1. The document discusses pharmaceutical validation including calibration and validation master plans. It defines validation and calibration, outlines their objectives and importance.
2. It describes the scope and methods of validation including process, analytical, equipment and cleaning validation. It also discusses the merits of validation in ensuring consistency and reducing risks.
3. The document provides details on validation master plans including contents such as introduction, methodology, personnel, schedules, documentation etc. It also discusses calibration master plans, the need for periodic calibration of instruments and maintaining calibration records.
ICH and WHO Guideline for Validation and Calibration.pptxRAHUL PAL
Validation: Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.
Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard.
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
ICH and WHO Guideline for Validation and Calibration.pptxRAHUL PAL
Validation: Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.
Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard.
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
Introduction to Pharmaceutical Validation, Scope & Merits of Validation, Validation and calibration of Master plan, Hrs ICH & WHO guidelines for calibration and validation of
equipment's, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
Introduction to Pharmaceutical Validation, Scope & Merits of Validation, Validation and calibration of Master plan, Hrs ICH & WHO guidelines for calibration and validation of
equipment's, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Complete discussion about the Pharmaceutical validation, its types, difference between calibration and validation, validation master & calibration master plan
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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
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.
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
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
3. 3
INTRODUCTION
DEFINITION:
According to FDA:
“Establishing the documented evidence which provides a high degree of assurance that a specific process will
consistently produce a product of predetermined specifications and quality attributes”.
OR
“Process validation is defined as the collection and evaluation of data, from the process design stage to
commercial production, which establishes scientific evidence that process is capable of consistently delivering
quality product”.
4. 4
According to EU GMP:
“Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment,
material, activity or system actually leads to expected results”.
Validation should thus be considered in the following situations:
Totally new process
New equipment
Process and equipment which have been altered to suit changing priorities
Process where the end product test is poor and an unreliable indicator of product quality.
5. 5
OBJECTIVES
To reduces risk of regulatory non-compliance.
Reduction of time to the market for the new products.
Eliminates the scrap & reduces the defect cost.
To reduce chances of product re-call from market.
The final release of the product batch would be expedited.
It requires less in-process control & end process testing.
Parametric release of batch can be achieved in validation.
6. 6
SCOPE OF VALIDATION
Pharmaceutical Validation is a vast area of work and it practically covers every aspect of pharmaceutical processing activities,
hence defining the Scope of Validation becomes a really difficult task. However,
operations will point out at least the following areas for pharmaceutical validation.
Analytical
Facilities
Manufacturing operations
Product Design
Cleaning
Instrument Calibration
Process Utility services
Raw materials
Packaging materials
Equipment
a systematic look at the pharmaceutical
7. 7
MERITS OFVALIDATION
Knowledge of the process increases during the validation process.
Consistency of the process is ensured.
It decrease the risk of the manufacturing problems.
Ensures the fluency of the production.
Decrease the expenses.
Decrease the risk of failing in GMP.
8. UNITS OF VALIDATION PLANNING AND
ORGANIZATION
8
DEPARTMENT RESPONSIBILTY
R & D Executive officer To coordinate the entire validation process by scheduling
meetings and discussions with production, quality control and
quality assurance. Preparation of preliminary validation protocol,
master formula record.
Quality assurance Officer Preparation of validation protocol, monitoring the process,
compiling and analyzing data and test results and preparing the
final report. To review of validation documents
Production Officer To participate in performing the validation steps during
manufacturing processes. To assist in collection of data
Quality control Officer To test and report the test results
Quality assurance General manager To approve the process validation protocol
9. 9
METHODS OF VALIDATION CAN
PROCESS VALIDATION
ANALYTICAL VALIDATION
EQUIPMENT VALIDATION
QUALIFICATION
CLEANING VALIDATION
BE CLASSIFIED AS
10. 10
VALIDATION MASTER PLAN
A Validation Master Plan, also referred to as "VMP", outlines the principles involved in the qualification of a
facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining
a qualified facility. A VMP is the foundation for the validation program and should include process validation, facility
and utility qualification and validation, equipment qualification, cleaning and computer validation.
It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a
structured approach to validation projects.
Food and Drug Administration inspectors often look at VMPs during audits to see whether or not a facility's
validation strategy is well thought-out and organized. A VMP should have logical reasoning for including or
excluding every system associated with a validation project based on a risk assessment.
11. 11
MEMBERS OF VMP
Validation manager(quality assurance department)
Member from production
Members of engineering
Members from calibration lab
Members from QC lab
Members from maintenance
Members from HVAC department
Members from product development lab
12. 12
CONTENTS OF VMP
(FACTORS TO BE CONSIDERED)
Introduction
Methodology
Qualification
Personnel
Schedule
Preventative maintenance
Change control
Procedure
Documentation
Appendices
14. 14
INTRODUCTION
This section is written as an introduction to the validation process and
facility, and it is intended to set the scene
The introduction of a VMP should include following details:
a description of facility, its premises and equipment, and its purpose.
intension and scope of validation
other relevant site policies and plans, like factory or corporate policy
statements on GMP,QA etc.
15. 15
This section should address the predetermined requirements by identifying the
standards that are to be applied to the facility.
These are then used in the development of the acceptance criteria that are used to
judge the validation
It also involves planning and execution of documents such as, protocols, records,
reports, or other.
The standard will involve three elements:
Regulatory and guidance documents
National standards
Company standards
16. 16
PERSONNEL
The CFR 21 states “ Each person engaged in and each person responsible for
supervising the manufacture, processing, packaging or holding a drug product shall have
the education, training, and experience, or a combination thereof, to enable that person to
perform the assigned functions.”
The VMP should lay down the principles for personnel requirements.It must address
the aspects like; experience of personnel (written biographies or CV), in-house training
reports, etc,.
Documenting the training is essential and is a requisite of the GMPs.
17. 17
Schedule:
The work program is essential and should be prepared at an early stage.
A good plan will contain all the necessary features which are to be considered during
execution of a plan and determines the control of the project.
It ensures that all the personnel involved in the VMP are not only aware of the
engineering targets, but also the validation targets.
Preventative maintenance:
This is the responsibility of Site maintenance and Operation dept. This activity should
be performed during the design phase, and the documentation required should be, included
in the requisition.
18. 18
This section usually used to identify the documentation
produced for the processing like;
that should be
•Engineering drawing
•Equipment supplier drawing and
•Factory acceptance documents
•IQ documents
•OQ documents
•PQ documents
documents
Appendices:
The appendix is mostly used VMP to hold the information of type of
documents and formats that will be used in the execution stage
19. 19
CALIBRATION MASTER PLAN
“Automatic, mechanical, or electronic equipment or other types of equipment, including
computers, or related systems that will perform a function satisfactorily, maybe used in the
manufacture, processing, packing, and holding of a drug product. If such equipment is so
used, it shall be routinely calibrated, inspected, or checked according to a written program
designed to assure proper performance. Written records of those calibration checks and
inspections shall be maintained.”
-US Code of Federal Regulations, 21 CFR 211.68
20. 20
WHATIS CALIBRATION?
The process of comparing the response of some instrument or system to a standard instrument or system over some
measurement range.
•To maintain the accuracy and precision of test equipment at all times.
•To ensure highest level of confidence in all measurement that affect materials
disposition decision, with unbroken chain of traceability to national standard.
•To determine whether the equipment is still fit for its intended purpose.
•It is based on the comparison of a primary standard or instrument of known accuracy with
another equipment (to be calibrated)
•It is used to detect, correlate, report or eliminate by adjustment of any variation the accuracy
of the equipment being calibrated.
21. 21
WHAT IS CMP??
Assigning responsibilities for equipment users, equipment managers, quality
assurance personnel, and calibration vendors to help ensure company-wide
consistency and regulation of your processes.
Approving calibration vendors such that they are in compliance with the
guidelines of your Quality System.
Identifying and labeling equipment.
Processing investigations of out of tolerance conditions and other
calibration-related issues that may necessitate corrective action.
Controlling and storing records, including calibration certificates, status
change forms, and calibration SOPs.
22. 22
WHYTOCALIBRATE??
Components age and equipment undergoes changes in temperature or humidity or sustains mechanical
stress, performance degrades. This is called drift. Then test results become unreliable. While drift cannot
be eliminated, it can be detected and either corrected or compensated for through the process of
calibration.
Properly calibrated equipment provides confidence that your products/services meet their specifications.
Calibration : Optimizes resources
Ensures consistency
Ensures measurements and products are compatible with those made elsewhere
By making sure that your measurements are based on international standards, you promote acceptance of your
products/services/results
23. 23
REFERENCESTANDARD & MATERIAL
Reference standard
It shall be calibrated by a body that can provide traceability. Such reference
standard of measurement held by the laboratory shall only be used for calibration.
It shall be calibrated before and after any adjustment
Reference material
Where possible, it shall be traceable to SI units of measurement, or to certified
reference material. Internal reference material shall be checked as far as is
technically and economically practical
24. 24
CALIBRATIONIDENTIFICATION
Status of equipment calibration shall be available and affixed to the equipment
where applicable.
Equipment identification shall bear the following information
Name of equipment
Serial number
Date calibrated
Status
Schedule of next calibration and
Initial/signature of the person who performed the calibration
25. 25
CALIBRATION PROCESS
Calibration process must be managed and executed in a professional manner
A particular place for all calibration operations to take place and keeping all
instruments for calibration
A separate room is preferred:
• Better environmental control
• Better protection against unauthorized handling or use of the calibration
equipment
26. 26
The performance of all calibration operations is assigned as the clear
responsibility of just one person
Calibration procedures, used for quality control functions, are controlled by the
international standards ISO 9000.
27. 27
MAINTENANCE OF RECORDS OF
CALIBRTION
Records will be maintained for all the calibrations done
It should be according to the cGMP
The individual calibration history files will be prepared and maintained for each
instrument
The records will be maintained and stored in the metrology or QA department
28. 28
LABELING
All calibrated equipments are labelled or coded to indicate its status
Labels should be design and made of material suitable to working environment
Following declarations are to be
“calibrated’ “calibration
required” The label
should contain Date of
last calibration
Date of recalibration
made after calibration
Person responsible for calibration
Calibration certificate number.
30. 30
You must periodically calibrate your
instruments. Identify if there is a ‘drift’in
the measurements and eliminate it through
calibration.
There are no such requirements for
validation. It should be performed when
you make any change in the existing
system or when the revalidation period
has reached.
CALIBRATION V
ALIDATION
Calibration assures accuracy of V
alidation provides proof of consistency
measurements. across all the processes, batches of
products or methods being used.
Calibration is a process that ensures that V
alidation is a documented process that
accuracy is maintained in the measurements provides assurance that a product, service
produced by your equipment. or system consistently provides results
within the acceptable criteria.
Calibration performance of any equipment There are no reference standards used in
is compared against a reference standard. validation.
It should be performed as per calibration It should be performed as per the
SOP
. validation protocol.
31. ICH AND WHO GUIDELINES FOR CALIBRATION
AND VALIDATION OF EQUIPMENTS