodic training and assessments for laboratory staff. 6. Audit Readiness: Preparing for internal and external inspections by maintaining up-to-date documentation. SOPs of GALP Standard Operating Procedures (SOPs) form the backbone of GALP. These SOPs cover: 1. Instrument Calibration: Regular calibration and validation of automated instruments. 2. Data Entry and Management: Guidelines on recording, storing, and retrieving data in compliance with regulatory standards. 3. Sample Handling: Ensuring standardized procedures for sample collection, processing, and storage. 4. Software Usage and Maintenance: Guidelines on software validation, updates, and troubleshooting. 5. Audit Trail Management: Recording and reviewing all modifications made to electronic data. 6. Corrective and Preventive Actions (CAPA): Addressing non-compliance and implementing necessary improvements. Training Documentation A key aspect of GALP is personnel training, which includes: 1. Training Plans

Ranitidine Recall:- Regulatory Response to NDMA ContaminationSuyash Jain

19 slides•117 views

Ranitidine Recall:- Regulatory Response to NDMA Contamination introduction about ranitidine rise and fall of ranitidine:- drug discovery pipeline NDMA Contamination: A Ticking Time Bomb VALISURA laboratory Claims by VALISURA Testing Methods for NDMA Regulatory Procedure Timeline European Medical Agency CHMP(Committee for Medicinal Products for Human Use) usfda Recall what are recalls 21CFR Recall Process: A Step-by-Step Guide Regulatory actions (FDA recall, EMA recommendations) Guidelines to consumers Alternatives to ranitidine What Ranitidine Taught Us About Drug Safety?