This document discusses validation, which is the process of establishing documented evidence that a system will consistently produce a product meeting its quality standards. It defines validation according to WHO and FDA and outlines the merits and scope of validation. It also discusses validation concepts like the validation master plan, V model, qualification processes for design, installation, operation and equipment, change control, and WHO guidelines for equipment validation. The types of validation covered are prospective, concurrent, retrospective and revalidation.
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
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
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
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.
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
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.
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.
Validation.
Validation is establishing documented evidence which provides a high degree of assurances that a specific process or equipment will consistently produce a product or result meeting its predetermined specifications and quality attributes”.
A system must be qualified to operate in a validated process
The results of analytical procedures should be:
— reliable
— accurate
— reproducible
The characteristics that should be considered during validation of analytical methods are:
— specificity
— linearity
— range
— accuracy
— precision
— detection limit
— quantitation limit
— robustness
PHARMACEUTICAL CALIBRATION & VALIDATION.
What is Validation?
What is calibration?
What are the types of Validation ?
Validation and calibration Basic Difference
validation is an important documentation protocol used in most of the laboratories and industries which is used for validation and evaluating different research protocols and equipment used in product formulation and development
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
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
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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.
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.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
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Free of customs clearance, Double Clearance 100% pass delivery to USA, Canada, Spain, Germany, Netherland, Poland, Italy, Sweden, UK, Czech Republic, Australia, Mexico, Russia, Ukraine, Kazakhstan.Door to door service
Hot Selling Organic intermediates
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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!
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
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.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
1. Presented to:
Prof. H.S. keerthy
Department of Pharmaceutics
MALLIGE COLLEGE OF PHARMACY
Presented By:
Manikant Prasad Shah
Mpharm II Sem.
validation
2. WHAT IS VALIDATION?
According to WHO-
It is the establishment of documented evidence that a
system it is supposed to do.
According to US FDA-
The process of establishing documented evidence
which provides a high degree of assurance that a
specific process will consistently produce a product
with its predetermined specifications and quality
attributes.
3. Merits of validation:
1. Assurance of quality compliance.
2. Optimization of resources and manufacture
product at lowest possible cost.
3. Fewer failures, fewer rejects, fewer retests,
fewer reworks, fewer wastage.
4. It is a practice that must be followed for
manufacturing, distribution, selling or license.
5. Efficient production operation.
4. Scope of validation:
Selection of raw material i.e. raw materials of desired quality
attributes
Product design based on the expected performance
Process design to build the desired quality attributes in the
product
Design of control parameters, such as change control, acceptance
criteria, tolerance limits, etc.
In process quality control parameters and sampling plans
Finished product testing or evaluation criteria
Validation of related analytical process
Validation of related system, facility and equipment
Personnel training
Validation involves careful determination of criteria variable of the
process , such as moisture content of granules, drying
temperature of time, etc. and then establishment of acceptable
range and tolerance limit for the same. A careful and continuous
control of these variables will ensure consistent product quality,
5. Relationship between validation and
qualification:
Qualification and validation are essentially the same.
The term qualification is normally used for equipment
and utilities, and validation is for systems and
processes. In this sense, qualification can be seen as
part of validation.
6. Validation Master plan-
A Validation Master Plan is a document that
summarises the firm’s overall philosophy,
intention and approaches to be used for
establishing performance adequacy.
A tool to track progress
Assignment of responsibility and team work
It identifies acceptance criteria before the start of
validation
8. Urs, fat & sat:
User Requirement Specifications- Manufacturers
should prepare a document that describes, for
example, the utility or equipment to be sourced.
The requirements and specifications for the utility
or equipment should be defined by the user and
documented in the URS.
Factory Acceptance Test and Site Acceptance
Test- Where appropriate, FAT and SAT should be
performed to verify the suitability of the system at
site, prior to the subsequent stages of
qualification. This should be appropriately
documented.
9. WHO guidelines for validation of
equipment:
1. All equipment, instruments and other devices used
to measure the physical properties of substances
must be regularly calibrated, validated and verified.
2. Specific procedures must be established for each
type of equipment, instrument and other device,
having regard to the extent to which they are used,
verified and calibrated at regular intervals according
to the SOP.
For example:
(a) pH meters are verified with standard certified buffer
solutions at least once a day;
(b) infrared spectrophotometers require verification at
least once a day and calibration at regular intervals.
10. 3. Only authorized personnel should operate equipment,
instruments and devices. Up-to-date instructions must
be there.
Includes any relevant manuals (provided by the
manufacturer) must be readily available for use by the
appropriate laboratory personnel (e.g. a copy of these
instructions should be placed beside each apparatus,
together with a schedule of the dates on which it is due
for verification and/or calibration). The results of the
verification must be recorded on a control chart, forming
the basis for the timing of calibration.
4. Each item of equipment, instrument or other device
used for testing, verification and calibration must,
when practicable, be uniquely identified.
11. 5. Records must be kept of each item of equipment, instrument or
other device used to perform testing, verification and/or calibration. The
records must include at least the following:
a) the identity of the equipment, instrument or other device;
b) the manufacturer’s name, the type identification, serial number or
other unique identification;
c) the verification and/or calibration required to comply with the
specifications;
d) the current location, where appropriate
e) the manufacturer’s instructions, if available, or an indication of their
location;
f) the dates, results and copies of reports, verifications and certificates
of all calibrations, adjustments, acceptance criteria, and the due date
of the next verification and/or calibration;
g) the maintenance carried out to date and the maintenance plan;
h) a history of any damage, malfunction, modification or repair.
13. Types of validation:
1. Prospective validation-
Establishing documented evidences during
development stage of process based on a
predefined protocol.
It is done prior to distribution of a new product or
whenever there is a major change in the product
characteristics.
Compulsory for sterile products.
The activity continues till the first 3 batches are
manufactures at full scale.
14. Steps in prospective validation:
1. Formation of validation team
2. Preparation of validation master plan and validation
protocol
3. Formulation development (preformulation studies and
optimization)
4. Process development (process design, control &
challenges in critical parameters etc.)
5. Facility development (building, support systems, staff)
6. Process qualification (checked for worst case
conditions o ensure reproducibility)
7. Product qualification
8. Change control
15. 2. Concurrent Process validation-
Carried out during normal production.
It is useful only if process is well understood
during development stage.
The nature and specifications of subsequent in-
process and final tests are based on the
evaluation of the results of such monitoring.
16. 3. Retrospective process validation (based on analysis of
historical data)-
Carried out on the basis of database generated during
previous production of the product.
Recorded difficulties, variation and failures in production
are analysed to determine the limits of process
parameters.
Thus, it is useful in establishing priorities for validation.
17. 4. Revalidation-
It is needed to ensure that the changes in process or in
process environment do not adversely affect the
process characteristic and product quality.
Revalidation is required when:-
a) There is major change in facility, equipment, process
etc.
b) Periodic revalidation is scheduled at regular interval to
control and identify a gradual change in the process.
19. Design qualification-
Design Qualification protocol is used at the stage
where a design that has been developed from
the VMP / URS / cGMP etc, is reviewed and
documented by competent persons to ensure that
the designed equipment, if built, will satisfy all the
detailed specified requirements, as contained in
the VP and URS.
20. Installation qualification:
defined by the FDA as, establishing by objective evidence
that all key aspects of the process equipment and ancillary
system installation adhere to the manufacturer’s approved
specification. It includes:-
I. Examining documentation of equipment design,
identification no., description etc
II. Establishment of critical support system(air, ventilation,
electricity, drainage etc)
III. Ancillary equipments, spare parts are also accounted
IV. Design of SOPs for operation, calibration, maintenance,
cleaning. Reference nos. are given to them.
V. Log books are prepared
VI. Details of the preventive maintenance procedure is
documented.
Before OQ, IQ datas are reviewed and approved.
21. Operational qualification:
The Operational Qualification Protocol is a collection of test cases
used to verify the proper functioning of a system. The operational
qualification test requirements are defined in the Functional
Requirements Specification. Operational Qualification is usually
performed before the system is released for use. It includes:-
I. Tests are done in normal conditions and worst case conditions
II. Testing procedure is prepared
III. Sampling plan is established and verified using a placebo batch
IV. Checks and calibration of sensors, probes, gauges, recorders,
pressure, temperature etc
V. Requirements for training of personnel involves is identified and
training schedule is finalized and documented.
The completion of satisfactory IQ and OQ permits a formal release
of equipments for the next stage.
22. Process qualification:
Process qualification is the qualification of
manufacturing and production processes to
confirm they are able to operate at a certain
standard during commercial manufacturing.
Data covering critical process parameters must
be recorded and analyzed to ensure critical
quality attributes can be guaranteed throughout
production.
Once all processes have been qualified the
manufacturer should have a complete
understanding of the process design and have a
framework in place to routinely monitor
operations. Only after process qualification has
been completed can the manufacturing process
23. Equipment approval:
Once approved, the equipment is handed over to
project co-ordinator by project manager.
All engineering and technical documents are handed
over to the operating department.
24. Change control:
Process may be subjected to changes like change in
the spare part of an equipment that can affect product
quality; so criteria for acceptance is decided and its
implementation procedure is established.
25. References:
Pharmaceutical Process Validation; Wachter H.
Alfred; Nash Robert; Marcel Dekker Inc.; vol 129;
3rd edition; New York
http://www.who.int/medicines/areas/quality_safety
/quality_assurance/validation-2016_05_17.pdf
WHO Technical report, no. 902, 36th report
Pharmaceutical Master Validation Plan; Haider
Imitiaz;1st Indian Reprint