SlideShare a Scribd company logo
1 of 29
MODERN PHARMACEUTICS
Presented by-
ABDUL NAIM
M – Pharm – Pharmaceutics
1-st semester
Validation:- validation is confirmation by examination and the
provision of objective evidence that the particular
requirements for a specific intended use are fulfilled
TYPES OF VALIDATION
THE MAJOR TYPES OF VALIDATION
1. Process validation
2. Cleaning validation
3. Equipment validation (Qualification )
4. Validation of analytical method
Process validation
Definition
• As per FDA Nov,2008, ‘the collection of data from the process design
state throughout production, which establishes scientific evidence
that a process is capable of consistently delivering quality products.
Types of process validation:
Prospective validation
Retrospective validation
Concurrent validation
Revalidation
a. Prospective validation
• Carried out during the development stage by means of a risk analysis
of the production process, which is broken down into individual steps.
• These are then evaluated on the basis of past experience to
determine whether they might lead to critical situations.
b. Concurrent validation
Concurrent validation is validation which is carried out during normal
production.
It is appropriate when:-
• it is more appropriate to validate process during routine production
due to well understanding of process.
• Extensive testing and monitoring ensure the desired quality
characteristics of product with high degree of confidence
C. Retrospective validation
• Retrospective validation involves the examination of past experience
of production on the assumption that composition, procedures, and
equipment remain unchanged
• Such experience and the results of in-process and the final control
tests are then evaluated
• Recorded difficulties and failure in production are analysis to
determine the limit of process parameters
d. Revalidation
• Revalidation is needed to ensure that changes in the process and/or
in the process environment, do not adversely affect process
characteristics and product quality.
• Revalidation may be divided into two broad categories:
 Revalidation after any change having a bearing on product quality.
 Periodic revalidation carried out at scheduled intervals.
2. Cleaning validation
Definition
“A process of attaining and document in sufficient evidence to give
reasonable assurance, given the current state of science and
technology, that the cleaning process under consideration does, and/or
will do, what it purpose to do.”
Objective..
• To minimize cross contamination.
• To determine efficiency of cleaning process
• To do troubleshooting in case problem identified in the cleaning
process and give suggestions to improve the process
3. Equipment validation
Definition :-
• As per FDA, May 1987, ‘Action of proving of providing that any
equipment works correctly and leads to the expected results is
equipment qualification.
• It is not single step activity but instead result from many activities.
4. Validation of analytical method
Definition:-
• “the process by, which it is established, by laboratory studies, that the
performance characteristics of the method meet the requirements for
the intended analytical application.”
Accuracy :
“The closeness of test results obtained by that method to the true
value. This accuracy should be established across its range.”
Precision;
The degree of agreement among individual test results when the
method is applied repeatedly to multiple sampling of a homogenous
VALIDATION OF SOLID DOSAGE FORMS
• The objective of the design and manufacture of the solid dosage
form(tablet, capsule) is to deliver orally by correct amount of drug in
the proper from, over a period of time and in the desired location and
to have its chemical integrity protected to that point.
• The prime objective of any pharmaceutical plant is to manufacture
product of high quality consistently at the lowest possible cost.
• Through a careful design & validation of both the process and
controls, the manufacturer can establish a high degree of confidence
that all manufactured units from successive lots will be acceptable.
• The product quality can be ensured by,
1. Chemical and physical stability
2. Preservation against microbial contamination
3. Uniformity of dose of drug
4. Acceptability to users(prescriber & patient)
5. Suitable packaging and labelling
6. Validation
• Tablets as a dosage form comprises a mixture of active substances and
excipients, usually in powder form, pressed (or) compact in to solid
• The excipients include
1. Binder, glidants and lubricant- to ensure efficient tabletting
2. Disintegrant - to promote tablet break up in the GIT
3. Sweetener/flavour – to enhance taste
4. Pigment – to make the tablet visually attractive
• Polymer coating is often applied to make the tablet :-
1. Smoother
2. Easy to swallow
3. Control the release rate of active ingredients
4. More resistant to environment
5. Extending its shelf life
6. To enhance appearance of the tablet
• The manufacturing of tablet includes extensive powder handling
• The powder must blended for uniformity and converted in to the
dosage from through compression.
• The typical requirement include
1. Weight
2. Blending
3. Mixing/ granulation areas
4. Compression
5. Coating
GOVERNMENT REGULATION
• This emphasis on validation began in the late 1970 s, the requirement
has been set at 1963 as cGMP for finished pharmaceuticals.
• There shall be return procedures for production and process control
designed to assure that the drug products have the identity strength,
quality, purity.
• Validation is considered to be integral part of GMPs essentially
worldwide, compliances with validation requirements is necessary for
obtaining approval to manufacture and to introduce new products.
• The FDA’s cGMP refer to the concepts of the validation in both
sections.
• They state that such control procedure shall be established to
monitor output and to validate the performance of those
manufacturing process that may be responsible for causing variability
in the characteristics of in process materials and drug materials.
• The accuracy, sensitivity, specificity and reproducibility of test
methods employed by the firm shall be established and documented.
• A generally stated requirement for process validation is contained in
the medicinal device GMP regulations.
• Where deviations from device specification could occur as result of
manufacturing process itself.
• There shall be written procedures describing any process controls
necessary to assure conformance to specifications.
Manufacturing process model
Facilities
Facilities for URS(user requirement specification):-
• User requirement specifications may be define as the ,user
department will raise the indent for his requirement regarding
machine ,equipment or software. He will give his requirement in a
one format is called the URS which including the functional and
technical specification for the machine ,equipment or software ,these
specification written is called the URS.
General format for URS :
• Name of organization (URS )
• Date ….
• Name of your department …….
• Location …….
• Name of machine , or software ……
• Purpose of machine ….
• software……….
• Other area impact …..(AHU space )
• SL.NO Parameter Specification
• 1 Name
• 2 Model
• 3 Make
• 4 Capacity
• 5 Calibration
• 6 Spare
• 7 Change part 8 others
• Facilities For Design qualification-(DQ)
• Once the URS is finalized the Engineering department, R&D ,user, QA
department will prepare the design qualification ,which including
drawing ,calculation ,sample & other design document .¨
Manufacturer will study the design ,if the design is ok from the
construction point of view manufacturer will quote to the user . if the
design is not ok from the construction ,national & international point
of view. machine manufacture will prepare new drawing from the
construction as well as legal & user point of view .than these drawing
is send to user for approval.
1 -General
2 -Document approval
3 -Version control
4 -Abbreviation
5 -Objective
6 -Responsibility
7 -URS 8 Equipment
9- DQ review and approval ,etc.
• Facilities Of Installation qualification (IQ)
•Installation qualification is the documented
verification that the system is installed
satisfactory & is compliance with other
appropriate engineering code, manufacturing
and approval specification and that instrument is
calibrated & all service are available & of
adequate .
• IQ protocol
• ¨ Validation file
• ¨ Security access
• ¨ Environment
• ¨ System diagnostics
• ¨ hardware component
• ¨ Instrument installation & calibration
• ¨ Electric power & circuit protection
• ¨ Instrument air supply
• ¨ Loop wiring
• ¨ Hardware configuration
• ¨ Software backup and restoration
• ¨ General system inspection
Facilities Of Operational qualification(OQ):
The computer must be power backup & check to ensure it functioning
correctly .This may be involve observing & recording system status lamp
& rerunning diagnostic check
OQ protocol
• Operator interface & screen display
• ¨ Input/ output signal
• ¨ Data storage ,backup & restore
• ¨ Electrical record &electrical signature
• ¨ System report printout
• ¨ Trend display
• ¨ Alarm event & massages
• ¨ Safety interlocks
• ¨ Control & Monitoring loop wiring
• ¨ Software process logic
• ¨ SOP preparation & approval
• ¨ Power failure & data recovery
Performance qualification(PQ)
Performance qualification is an documented verification that
computerized operation consistently perform as intended in the URS
throughout all the anticipated operating range . Performance
qualification are a collection of test cases used to verify that a system
perform as expected under simulated real world Condition The
performance and equipment for its routine analytical use is check to
ensure that complies with its specification .
types of validation

More Related Content

What's hot

Out of specification shravan
Out of specification shravanOut of specification shravan
Out of specification shravanshravan dubey
 
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCQUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
 
Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP)Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP)GOKULAKRISHNAN S
 
Analytical method validation
Analytical method validationAnalytical method validation
Analytical method validationGaurav Kr
 
STABILITY TESTING DURING PRODUCT DEVELOPMENT
STABILITY TESTING DURING PRODUCT DEVELOPMENTSTABILITY TESTING DURING PRODUCT DEVELOPMENT
STABILITY TESTING DURING PRODUCT DEVELOPMENTAmruta Balekundri
 
IPQC of dosage form in pharmaceutical industry
IPQC of dosage form in pharmaceutical industryIPQC of dosage form in pharmaceutical industry
IPQC of dosage form in pharmaceutical industryKay kay shain marma
 
Technology transfer from R&D to production
Technology transfer from R&D to productionTechnology transfer from R&D to production
Technology transfer from R&D to productionDeepak Shanbhag
 
PHARMACEUTICAL VALIDATION
 PHARMACEUTICAL  VALIDATION PHARMACEUTICAL  VALIDATION
PHARMACEUTICAL VALIDATIONSACHIN C P
 
INTRODUCTION TO QUALITY BY DESIGN (QBD)
INTRODUCTION TO QUALITY BY DESIGN (QBD)INTRODUCTION TO QUALITY BY DESIGN (QBD)
INTRODUCTION TO QUALITY BY DESIGN (QBD)Chetan Pawar 2829
 
Scale up and post approval changes(supac)
Scale up and post approval changes(supac)Scale up and post approval changes(supac)
Scale up and post approval changes(supac)bdvfgbdhg
 
Documentation In Pharmaceutical Industry.pptx
Documentation In Pharmaceutical Industry.pptxDocumentation In Pharmaceutical Industry.pptx
Documentation In Pharmaceutical Industry.pptxsaurabh11102000
 

What's hot (20)

Out of specification shravan
Out of specification shravanOut of specification shravan
Out of specification shravan
 
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCQUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLC
 
Distribution records
Distribution recordsDistribution records
Distribution records
 
Urs,dq, iq,oq,pq
Urs,dq, iq,oq,pqUrs,dq, iq,oq,pq
Urs,dq, iq,oq,pq
 
Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP)Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP)
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
Master formula record
Master formula recordMaster formula record
Master formula record
 
Analytical method validation
Analytical method validationAnalytical method validation
Analytical method validation
 
STABILITY TESTING DURING PRODUCT DEVELOPMENT
STABILITY TESTING DURING PRODUCT DEVELOPMENTSTABILITY TESTING DURING PRODUCT DEVELOPMENT
STABILITY TESTING DURING PRODUCT DEVELOPMENT
 
IPQC of dosage form in pharmaceutical industry
IPQC of dosage form in pharmaceutical industryIPQC of dosage form in pharmaceutical industry
IPQC of dosage form in pharmaceutical industry
 
ICH Guidelines
ICH GuidelinesICH Guidelines
ICH Guidelines
 
Process validation of tablets
Process validation of tabletsProcess validation of tablets
Process validation of tablets
 
Technology transfer from R&D to production
Technology transfer from R&D to productionTechnology transfer from R&D to production
Technology transfer from R&D to production
 
Master formula record
Master formula recordMaster formula record
Master formula record
 
PHARMACEUTICAL VALIDATION
 PHARMACEUTICAL  VALIDATION PHARMACEUTICAL  VALIDATION
PHARMACEUTICAL VALIDATION
 
ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)
 
INTRODUCTION TO QUALITY BY DESIGN (QBD)
INTRODUCTION TO QUALITY BY DESIGN (QBD)INTRODUCTION TO QUALITY BY DESIGN (QBD)
INTRODUCTION TO QUALITY BY DESIGN (QBD)
 
Scale up and post approval changes(supac)
Scale up and post approval changes(supac)Scale up and post approval changes(supac)
Scale up and post approval changes(supac)
 
PROCESS VALIDATION
PROCESS VALIDATIONPROCESS VALIDATION
PROCESS VALIDATION
 
Documentation In Pharmaceutical Industry.pptx
Documentation In Pharmaceutical Industry.pptxDocumentation In Pharmaceutical Industry.pptx
Documentation In Pharmaceutical Industry.pptx
 

Similar to types of validation

Bioprocess Validation
Bioprocess Validation Bioprocess Validation
Bioprocess Validation Pramod Pal
 
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptx
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptxPharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptx
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptxMariaSaifee
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validationMineeta Mahra
 
Pharmaceutical Validation
 Pharmaceutical Validation  Pharmaceutical Validation
Pharmaceutical Validation AmnThakur
 
Validation overview short.pptx
Validation overview short.pptxValidation overview short.pptx
Validation overview short.pptxJitulAdhikary1
 
Pharmaceutical validation.pptx
Pharmaceutical validation.pptxPharmaceutical validation.pptx
Pharmaceutical validation.pptxArpithaNandakumar1
 
Validation overview short.pptx
Validation overview short.pptxValidation overview short.pptx
Validation overview short.pptxJitulAdhikary1
 
Notes for the subject 'Pharmaceutical Validation'
Notes for the subject 'Pharmaceutical Validation' Notes for the subject 'Pharmaceutical Validation'
Notes for the subject 'Pharmaceutical Validation' Sanathoiba Singha
 
Basic concept of process validation
Basic concept of process validation Basic concept of process validation
Basic concept of process validation Bishnu Koirala
 
Validation Of Solid Dosage Forms.
Validation Of Solid Dosage Forms.Validation Of Solid Dosage Forms.
Validation Of Solid Dosage Forms.Ramya priya
 
VALIDATION BY DHIRAJ SHRESTHA
VALIDATION BY DHIRAJ SHRESTHAVALIDATION BY DHIRAJ SHRESTHA
VALIDATION BY DHIRAJ SHRESTHADhiraj Shrestha
 
validation of tablet and capsule formulation8
validation of tablet and capsule formulation8validation of tablet and capsule formulation8
validation of tablet and capsule formulation8tanvikumbhar
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validationamol dighe
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validationamol dighe
 
validationksd-140930004558-phpapp01 (1).pdf
validationksd-140930004558-phpapp01 (1).pdfvalidationksd-140930004558-phpapp01 (1).pdf
validationksd-140930004558-phpapp01 (1).pdfAkashChaudhary749568
 
validation-1.pptx
validation-1.pptxvalidation-1.pptx
validation-1.pptxSridharA50
 

Similar to types of validation (20)

Bioprocess Validation
Bioprocess Validation Bioprocess Validation
Bioprocess Validation
 
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptx
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptxPharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptx
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptx
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validation
 
Validation (1).pptx
Validation (1).pptxValidation (1).pptx
Validation (1).pptx
 
Pharmaceutical Validation
 Pharmaceutical Validation  Pharmaceutical Validation
Pharmaceutical Validation
 
Validation overview short.pptx
Validation overview short.pptxValidation overview short.pptx
Validation overview short.pptx
 
Pharmaceutical validation.pptx
Pharmaceutical validation.pptxPharmaceutical validation.pptx
Pharmaceutical validation.pptx
 
Validation overview short.pptx
Validation overview short.pptxValidation overview short.pptx
Validation overview short.pptx
 
Validation
ValidationValidation
Validation
 
Notes for the subject 'Pharmaceutical Validation'
Notes for the subject 'Pharmaceutical Validation' Notes for the subject 'Pharmaceutical Validation'
Notes for the subject 'Pharmaceutical Validation'
 
Basic concept of process validation
Basic concept of process validation Basic concept of process validation
Basic concept of process validation
 
Jatin validation
Jatin validationJatin validation
Jatin validation
 
Process validation ppt.
Process validation ppt.Process validation ppt.
Process validation ppt.
 
Validation Of Solid Dosage Forms.
Validation Of Solid Dosage Forms.Validation Of Solid Dosage Forms.
Validation Of Solid Dosage Forms.
 
VALIDATION BY DHIRAJ SHRESTHA
VALIDATION BY DHIRAJ SHRESTHAVALIDATION BY DHIRAJ SHRESTHA
VALIDATION BY DHIRAJ SHRESTHA
 
validation of tablet and capsule formulation8
validation of tablet and capsule formulation8validation of tablet and capsule formulation8
validation of tablet and capsule formulation8
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validation
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validation
 
validationksd-140930004558-phpapp01 (1).pdf
validationksd-140930004558-phpapp01 (1).pdfvalidationksd-140930004558-phpapp01 (1).pdf
validationksd-140930004558-phpapp01 (1).pdf
 
validation-1.pptx
validation-1.pptxvalidation-1.pptx
validation-1.pptx
 

More from AbdulNaim14

informed consent process and procedure .pptx
informed consent process and procedure .pptxinformed consent process and procedure .pptx
informed consent process and procedure .pptxAbdulNaim14
 
ICH GUIDELINES.pptx
ICH GUIDELINES.pptxICH GUIDELINES.pptx
ICH GUIDELINES.pptxAbdulNaim14
 
HECKEL PLOT CEUTICS .pptx
HECKEL PLOT CEUTICS .pptxHECKEL PLOT CEUTICS .pptx
HECKEL PLOT CEUTICS .pptxAbdulNaim14
 
global submission of NDA .pptx
global submission of NDA .pptxglobal submission of NDA .pptx
global submission of NDA .pptxAbdulNaim14
 
global submission of ANDA .pptx
global submission of ANDA .pptxglobal submission of ANDA .pptx
global submission of ANDA .pptxAbdulNaim14
 
post approval regulatory affairs
post approval regulatory affairspost approval regulatory affairs
post approval regulatory affairsAbdulNaim14
 

More from AbdulNaim14 (6)

informed consent process and procedure .pptx
informed consent process and procedure .pptxinformed consent process and procedure .pptx
informed consent process and procedure .pptx
 
ICH GUIDELINES.pptx
ICH GUIDELINES.pptxICH GUIDELINES.pptx
ICH GUIDELINES.pptx
 
HECKEL PLOT CEUTICS .pptx
HECKEL PLOT CEUTICS .pptxHECKEL PLOT CEUTICS .pptx
HECKEL PLOT CEUTICS .pptx
 
global submission of NDA .pptx
global submission of NDA .pptxglobal submission of NDA .pptx
global submission of NDA .pptx
 
global submission of ANDA .pptx
global submission of ANDA .pptxglobal submission of ANDA .pptx
global submission of ANDA .pptx
 
post approval regulatory affairs
post approval regulatory affairspost approval regulatory affairs
post approval regulatory affairs
 

Recently uploaded

4.16.24 Poverty and Precarity--Desmond.pptx
4.16.24 Poverty and Precarity--Desmond.pptx4.16.24 Poverty and Precarity--Desmond.pptx
4.16.24 Poverty and Precarity--Desmond.pptxmary850239
 
ICS2208 Lecture6 Notes for SL spaces.pdf
ICS2208 Lecture6 Notes for SL spaces.pdfICS2208 Lecture6 Notes for SL spaces.pdf
ICS2208 Lecture6 Notes for SL spaces.pdfVanessa Camilleri
 
Transaction Management in Database Management System
Transaction Management in Database Management SystemTransaction Management in Database Management System
Transaction Management in Database Management SystemChristalin Nelson
 
How to Manage Buy 3 Get 1 Free in Odoo 17
How to Manage Buy 3 Get 1 Free in Odoo 17How to Manage Buy 3 Get 1 Free in Odoo 17
How to Manage Buy 3 Get 1 Free in Odoo 17Celine George
 
Q-Factor HISPOL Quiz-6th April 2024, Quiz Club NITW
Q-Factor HISPOL Quiz-6th April 2024, Quiz Club NITWQ-Factor HISPOL Quiz-6th April 2024, Quiz Club NITW
Q-Factor HISPOL Quiz-6th April 2024, Quiz Club NITWQuiz Club NITW
 
Expanded definition: technical and operational
Expanded definition: technical and operationalExpanded definition: technical and operational
Expanded definition: technical and operationalssuser3e220a
 
4.11.24 Poverty and Inequality in America.pptx
4.11.24 Poverty and Inequality in America.pptx4.11.24 Poverty and Inequality in America.pptx
4.11.24 Poverty and Inequality in America.pptxmary850239
 
Reading and Writing Skills 11 quarter 4 melc 1
Reading and Writing Skills 11 quarter 4 melc 1Reading and Writing Skills 11 quarter 4 melc 1
Reading and Writing Skills 11 quarter 4 melc 1GloryAnnCastre1
 
4.16.24 21st Century Movements for Black Lives.pptx
4.16.24 21st Century Movements for Black Lives.pptx4.16.24 21st Century Movements for Black Lives.pptx
4.16.24 21st Century Movements for Black Lives.pptxmary850239
 
Indexing Structures in Database Management system.pdf
Indexing Structures in Database Management system.pdfIndexing Structures in Database Management system.pdf
Indexing Structures in Database Management system.pdfChristalin Nelson
 
Mythology Quiz-4th April 2024, Quiz Club NITW
Mythology Quiz-4th April 2024, Quiz Club NITWMythology Quiz-4th April 2024, Quiz Club NITW
Mythology Quiz-4th April 2024, Quiz Club NITWQuiz Club NITW
 
ESP 4-EDITED.pdfmmcncncncmcmmnmnmncnmncmnnjvnnv
ESP 4-EDITED.pdfmmcncncncmcmmnmnmncnmncmnnjvnnvESP 4-EDITED.pdfmmcncncncmcmmnmnmncnmncmnnjvnnv
ESP 4-EDITED.pdfmmcncncncmcmmnmnmncnmncmnnjvnnvRicaMaeCastro1
 
Unraveling Hypertext_ Analyzing Postmodern Elements in Literature.pptx
Unraveling Hypertext_ Analyzing  Postmodern Elements in  Literature.pptxUnraveling Hypertext_ Analyzing  Postmodern Elements in  Literature.pptx
Unraveling Hypertext_ Analyzing Postmodern Elements in Literature.pptxDhatriParmar
 
Active Learning Strategies (in short ALS).pdf
Active Learning Strategies (in short ALS).pdfActive Learning Strategies (in short ALS).pdf
Active Learning Strategies (in short ALS).pdfPatidar M
 
Scientific Writing :Research Discourse
Scientific  Writing :Research  DiscourseScientific  Writing :Research  Discourse
Scientific Writing :Research DiscourseAnita GoswamiGiri
 
Textual Evidence in Reading and Writing of SHS
Textual Evidence in Reading and Writing of SHSTextual Evidence in Reading and Writing of SHS
Textual Evidence in Reading and Writing of SHSMae Pangan
 
Beauty Amidst the Bytes_ Unearthing Unexpected Advantages of the Digital Wast...
Beauty Amidst the Bytes_ Unearthing Unexpected Advantages of the Digital Wast...Beauty Amidst the Bytes_ Unearthing Unexpected Advantages of the Digital Wast...
Beauty Amidst the Bytes_ Unearthing Unexpected Advantages of the Digital Wast...DhatriParmar
 

Recently uploaded (20)

4.16.24 Poverty and Precarity--Desmond.pptx
4.16.24 Poverty and Precarity--Desmond.pptx4.16.24 Poverty and Precarity--Desmond.pptx
4.16.24 Poverty and Precarity--Desmond.pptx
 
ICS2208 Lecture6 Notes for SL spaces.pdf
ICS2208 Lecture6 Notes for SL spaces.pdfICS2208 Lecture6 Notes for SL spaces.pdf
ICS2208 Lecture6 Notes for SL spaces.pdf
 
Mattingly "AI & Prompt Design: Large Language Models"
Mattingly "AI & Prompt Design: Large Language Models"Mattingly "AI & Prompt Design: Large Language Models"
Mattingly "AI & Prompt Design: Large Language Models"
 
Transaction Management in Database Management System
Transaction Management in Database Management SystemTransaction Management in Database Management System
Transaction Management in Database Management System
 
How to Manage Buy 3 Get 1 Free in Odoo 17
How to Manage Buy 3 Get 1 Free in Odoo 17How to Manage Buy 3 Get 1 Free in Odoo 17
How to Manage Buy 3 Get 1 Free in Odoo 17
 
Q-Factor HISPOL Quiz-6th April 2024, Quiz Club NITW
Q-Factor HISPOL Quiz-6th April 2024, Quiz Club NITWQ-Factor HISPOL Quiz-6th April 2024, Quiz Club NITW
Q-Factor HISPOL Quiz-6th April 2024, Quiz Club NITW
 
Expanded definition: technical and operational
Expanded definition: technical and operationalExpanded definition: technical and operational
Expanded definition: technical and operational
 
4.11.24 Poverty and Inequality in America.pptx
4.11.24 Poverty and Inequality in America.pptx4.11.24 Poverty and Inequality in America.pptx
4.11.24 Poverty and Inequality in America.pptx
 
Reading and Writing Skills 11 quarter 4 melc 1
Reading and Writing Skills 11 quarter 4 melc 1Reading and Writing Skills 11 quarter 4 melc 1
Reading and Writing Skills 11 quarter 4 melc 1
 
4.16.24 21st Century Movements for Black Lives.pptx
4.16.24 21st Century Movements for Black Lives.pptx4.16.24 21st Century Movements for Black Lives.pptx
4.16.24 21st Century Movements for Black Lives.pptx
 
Indexing Structures in Database Management system.pdf
Indexing Structures in Database Management system.pdfIndexing Structures in Database Management system.pdf
Indexing Structures in Database Management system.pdf
 
Mythology Quiz-4th April 2024, Quiz Club NITW
Mythology Quiz-4th April 2024, Quiz Club NITWMythology Quiz-4th April 2024, Quiz Club NITW
Mythology Quiz-4th April 2024, Quiz Club NITW
 
Paradigm shift in nursing research by RS MEHTA
Paradigm shift in nursing research by RS MEHTAParadigm shift in nursing research by RS MEHTA
Paradigm shift in nursing research by RS MEHTA
 
ESP 4-EDITED.pdfmmcncncncmcmmnmnmncnmncmnnjvnnv
ESP 4-EDITED.pdfmmcncncncmcmmnmnmncnmncmnnjvnnvESP 4-EDITED.pdfmmcncncncmcmmnmnmncnmncmnnjvnnv
ESP 4-EDITED.pdfmmcncncncmcmmnmnmncnmncmnnjvnnv
 
Unraveling Hypertext_ Analyzing Postmodern Elements in Literature.pptx
Unraveling Hypertext_ Analyzing  Postmodern Elements in  Literature.pptxUnraveling Hypertext_ Analyzing  Postmodern Elements in  Literature.pptx
Unraveling Hypertext_ Analyzing Postmodern Elements in Literature.pptx
 
Active Learning Strategies (in short ALS).pdf
Active Learning Strategies (in short ALS).pdfActive Learning Strategies (in short ALS).pdf
Active Learning Strategies (in short ALS).pdf
 
Scientific Writing :Research Discourse
Scientific  Writing :Research  DiscourseScientific  Writing :Research  Discourse
Scientific Writing :Research Discourse
 
Textual Evidence in Reading and Writing of SHS
Textual Evidence in Reading and Writing of SHSTextual Evidence in Reading and Writing of SHS
Textual Evidence in Reading and Writing of SHS
 
prashanth updated resume 2024 for Teaching Profession
prashanth updated resume 2024 for Teaching Professionprashanth updated resume 2024 for Teaching Profession
prashanth updated resume 2024 for Teaching Profession
 
Beauty Amidst the Bytes_ Unearthing Unexpected Advantages of the Digital Wast...
Beauty Amidst the Bytes_ Unearthing Unexpected Advantages of the Digital Wast...Beauty Amidst the Bytes_ Unearthing Unexpected Advantages of the Digital Wast...
Beauty Amidst the Bytes_ Unearthing Unexpected Advantages of the Digital Wast...
 

types of validation

  • 1. MODERN PHARMACEUTICS Presented by- ABDUL NAIM M – Pharm – Pharmaceutics 1-st semester
  • 2. Validation:- validation is confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled TYPES OF VALIDATION THE MAJOR TYPES OF VALIDATION 1. Process validation 2. Cleaning validation 3. Equipment validation (Qualification ) 4. Validation of analytical method
  • 3. Process validation Definition • As per FDA Nov,2008, ‘the collection of data from the process design state throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Types of process validation: Prospective validation Retrospective validation Concurrent validation Revalidation
  • 4. a. Prospective validation • Carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps. • These are then evaluated on the basis of past experience to determine whether they might lead to critical situations.
  • 5. b. Concurrent validation Concurrent validation is validation which is carried out during normal production. It is appropriate when:- • it is more appropriate to validate process during routine production due to well understanding of process. • Extensive testing and monitoring ensure the desired quality characteristics of product with high degree of confidence
  • 6. C. Retrospective validation • Retrospective validation involves the examination of past experience of production on the assumption that composition, procedures, and equipment remain unchanged • Such experience and the results of in-process and the final control tests are then evaluated • Recorded difficulties and failure in production are analysis to determine the limit of process parameters
  • 7. d. Revalidation • Revalidation is needed to ensure that changes in the process and/or in the process environment, do not adversely affect process characteristics and product quality. • Revalidation may be divided into two broad categories:  Revalidation after any change having a bearing on product quality.  Periodic revalidation carried out at scheduled intervals.
  • 8. 2. Cleaning validation Definition “A process of attaining and document in sufficient evidence to give reasonable assurance, given the current state of science and technology, that the cleaning process under consideration does, and/or will do, what it purpose to do.” Objective.. • To minimize cross contamination. • To determine efficiency of cleaning process • To do troubleshooting in case problem identified in the cleaning process and give suggestions to improve the process
  • 9. 3. Equipment validation Definition :- • As per FDA, May 1987, ‘Action of proving of providing that any equipment works correctly and leads to the expected results is equipment qualification. • It is not single step activity but instead result from many activities.
  • 10. 4. Validation of analytical method Definition:- • “the process by, which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical application.” Accuracy : “The closeness of test results obtained by that method to the true value. This accuracy should be established across its range.” Precision; The degree of agreement among individual test results when the method is applied repeatedly to multiple sampling of a homogenous
  • 11. VALIDATION OF SOLID DOSAGE FORMS • The objective of the design and manufacture of the solid dosage form(tablet, capsule) is to deliver orally by correct amount of drug in the proper from, over a period of time and in the desired location and to have its chemical integrity protected to that point. • The prime objective of any pharmaceutical plant is to manufacture product of high quality consistently at the lowest possible cost. • Through a careful design & validation of both the process and controls, the manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable.
  • 12. • The product quality can be ensured by, 1. Chemical and physical stability 2. Preservation against microbial contamination 3. Uniformity of dose of drug 4. Acceptability to users(prescriber & patient) 5. Suitable packaging and labelling 6. Validation • Tablets as a dosage form comprises a mixture of active substances and excipients, usually in powder form, pressed (or) compact in to solid • The excipients include 1. Binder, glidants and lubricant- to ensure efficient tabletting 2. Disintegrant - to promote tablet break up in the GIT
  • 13. 3. Sweetener/flavour – to enhance taste 4. Pigment – to make the tablet visually attractive • Polymer coating is often applied to make the tablet :- 1. Smoother 2. Easy to swallow 3. Control the release rate of active ingredients 4. More resistant to environment 5. Extending its shelf life 6. To enhance appearance of the tablet
  • 14. • The manufacturing of tablet includes extensive powder handling • The powder must blended for uniformity and converted in to the dosage from through compression. • The typical requirement include 1. Weight 2. Blending 3. Mixing/ granulation areas 4. Compression 5. Coating
  • 15. GOVERNMENT REGULATION • This emphasis on validation began in the late 1970 s, the requirement has been set at 1963 as cGMP for finished pharmaceuticals. • There shall be return procedures for production and process control designed to assure that the drug products have the identity strength, quality, purity. • Validation is considered to be integral part of GMPs essentially worldwide, compliances with validation requirements is necessary for obtaining approval to manufacture and to introduce new products. • The FDA’s cGMP refer to the concepts of the validation in both sections.
  • 16. • They state that such control procedure shall be established to monitor output and to validate the performance of those manufacturing process that may be responsible for causing variability in the characteristics of in process materials and drug materials. • The accuracy, sensitivity, specificity and reproducibility of test methods employed by the firm shall be established and documented. • A generally stated requirement for process validation is contained in the medicinal device GMP regulations. • Where deviations from device specification could occur as result of manufacturing process itself. • There shall be written procedures describing any process controls necessary to assure conformance to specifications.
  • 18. Facilities Facilities for URS(user requirement specification):- • User requirement specifications may be define as the ,user department will raise the indent for his requirement regarding machine ,equipment or software. He will give his requirement in a one format is called the URS which including the functional and technical specification for the machine ,equipment or software ,these specification written is called the URS.
  • 19. General format for URS : • Name of organization (URS ) • Date …. • Name of your department ……. • Location ……. • Name of machine , or software …… • Purpose of machine …. • software………. • Other area impact …..(AHU space )
  • 20. • SL.NO Parameter Specification • 1 Name • 2 Model • 3 Make • 4 Capacity • 5 Calibration • 6 Spare • 7 Change part 8 others
  • 21. • Facilities For Design qualification-(DQ) • Once the URS is finalized the Engineering department, R&D ,user, QA department will prepare the design qualification ,which including drawing ,calculation ,sample & other design document .¨ Manufacturer will study the design ,if the design is ok from the construction point of view manufacturer will quote to the user . if the design is not ok from the construction ,national & international point of view. machine manufacture will prepare new drawing from the construction as well as legal & user point of view .than these drawing is send to user for approval.
  • 22. 1 -General 2 -Document approval 3 -Version control 4 -Abbreviation 5 -Objective 6 -Responsibility 7 -URS 8 Equipment 9- DQ review and approval ,etc.
  • 23. • Facilities Of Installation qualification (IQ) •Installation qualification is the documented verification that the system is installed satisfactory & is compliance with other appropriate engineering code, manufacturing and approval specification and that instrument is calibrated & all service are available & of adequate .
  • 24. • IQ protocol • ¨ Validation file • ¨ Security access • ¨ Environment • ¨ System diagnostics • ¨ hardware component • ¨ Instrument installation & calibration • ¨ Electric power & circuit protection • ¨ Instrument air supply • ¨ Loop wiring
  • 25. • ¨ Hardware configuration • ¨ Software backup and restoration • ¨ General system inspection Facilities Of Operational qualification(OQ): The computer must be power backup & check to ensure it functioning correctly .This may be involve observing & recording system status lamp & rerunning diagnostic check
  • 26. OQ protocol • Operator interface & screen display • ¨ Input/ output signal • ¨ Data storage ,backup & restore • ¨ Electrical record &electrical signature • ¨ System report printout • ¨ Trend display • ¨ Alarm event & massages
  • 27. • ¨ Safety interlocks • ¨ Control & Monitoring loop wiring • ¨ Software process logic • ¨ SOP preparation & approval • ¨ Power failure & data recovery
  • 28. Performance qualification(PQ) Performance qualification is an documented verification that computerized operation consistently perform as intended in the URS throughout all the anticipated operating range . Performance qualification are a collection of test cases used to verify that a system perform as expected under simulated real world Condition The performance and equipment for its routine analytical use is check to ensure that complies with its specification .