QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
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.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
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.
A validation programme involves various components in pharmaceutical organisation related to process, equipment and product.
It is a regulatory requirement for pharmaceutical companies to perform Instrument Validation on all new instruments.
Instrument Validation requires detailed knowledge of the instrumentation system being validated and is therefore usually performed by the company supplying the instrument.
This presentation describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. It is a GMP requirement that manufacturer’s control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed.
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
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Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
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Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
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Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
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This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
3. 3
Safety Review
by NRA
Preclinical R&D
(GMP/GLP)
Clinical Trial
(GCP)
NDA or
Licensure
Post-market
surveillance
Phase 1 Phase 2 Phase 3
STAGES INVOLVED in REGULATING DRUGS
4. 4
The minimal necessary level
of operation and administration
of facilities, methods and controls
To manufacture drug products
of consistently high quality
(to assure that the products meets the requirements of the act
as to safety and effectiveness which the product purports)
GMP(Good Manufacturing Practice)
5. 5
Designation of a Responsible Person
And Independent Quality Assurance Unit
Maintenance of Suitable Facilities
Definition of Scientifically Sound
(Validated) Analytical Methods)
The issuance of a Final Report
Fully Retrievable and Available Raw Data
Use of Calibrated Equipment
Accuracy and precision
Use of well Maintained Equipment
Conducted by Standard Operating Procedures (SOP’s)
Conducted by Qualified Personnel
cGMP Laboratory 21 CFR Ch. 1, Part 211
6. 6
FOUR BASIC ELEMENTS of GMP: “4Ms”FOUR BASIC ELEMENTS of GMP: “4Ms”
Men: adequate training
Materials: raw materials, products, reagents,
labels, containers
Machinery: facilities, systems, equipment
Methods: manufacturing, control, validation,
documentation
7. 7
VALIDATIONVALIDATION
Establishing documented evidence which provides
a high degree of assurance that a specific process
will consistently produce a product meeting its
pre-determined specifications and quality attributes
8. 8
REFERENCESREFERENCES
US FDA
Guideline for general principles of process validation
May, 1987
Guideline on sterile drug products produced by
aseptic processing, June, 1987
WHO
A WHO Guide to GMP, Requirements, Part 2:
Validation, January, 1997
European Commission
Final Version of Annex 15 to the EU Guide to GMP
Title: Qualificaiton and Validation, September, 2001
11. 11
ELEMENTS of VALIDATIONELEMENTS of VALIDATION
Equipment validation: Installation Qualification(IQ)
Operational Qualification(OQ)
Process validation: Performance Qualification(PQ)
12. 12
STEPS INVOLVED in VALIDATIONSTEPS INVOLVED in VALIDATION
Validation master plan
Validation protocol
Execution of validation
Validation report
Preparation of SOPs
13. 13
MAJOR VALIDATION ITEMSMAJOR VALIDATION ITEMS
Steam-sterilization
Depyrogenation
Freeze-drying
Clean in place
Sterilization in place
Purification
Filling
Inactivation
Decontamination
Sterile Filtration(Liquid)
Water for Injection system
Air Handling system
Clean Steam system
14. 14
FDA Guideline Definition…
“PROCESS VALIDATION” is establishing documented evidence
which provides a high degree of assurance that a specific
process consistently produce a product meeting it’s
predetermined specifications and quality attributes”
From….
Guidelines on General Principles of Process Validation
May, 1987. US FDA
PROCESS VALIDATIONPROCESS VALIDATION
16. 16
Validation versus Qualification
VALIDATION:
Refers to the total life cycle of a product from development
through use and maintenance.
Customers(Owners) are responsible for Validating Their
Processes(personnel, equipment, methods, SOPs) to ensure
compliance to CGMP/GLP regulations.
QUALIFICATION: (Inspection, functional testing and documentation review)
Is a part of the validation process which verifies module and
system functional performance prior to being placed on-line
and thereafter according to a standard operating procedure.
VALIDATION vs. QUALIFICATIONVALIDATION vs. QUALIFICATION
17. 17
QUALIFICATION vs. CALIBRATIONQUALIFICATION vs. CALIBRATION
QUALIFICATION CALIBRATION
Qualification Workbooks(IQ, OQ,
PQ) & Project Diskettes
Accuracy, Linearity and
Precision Tests
Appropriate for companies
without approved
qualification procedures
Meets or exceeds US FDA
qualification requirements.
Calibration Protocols
Accuracy Tests Only
Appropriate for companies
that have approved validation
procedures
Basic documentation for
maintenance and calibration
18. 18
The Validation Time Line
Vendor’s
Site
Owner’s site
Before
Purchase
Before Use After Use
Structurally
Validated
Products
DQ
Functional Validation
Installation Operational
Performance
Qualification Qualification
Qualification
Maintenance
OQ
PQIQ OQ PQ
System Suitability During Use
VALIDATION TIME LINEVALIDATION TIME LINE
19. 19
DESIGN QUALIFICATION (DQ)
“A documented review of the design, at an appropriate stage of stages
in the project, for conformance to operational and regulatory
expectations.”
Applies to the Critical Equipment/systems
DQ Check Items
- GMPs and Regulatory Requirements
- Performance Criteria (URS & FS)
- Facility Air Flow, Movement Flow & Pressure Regimes
- Reliability & Efficiency
- Commissioning Requirements
- Construct ability & Installation of Equipment
- Maintenance & Access to Critical Equipment & Instrumentation
- Safety & Environment Impact
20. 20
DQ REVIEW DOCUMENTS
User Requirement Specification (URS)
Functional Specification (FS)
System impact Assessments
Tender Specifications, P&ID’s and Drawings
Vendor Quality procedures and documents
Purchase Specification
21. 21
INSTALLATION QUALIFICATION (IQ)
“Documented verification that all aspects of a facility, utility or
equipment that can affect product quality adhere to approved
specifications and are correctly installed.”
Applies to the Critical Equipment/Systems
Protocols
Purpose
Description
References
Responsibilities
Installation Qualification (Test Plan)
IQ Acceptance Criteria
Modification/ Change Control and Revalidation
Comments/ Action Items
IQ Attachments
22. 22
TEST PLAN (CHECK LISTS)
Identification : Sanitary Vessel Data Sheet
Identification : Agitator Data Sheet
Equipment List
Filters
Materials in Product Contact
Recommended Spare Parts List
Instrument Calibration : Critical Instrument
Instrument Calibration : Reference Instrument
Documentation
Drawings
Piping IQ Check List
Utility Requirement : Electrical
Utility Requirement : Other Utilities
Grounding Checkout
Validation Test Instruments and calibrations
Installation Qualification Summary
Comments/Action Items
23. 23
OPERATIONAL QUALIFICATION (OQ)
“Documented verification that all aspects of a facility, utility or
equipment that can affect product quality operate to Intended
throughout all anticipated ranges.”
Applies to the Critical Equipment/Systems
Protocols
Purpose
Description
References
Responsibilities
Installation Qualification (Test Plan)
OQ Acceptance Criteria
Modification/ Change Control and Revalidation
Comments/ Action Items
OQ Attachments
24. 24
TEST PLAN (CHECK LISTS)
Validation Test Instruments and Calibrations
Alarm checkout
Control Panel Checkout
Pressure Hold Test
Water Batch Test-Agitator System checkout
Water Batch Test-Heating / Cooling System Checkout
Transfer System Check Out
CIP Qualification Check Out
SIP Sterilization Temperature Mapping
SIP Sterilization Filter Integrity Test Results
Filter Adsorption / Component Removal / Release of Extractable
PLC Screen Verification
SOP & Personnel Training
Operational Qualification Summary
Acceptance of New Equipment Form
Comments/Action Items
25. 25
PERFORMANCE QUALIFICATION (PQ)
“Documented verification that all aspects of a facility, utility or equipment
Perform as intended in meeting predetermined acceptance criteria.”
Applies to the Critical Systems (i.e.: HVAC Systems, Pharmaceutical
Grade Water Systems, Clean Compressed Gases, Clean Steam
System,
Process Package Systems)
Protocols
Purpose
Description
References
Responsibilities
Performance Qualification (Test Plan)
PQ Acceptance Criteria
Modification/ Change Control and Revalidation
Comments/ Action Items
PQ Attachments
-Test Data Sheet
-Test Instrument Calibration and Analytical Instrument Validation
26. 26
PERFORMANCE QUALIFICATION (PQ)
PQ Protocol should include the following:
Acceptance criteria
Number of samples for analytical testing
Location of sampling points
Duration of testing
Processing steps for testing
Batch records
Number of runs