SlideShare a Scribd company logo
1 of 21
Download to read offline
Opening Session
(Good Manufacturing Practices & Quality Management System)
Obaid Ali, R. Ph., Ph. D.
18 Feb 2018
CCK - Lahore
Please accept our
Profound regards and all the gratitude
that cannot be translated into words
Prime Health Laboratories
Lahore Medical & Dental College
ALL OF YOU
D
I
S
C
L
A
I
M
E
R
Personal Point
of View
No
Obligation
on DRAP
Knowledge &
Experience
Current
Judgment
This presentation discusses science, nothing
more and nothing less
Learn, Un-learn & Re-learn
Change is the process by which the future invades our lives
Alvin Toffler
If you want to go fast, go alone
If you want to go far,
go together
If the drug qualifies all the tests required for release of drug
What do you think is your drug;
Safe? Effective? Quality?
Assay Dosage
Uniformity
DissolutionSterility Etc. etc.
Safety Efficacy Quality
Testing of drugs is absolutely nothing if
they are not manufactured in a compliant
manufacturing environment
Take Home Message
Set the Tone on Full Compliance Mode
Manufactured in GMP environment
Qualifies all tests
Any other thing required?
Manufacturing in a compliant environment and
its testing does not fulfill the intent without
oversight programs for quality surveillance
Take Home Message
Set the Tone on Full Compliance Mode
Safe, efficacious & have correct
identity
Deliver the same performance as
claimed
Perform consistently over shelf
life
Made in a manner that ensure
quality
Will be available when needed
Patient and
Doctor
assume that
Drugs are
Typically Consumer Can not
see Quality
Can a patient know how it is
manufactured
Trust on Safety, Efficacy & Quality
is not simple but so complex
Panel Discussion
Question Answer
Science & Reference
No free talks or belief
Please discuss to evolve knowledge and catch
Take Home Messages
Speak; Questions always worthy
We will recognize innocent questions and opening questions as a
great stimulus of knowledge managing session

More Related Content

Similar to 1 - Opening Session (GMP & QMS) Lahore

Tutorial - 1: Creating & Sustaining a Culture of Quality
Tutorial - 1: Creating & Sustaining a Culture of QualityTutorial - 1: Creating & Sustaining a Culture of Quality
Tutorial - 1: Creating & Sustaining a Culture of QualityObaid Ali / Roohi B. Obaid
 
75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...
75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...
75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...Obaid Ali / Roohi B. Obaid
 
2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences
2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences
2015 Dashboard of Pharmaceutical & Biologics Regulatory SciencesObaid Ali / Roohi B. Obaid
 
Training Session on Good Manufacturing Practices of the 21st Century
Training Session on Good Manufacturing Practices of the 21st CenturyTraining Session on Good Manufacturing Practices of the 21st Century
Training Session on Good Manufacturing Practices of the 21st CenturyObaid Ali / Roohi B. Obaid
 
60 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, China
60 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, China60 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, China
60 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, ChinaObaid Ali / Roohi B. Obaid
 
Group-A, Day 1: CLINICAL TRIAL, Rising Regulations & Complexities, Pharmaceu...
 Group-A, Day 1: CLINICAL TRIAL, Rising Regulations & Complexities, Pharmaceu... Group-A, Day 1: CLINICAL TRIAL, Rising Regulations & Complexities, Pharmaceu...
Group-A, Day 1: CLINICAL TRIAL, Rising Regulations & Complexities, Pharmaceu...Obaid Ali / Roohi B. Obaid
 
Pharmaceutical Regulaions; Emergence & Complexity
Pharmaceutical Regulaions; Emergence & ComplexityPharmaceutical Regulaions; Emergence & Complexity
Pharmaceutical Regulaions; Emergence & ComplexityObaid Ali / Roohi B. Obaid
 
Good Manufacturing Practice for Pharmaceutical Products.pdf
Good Manufacturing Practice for Pharmaceutical Products.pdfGood Manufacturing Practice for Pharmaceutical Products.pdf
Good Manufacturing Practice for Pharmaceutical Products.pdfMd. Zakaria Faruki
 
Pharmaceutical Scientific and Regulatory Practices (12 April 2017)
Pharmaceutical Scientific and Regulatory Practices (12 April 2017)Pharmaceutical Scientific and Regulatory Practices (12 April 2017)
Pharmaceutical Scientific and Regulatory Practices (12 April 2017)Obaid Ali / Roohi B. Obaid
 

Similar to 1 - Opening Session (GMP & QMS) Lahore (20)

OARO 11 Feb 2017
OARO  11 Feb 2017OARO  11 Feb 2017
OARO 11 Feb 2017
 
Tutorial - 1: Creating & Sustaining a Culture of Quality
Tutorial - 1: Creating & Sustaining a Culture of QualityTutorial - 1: Creating & Sustaining a Culture of Quality
Tutorial - 1: Creating & Sustaining a Culture of Quality
 
Dashboard Review; An Outline 2017
Dashboard Review; An Outline 2017Dashboard Review; An Outline 2017
Dashboard Review; An Outline 2017
 
75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...
75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...
75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...
 
Science behind Trust & Confidence
Science behind Trust & ConfidenceScience behind Trust & Confidence
Science behind Trust & Confidence
 
2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences
2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences
2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences
 
Training Session on Good Manufacturing Practices of the 21st Century
Training Session on Good Manufacturing Practices of the 21st CenturyTraining Session on Good Manufacturing Practices of the 21st Century
Training Session on Good Manufacturing Practices of the 21st Century
 
Claim & Reasonable Probability
Claim & Reasonable ProbabilityClaim & Reasonable Probability
Claim & Reasonable Probability
 
5 of 5 Quality Metrics & Science by Obaid Ali
5 of 5  Quality Metrics & Science by Obaid Ali5 of 5  Quality Metrics & Science by Obaid Ali
5 of 5 Quality Metrics & Science by Obaid Ali
 
GMP and Emerging Phenomena - 29 Sep 2019
GMP and Emerging Phenomena - 29 Sep 2019 GMP and Emerging Phenomena - 29 Sep 2019
GMP and Emerging Phenomena - 29 Sep 2019
 
60 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, China
60 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, China60 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, China
60 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, China
 
Maturing Drug Quality to Deliver Promise
Maturing Drug Quality to Deliver PromiseMaturing Drug Quality to Deliver Promise
Maturing Drug Quality to Deliver Promise
 
Drug Quality .. A Matter of Deep Concern
Drug Quality .. A Matter of Deep ConcernDrug Quality .. A Matter of Deep Concern
Drug Quality .. A Matter of Deep Concern
 
2 - GMP June 2022 - CQS.pdf
2 - GMP June 2022 - CQS.pdf2 - GMP June 2022 - CQS.pdf
2 - GMP June 2022 - CQS.pdf
 
Group-A, Day 1: CLINICAL TRIAL, Rising Regulations & Complexities, Pharmaceu...
 Group-A, Day 1: CLINICAL TRIAL, Rising Regulations & Complexities, Pharmaceu... Group-A, Day 1: CLINICAL TRIAL, Rising Regulations & Complexities, Pharmaceu...
Group-A, Day 1: CLINICAL TRIAL, Rising Regulations & Complexities, Pharmaceu...
 
Harmonization and Opportunites (Nov 2015)
Harmonization and Opportunites (Nov 2015)Harmonization and Opportunites (Nov 2015)
Harmonization and Opportunites (Nov 2015)
 
Pharmaceutical Regulaions; Emergence & Complexity
Pharmaceutical Regulaions; Emergence & ComplexityPharmaceutical Regulaions; Emergence & Complexity
Pharmaceutical Regulaions; Emergence & Complexity
 
1 - Warm up Discussion with Real Case
1 - Warm up Discussion with Real Case1 - Warm up Discussion with Real Case
1 - Warm up Discussion with Real Case
 
Good Manufacturing Practice for Pharmaceutical Products.pdf
Good Manufacturing Practice for Pharmaceutical Products.pdfGood Manufacturing Practice for Pharmaceutical Products.pdf
Good Manufacturing Practice for Pharmaceutical Products.pdf
 
Pharmaceutical Scientific and Regulatory Practices (12 April 2017)
Pharmaceutical Scientific and Regulatory Practices (12 April 2017)Pharmaceutical Scientific and Regulatory Practices (12 April 2017)
Pharmaceutical Scientific and Regulatory Practices (12 April 2017)
 

More from Obaid Ali / Roohi B. Obaid

A Strategic Talk on Biologicals & Biotechnological Products
A Strategic Talk on Biologicals & Biotechnological ProductsA Strategic Talk on Biologicals & Biotechnological Products
A Strategic Talk on Biologicals & Biotechnological ProductsObaid Ali / Roohi B. Obaid
 
Centre for Quality Sciences-Information File-2024.pdf
Centre for Quality Sciences-Information File-2024.pdfCentre for Quality Sciences-Information File-2024.pdf
Centre for Quality Sciences-Information File-2024.pdfObaid Ali / Roohi B. Obaid
 
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
Demonstrate your QMS during Inspection-30 Sep 2023.pdfDemonstrate your QMS during Inspection-30 Sep 2023.pdf
Demonstrate your QMS during Inspection-30 Sep 2023.pdfObaid Ali / Roohi B. Obaid
 
Track, Trace & Understand Science of Life from Real World Evidence.pdf
Track, Trace & Understand Science of Life from Real World Evidence.pdfTrack, Trace & Understand Science of Life from Real World Evidence.pdf
Track, Trace & Understand Science of Life from Real World Evidence.pdfObaid Ali / Roohi B. Obaid
 
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
120th Training Session - Unfortunate Wave of DEG Tragedy.pdfObaid Ali / Roohi B. Obaid
 
Judging Science & Prior Knowledge Beyond the Line
Judging Science & Prior Knowledge Beyond the LineJudging Science & Prior Knowledge Beyond the Line
Judging Science & Prior Knowledge Beyond the LineObaid Ali / Roohi B. Obaid
 

More from Obaid Ali / Roohi B. Obaid (20)

A Strategic Talk on Biologicals & Biotechnological Products
A Strategic Talk on Biologicals & Biotechnological ProductsA Strategic Talk on Biologicals & Biotechnological Products
A Strategic Talk on Biologicals & Biotechnological Products
 
Centre for Quality Sciences-Information File-2024.pdf
Centre for Quality Sciences-Information File-2024.pdfCentre for Quality Sciences-Information File-2024.pdf
Centre for Quality Sciences-Information File-2024.pdf
 
A Tragic Resistance to Learn.pdf
A Tragic Resistance to Learn.pdfA Tragic Resistance to Learn.pdf
A Tragic Resistance to Learn.pdf
 
230930.pdf
230930.pdf230930.pdf
230930.pdf
 
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
Demonstrate your QMS during Inspection-30 Sep 2023.pdfDemonstrate your QMS during Inspection-30 Sep 2023.pdf
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
 
Centre for Quality Sciences-2023
Centre for Quality Sciences-2023Centre for Quality Sciences-2023
Centre for Quality Sciences-2023
 
Track, Trace & Understand Science of Life from Real World Evidence.pdf
Track, Trace & Understand Science of Life from Real World Evidence.pdfTrack, Trace & Understand Science of Life from Real World Evidence.pdf
Track, Trace & Understand Science of Life from Real World Evidence.pdf
 
Confidence on Generics.pdf
Confidence on Generics.pdfConfidence on Generics.pdf
Confidence on Generics.pdf
 
Neurotoxicity & Neurodegenaration.pdf
Neurotoxicity & Neurodegenaration.pdfNeurotoxicity & Neurodegenaration.pdf
Neurotoxicity & Neurodegenaration.pdf
 
Application of Data & AI in Pharma 4
Application of Data & AI in Pharma 4Application of Data & AI in Pharma 4
Application of Data & AI in Pharma 4
 
PICS-ICH
PICS-ICHPICS-ICH
PICS-ICH
 
Quality Affairs of Pharmaceuticals
Quality Affairs of PharmaceuticalsQuality Affairs of Pharmaceuticals
Quality Affairs of Pharmaceuticals
 
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
 
CQS Session - RO - 16 Oct 2022.pdf
CQS Session - RO - 16 Oct 2022.pdfCQS Session - RO - 16 Oct 2022.pdf
CQS Session - RO - 16 Oct 2022.pdf
 
GMP Session for Professional Development.pdf
GMP Session for Professional Development.pdfGMP Session for Professional Development.pdf
GMP Session for Professional Development.pdf
 
Q & A - June - Sep 2022.pdf
Q & A - June - Sep 2022.pdfQ & A - June - Sep 2022.pdf
Q & A - June - Sep 2022.pdf
 
Judging Science & Prior Knowledge Beyond the Line
Judging Science & Prior Knowledge Beyond the LineJudging Science & Prior Knowledge Beyond the Line
Judging Science & Prior Knowledge Beyond the Line
 
PQRS 2022 - Education
PQRS  2022 - EducationPQRS  2022 - Education
PQRS 2022 - Education
 
4 - GMP June 2022 - CQS.pdf
4 - GMP June 2022 - CQS.pdf4 - GMP June 2022 - CQS.pdf
4 - GMP June 2022 - CQS.pdf
 
3 - GMP June 2022 - CQS.pdf
3 - GMP June 2022 - CQS.pdf3 - GMP June 2022 - CQS.pdf
3 - GMP June 2022 - CQS.pdf
 

Recently uploaded

Management 13th Edition by Richard L. Daft test bank.docx
Management 13th Edition by Richard L. Daft test bank.docxManagement 13th Edition by Richard L. Daft test bank.docx
Management 13th Edition by Richard L. Daft test bank.docxssuserf63bd7
 
TEST BANK for Operations Management, 14th Edition by William J. Stevenson,.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson,.pdfTEST BANK for Operations Management, 14th Edition by William J. Stevenson,.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson,.pdfmarcuskenyatta275
 
W.H.Bender Quote 63 You Must Plan T.O.P Take-Out Packaging
W.H.Bender Quote 63 You Must Plan T.O.P Take-Out PackagingW.H.Bender Quote 63 You Must Plan T.O.P Take-Out Packaging
W.H.Bender Quote 63 You Must Plan T.O.P Take-Out PackagingWilliam (Bill) H. Bender, FCSI
 
Spring-2024-Priesthoods of Augustus Yale Historical Review
Spring-2024-Priesthoods of Augustus Yale Historical ReviewSpring-2024-Priesthoods of Augustus Yale Historical Review
Spring-2024-Priesthoods of Augustus Yale Historical Reviewyalehistoricalreview
 
Group work -meaning and definitions- Characteristics and Importance
Group work -meaning and definitions- Characteristics and ImportanceGroup work -meaning and definitions- Characteristics and Importance
Group work -meaning and definitions- Characteristics and Importanceajay0134
 
Leading People - Harvard Manage Mentor Certificate
Leading People - Harvard Manage Mentor CertificateLeading People - Harvard Manage Mentor Certificate
Leading People - Harvard Manage Mentor CertificateVICTOR MAESTRE RAMIREZ
 
Team Dynamics: A Journey to Excellence
Team Dynamics: A Journey to ExcellenceTeam Dynamics: A Journey to Excellence
Team Dynamics: A Journey to ExcellenceGDSC PJATK
 
Marketing Management 16 Global Edition by Philip Kotler test bank.docx
Marketing Management 16 Global Edition by Philip Kotler test bank.docxMarketing Management 16 Global Edition by Philip Kotler test bank.docx
Marketing Management 16 Global Edition by Philip Kotler test bank.docxssuserf63bd7
 
DrupalCamp Atlanta 2022 - Effective Project Management
DrupalCamp Atlanta 2022 - Effective Project ManagementDrupalCamp Atlanta 2022 - Effective Project Management
DrupalCamp Atlanta 2022 - Effective Project ManagementNorah Medlin
 
LECTURE maintenance management is important 1.pptx
LECTURE maintenance management is important 1.pptxLECTURE maintenance management is important 1.pptx
LECTURE maintenance management is important 1.pptxshahzadnasim3
 
Disaster management for class 10 students
Disaster management for class 10 studentsDisaster management for class 10 students
Disaster management for class 10 studentsmadhav072009
 

Recently uploaded (11)

Management 13th Edition by Richard L. Daft test bank.docx
Management 13th Edition by Richard L. Daft test bank.docxManagement 13th Edition by Richard L. Daft test bank.docx
Management 13th Edition by Richard L. Daft test bank.docx
 
TEST BANK for Operations Management, 14th Edition by William J. Stevenson,.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson,.pdfTEST BANK for Operations Management, 14th Edition by William J. Stevenson,.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson,.pdf
 
W.H.Bender Quote 63 You Must Plan T.O.P Take-Out Packaging
W.H.Bender Quote 63 You Must Plan T.O.P Take-Out PackagingW.H.Bender Quote 63 You Must Plan T.O.P Take-Out Packaging
W.H.Bender Quote 63 You Must Plan T.O.P Take-Out Packaging
 
Spring-2024-Priesthoods of Augustus Yale Historical Review
Spring-2024-Priesthoods of Augustus Yale Historical ReviewSpring-2024-Priesthoods of Augustus Yale Historical Review
Spring-2024-Priesthoods of Augustus Yale Historical Review
 
Group work -meaning and definitions- Characteristics and Importance
Group work -meaning and definitions- Characteristics and ImportanceGroup work -meaning and definitions- Characteristics and Importance
Group work -meaning and definitions- Characteristics and Importance
 
Leading People - Harvard Manage Mentor Certificate
Leading People - Harvard Manage Mentor CertificateLeading People - Harvard Manage Mentor Certificate
Leading People - Harvard Manage Mentor Certificate
 
Team Dynamics: A Journey to Excellence
Team Dynamics: A Journey to ExcellenceTeam Dynamics: A Journey to Excellence
Team Dynamics: A Journey to Excellence
 
Marketing Management 16 Global Edition by Philip Kotler test bank.docx
Marketing Management 16 Global Edition by Philip Kotler test bank.docxMarketing Management 16 Global Edition by Philip Kotler test bank.docx
Marketing Management 16 Global Edition by Philip Kotler test bank.docx
 
DrupalCamp Atlanta 2022 - Effective Project Management
DrupalCamp Atlanta 2022 - Effective Project ManagementDrupalCamp Atlanta 2022 - Effective Project Management
DrupalCamp Atlanta 2022 - Effective Project Management
 
LECTURE maintenance management is important 1.pptx
LECTURE maintenance management is important 1.pptxLECTURE maintenance management is important 1.pptx
LECTURE maintenance management is important 1.pptx
 
Disaster management for class 10 students
Disaster management for class 10 studentsDisaster management for class 10 students
Disaster management for class 10 students
 

1 - Opening Session (GMP & QMS) Lahore