MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our...
Transcript of MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our...
![Page 1: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/1.jpg)
MODULE 1
QUALIFICATION AND VALIDATION CONCEPTS
![Page 2: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/2.jpg)
1. Elevate our industry to more knowledge,
2. better understanding of our manufacturing systems
3. Focus on what’s important (Critical)
4. More is not better
5. Better technical understanding (Subject Matter Experts)
The objectives of this workshop
![Page 3: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/3.jpg)
1. Elevate our industry to more knowledge,
2. better understanding of our manufacturing systems
3. Focus on what’s important (Critical)
4. More is not better
5. Better technical understanding (Subject Matter Experts)
The objectives of this workshop
![Page 4: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/4.jpg)
1. Elevate our industry to more knowledge,
2. better understanding of our manufacturing systems
3. Focus on what’s important (Critical)
4. More is not better
5. Better technical understanding (Subject Matter Experts)
The objectives of this workshop
![Page 5: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/5.jpg)
1. Elevate our industry to more knowledge,
2. better understanding of our manufacturing systems
3. Focus on what’s important (Critical)
4. More is not better
5. Better technical understanding (Subject Matter Experts)
The objectives of this workshop
![Page 6: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/6.jpg)
1. Elevate our industry to more knowledge,
2. better understanding of our manufacturing systems
3. Focus on what’s important (Critical)
4. More is not better
5. Better technical understanding (Subject Matter Experts)
The objectives of this workshop
![Page 7: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/7.jpg)
QUESTION :
HOW CAN THE GROUPS HELP YOU IN REACHING THESE OBJECTIVES ?
![Page 8: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/8.jpg)
1. You should develop your appropriate systems and procedures and not get “ready to use” procedures.
2. You should develop tools and templates.
This workshop is not a how to do guide
GOOD NEWS : A LOT OF ANSWERS
ARE ALREADY IN …..
![Page 9: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/9.jpg)
1. You should develop your appropriate systems and procedures and not get ready to use procedures.
2. You should develop tools and templates.
This workshop is not a how to do guide
ICH Q10
GOOD NEWS : A LOT OF ANSWERS
ARE ALREADY IN …..
![Page 10: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/10.jpg)
1. Where to go
2. How to go
3. Enablers.
4. Risk assessment
The beauty of ICH Q10
![Page 11: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/11.jpg)
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner
![Page 12: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/12.jpg)
![Page 13: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/13.jpg)
![Page 14: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/14.jpg)
![Page 15: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/15.jpg)
ISO GMP ICH Q8 Ich Q 9
ICH Q10
Pharmaceuticaldevelopment
Quality riskmanagement
InnovationContinuous improvement
Management responsibilities.
Lifecycle
![Page 16: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/16.jpg)
ISO GMP ICH Q8 Ich Q 9
ICH Q10
Regulatory inspection At manufacturing site
![Page 17: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/17.jpg)
![Page 18: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/18.jpg)
![Page 19: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/19.jpg)
• Drug substance development.• Formulation development.• Manufacture of investigational products.• Delivery system development.• Manufacturing process development and scale up• Analythical method development.
![Page 20: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/20.jpg)
• New product transfers during development through manufacturing.• Transfers within or betwinn manufacturing and testing sites for marketed products.
![Page 21: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/21.jpg)
• Acquisition and control of materials• Provision of facilities, utilities and equipment• Production• Quality control and assurance.• Release• Storage• Distribution.
![Page 22: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/22.jpg)
• Retention of documentation• Sample retention• Continued product assessment and reporting
![Page 23: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/23.jpg)
ICH Q10 OBJECTIVES
![Page 24: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/24.jpg)
CAPAInternalAudit
Record Retention
DocumentManagement
PreventiveMaintenance
Facility& Utilities
ComplaintsCalibration
MRP
ManufacturingSystems
Validation
ChangeControl
ManagementReview
LabSystems
HOW QMS INTERFERES WITH
PRODUCT LIFE CYCLE ?
![Page 25: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/25.jpg)
WHAT DO WE HAVE TO REMEMBER ?
![Page 26: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/26.jpg)
REMEMBER THE KEY CONCEPTS :
1. RISK BASED APPROACH.
2. SCIENCE BASED APPROACH.
3. CRITICAL ASPECTS OF MANUFACTURING SYSTEMS
4. QUALITY BY DESIGN
5. GOOD ENGINEERING PRACTICES
6. SUBJECT MATTER EXPERT
7. USE OF VENDOR DOCUMENTATION
8. CONTINUOUS PROCESS IMPROVEMENT
ASTM E2500
Q8 Q9
![Page 27: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/27.jpg)
REMEMBER THE KEY CONCEPTS :
1 RISK BASED APPROACH.
ASTM E2500
Q8 Q9
APPLIED APPROPRIATELY AT EACH STAGE
BASED ON SCIENTIFIC KNOWLEDGE
PROTECTION OF THE PATIENT
![Page 28: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/28.jpg)
REMEMBER THE KEY CONCEPTS :
2 SCIENCE BASED APPROACH.
ASTM E2500
Q8 Q9
CONSIDER CRITICAL QUALITY ATTRIBUTES CQA
CRITICAL PROCESS PARAMETERS CPK
![Page 29: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/29.jpg)
2 SCIENCE BASED APPROACH.
CRITICAL QUALITY ATTRIBUTES CQA
Process and equipment capability : CPK
![Page 30: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/30.jpg)
2 SCIENCE BASED APPROACH.
CRITICAL QUALITY ATTRIBUTES CQA
Process and equipment capability : CPK
In process improvement efforts, the process capability index or process capability ratio is a statistical measure of process capability: the ability of a process to produce output within specification limits.
Wikipedia
Use of statisticsUse of
statistics
![Page 31: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/31.jpg)
2 SCIENCE BASED APPROACH.
Wikipedia
Use of statisticsUse of
statistics
ENABLER
![Page 32: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/32.jpg)
REMEMBER THE KEY CONCEPTS :
2 SCIENCE BASED APPROACH.
ASTM E2500
Q8 Q9
CONSIDER CRITICAL PROCESS PARAMETERS CPP
![Page 33: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/33.jpg)
REMEMBER THE KEY CONCEPTS :
2 SCIENCE BASED APPROACH.
ASTM E2500
Q8 Q9
CONSIDER CRITICAL PROCESS PARAMETERS CPP
STATISTICAL TRENDING
IN « BEST IN CLASS » IT IS NOT SUFFICIENT TO DEMONSTRATE THATTHE SYSTEM IS UNDER CONTROL « WITHIN ITS CRITICAL PARAMETERS INFLUENCING THE CRITICAL QUALITY ATTRIBUTES » BUT IT IS GOOD PRACTICE TO MONITOR THE STATISTICAL TRENDING.
IS MY PROCESS DRIFTING ?
![Page 34: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/34.jpg)
REMEMBER THE KEY CONCEPTS :
2 SCIENCE BASED APPROACH.
ASTM E2500
Q8 Q9
AGAIN : SCIENCE AND STATISTICS ARE ENABLERS TO HELP YOU CONTROLLING AND PREDICTING YOUR PROCESS
ENABLER
![Page 35: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/35.jpg)
REMEMBER THE KEY CONCEPTS :
3 CRITICAL ASPECTS OF MANUFACTURING SYSTEMS
ASTM E2500
Q8 Q9
VERIFICATION ACTIVITIES SHOULD FOCUS ON THESE ASPECTS AND SHOULD
BE DOCUMENTED
![Page 36: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/36.jpg)
REMEMBER THE KEY CONCEPTS :
4 QUALITY BY DESIGN
ASTM E2500
Q8 Q9
CRITICAL ASPECTS ARE DESIGNED INTO SYSTEMS DURING THE
SPECIFICATIONS AND DESIGN PROCESS.... ASSOCIATED WITH ACCEPTANCE CRITERIA
ASSURANCE THAT MANUFACTURING SYSTEMS ARE FIT FOR INTENDED USE SHOULD NOT RELY SOLELY UPON VERIFICATION AFTER INSTALLATION BUT BE ACHIEVED BY A PLANNED AND STRUCTURED VERIFICATION APPROACH APPLIED THROUGHOUT THE SYSTEM LIFE CYCLE;
![Page 37: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/37.jpg)
REMEMBER THE KEY CONCEPTS :
5 GOOD ENGINEERING PRACTICES
ASTM E2500
Q8 Q9
ESTABLISHED ENGINEERING METHODS AND STANDARDS THAT ARE APPLIED
THROUGHOUT THE LIFE CYCLE TO DELIVER APPROPRIATE AND EFFECTIVE
SOLUTIONS
![Page 38: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/38.jpg)
REMEMBER THE KEY CONCEPTS :
6 SUBJECT MATTER EXPERT
ASTM E2500
Q8 Q9
INDIVIDUALS WITH SPECIFIC EXPERTISE AND RESPONSIBILITY IN A PARTICULAR AREA OR FIELD :
- ENGINEERING- QUALITY- AUTOMATION- OPERATIONS- ...
![Page 39: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/39.jpg)
REMEMBER THE KEY CONCEPTS :
7 USE OF VENDOR DOCUMENTATION
ASTM E2500
Q8 Q9
VENDOR DOCUMENTATION INCLUDING TEST DOCUMENTS MAY BE USED AS PART OF THE VERIFICATION DOCUMENTATION PROVIDING THE REGULATED COMPANY HAS ASSESSED THE VENDOR AND HAS EVIDENCE OF :
ACCEPTABLE VENDOR QUALITY SYSTEM
VENDOR TECHNICAL CAPABILITY
VENDOR APPLICATION OF GEP
![Page 40: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/40.jpg)
REMEMBER THE KEY CONCEPTS :
8 CONTINUOUS PROCESS IMPROVEMENT
ASTM E2500
Q8 Q9
OPORTUNITY FOR IMPROVEMENT SHOULD BE SOUGHT BASED ON PERIODIC
REVIEW AND EVALUATION, OPERATIONAL AND PERFORMANCE DATA, AND
ROOT-CAUSE ANALYSIS OF FAILURE.
CHANGE MANAGEMENT SHOULD PROVIDE A DEPENDABLE MECHANISM FOR
PROMPT IMPLEMENTATION....
![Page 41: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/41.jpg)
ROOT-CAUSE ANALYSIS OF FAILURE
DO YOU MAKE ROOT CAUSE ANALYSIS
OF FAILURE ?
![Page 42: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/42.jpg)
TRICK – FOR ROUTE CAUSE ANALYSIS OF FAILURE
THE 6 WHY
![Page 43: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/43.jpg)
EX : WE FAILED A MEDIA FILL
WHY 1 : BECAUSE WE HAD A POLLUTION ON A FILLING NEEDLE
WHY 2 : BECAUSE WE HAD A BAD STEAM STERILIZATION
WHY 3 : BECAUSE THE STEAM FLOW WAS NOT BALANCED PROPERLY
WHY 4 : BECAUSE WE CHANGED A NEEDLE BEFORE THE STERILIZATION
WHY 5 : BECAUSE THE NEW NEEDLE WAS SLIGHTHY DIFFERENT
WHY 6 : BECAUSE THE NEEDLE DRAWING WAS NOT CORRECT
![Page 44: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/44.jpg)
ACHIEVE PRODUCT REALISATION
To establish, implement and maintain a system that allows the delivery of productsWith the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities and other internal or external customers.
Objective one
![Page 45: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/45.jpg)
ESTABLISH AND MAINTAIN A STATE OF CONTROL
To develop and use effective monitoring and control systems for processperformance and product quality, therebyproviding assurance of continued suitabilityand capability of processes.Quality risk management can be useful in identifying the monitoring and control systems.
Objective two
![Page 46: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/46.jpg)
ESTABLISH AND MAINTAIN A STATE OF CONTROL
To develop and use effective monitoring and control systems for processperformance and product quality, therebyproviding assurance of continued suitabilityand capability of processes.Quality risk management can be useful in identifying the monitoring and control systems.
ENABLER
Objective two
![Page 47: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/47.jpg)
ENABLER :
A tool or process which provides the meansto achieve an objective
![Page 48: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/48.jpg)
ENABLER :
A tool or process which provides the meansto achieve an objective
![Page 49: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/49.jpg)
ENABLER :
A tool or process which provides the meansto achieve an objective
Can you list 5 toolswhich are enablers in Your daily activities ?
![Page 50: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/50.jpg)
ENABLER :
A tool or process which provides the meansto achieve an objective
FMEASUBJECT MATTER EXPERTS
![Page 51: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/51.jpg)
ENABLER :
A tool or process which provides the meansto achieve an objective
![Page 52: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/52.jpg)
ENABLER :
A tool or process which provides the meansto achieve an objective
Can you list 5 processeswhich are enablers in Your daily activities ?
![Page 53: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/53.jpg)
ENABLER :
A tool or process which provides the meansto achieve an objective
Validation plans.Procedures....
![Page 54: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/54.jpg)
FACILITATE CONTINUAL IMPROVEMENT
To identify and implement product qualityimprovements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancement, thereby increasing the ability to fulfil quality needs consistently.
Objective three
![Page 55: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/55.jpg)
FACILITATE CONTINUAL IMPROVEMENT
To identify and implement product qualityimprovements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancement, thereby increasing the ability to fulfil quality needs consistently.
Objective three
![Page 56: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/56.jpg)
FACILITATE CONTINUAL IMPROVEMENT
To identify and implement product qualityimprovements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancement, thereby increasing the ability to fulfil quality needs consistently.
Objective three
![Page 57: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/57.jpg)
FACILITATE CONTINUAL IMPROVEMENT
To identify and implement product qualityimprovements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancement, thereby increasing the ability to fulfil quality needs consistently.
Objective three
![Page 58: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/58.jpg)
FACILITATE CONTINUAL IMPROVEMENT
To identify and implement product qualityimprovements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancement, thereby increasing the ability to fulfil quality needs consistently.
Objective three
![Page 59: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/59.jpg)
FACILITATE CONTINUAL IMPROVEMENT
To identify ...... consistently.
Quality risk management can be useful for identifying and prioritising areas for continual improvement.
Objective three
![Page 60: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/60.jpg)
FACILITATE CONTINUAL IMPROVEMENT
To identify ...... consistently.
Quality risk management can be useful for identifying and prioritising areas for continual improvement.
Objective three
How can Quality RiskManagement help in identifying and prioritising continualimprovement ?
![Page 61: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/61.jpg)
• Acquiring.• Analysing.• Storing.• Dissiminating
Knowledge management
INFORMATION RELATEDTO PRODUCTS
![Page 62: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/62.jpg)
Knowledge management
INFORMATION RELATEDTO PRODUCTS
• Public domain.• Pharmaceutical development studies.• Technology transfer activities.• Process validation studies.• Manufacturing experience.• Innovation.• Continual improvement• Change management
![Page 63: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/63.jpg)
How is my companyorganized to acquire, analyse, store and dissiminate knowledge ?
![Page 64: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/64.jpg)
Knowledge management
• Public domain.• Pharmaceutical development
studies.• Technology transfer activities.• Process validation studies.• Manufacturing experience.• Innovation.• Continual improvement• Change management
• Regulatory affairs.• R&D
• Technical support dpt• Technical support dpt• Manufacturing dpt• R&D• Quality dpt• Quality dpt
![Page 65: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/65.jpg)
Quality risk management
Provide a proactive approach to identifying, scientifically evaluating and controllingpotential risks to quality.
ICH Q9
![Page 66: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/66.jpg)
Risk Management must be integrated intothe Quality Management Systems
�����
![Page 67: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/67.jpg)
1. Minimum essentials
2. Manageable approach
3. One Size. . .
4. Risk & requirements
5. Risk-Based procedures
6. Incremental risk assessments
7. Into current processes
8. Of little value if . . .
Quality risk management –What to remember
What to remember ?
![Page 68: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/68.jpg)
- Identify problems- Evaluate causes- Estimate consequences- Define & implement safeguards
Take away
![Page 69: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/69.jpg)
1. Minimum essentials
2. Manageable approach
3. One Size. . .
4. Risk & requirements
5. Risk-Based procedures
6. Incremental risk assessments
7. Into current processes
8. Of little value if . . .
Quality risk management –What to remember
What not to do ?
![Page 70: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/70.jpg)
It is not a one person activity.
The team must have a good knowledge : Involve the subject matter experts.
If it is not followed by MITIGATION strategy supported by management it is a waste of energy.
It must be implemented, verified and followed by a responsible person reporting to management.
It must follow a PDCA rule.
![Page 71: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/71.jpg)
NOT TO DODo not push Risk Management beyond
common sense you must
- Define an approach that is maintainable
- Scale the effort based on criticality and complexity
![Page 72: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/72.jpg)
DESIGN
QUALIFICATION
VALIDATION
COMMISSIONING
DIRECT IMPACT ?YES NO
![Page 73: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/73.jpg)
73
DIRECT IMPACT ?
![Page 74: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/74.jpg)
74
How to determine that a system has a direct impact and therefore is Critical ?
Can you write down 5 questions to determine if the system has a direct impact ?
Example : Is the system in contact with the product?(syringe)
15 minutes
![Page 75: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/75.jpg)
YY
Y
Y
Y
Y
Y
Y
N
N
N
N
N
N
DIRECTINDIRECT
11
2
3
4
5
6
7
![Page 76: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/76.jpg)
•The table before is the rationale to explain why a process parameters has been identified as non-critical.
•A non critical parameter is also called a « generalparameter »
REMEMBER
![Page 77: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/77.jpg)
DESIGN
1. IN LINE WITH URS2. WILL DRIVE THE FUNCTIONAL SPECIFICATIONS.3. WILL DEFINE THE OPERATIONAL RANGE4. WILL DEFINE THE EXPECTED PERFORMANCES.5. WILL INCLUDE THE RISK ASSESSMENT.6. WILL INCLUDE THE MITIGATION OUTPUTS.7. WILL INCLUDE THE STANDARDS.8. WILL INCLUDE THE GOOD PRACTICES
![Page 78: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/78.jpg)
QUALIFICATION
1. WILL BRING DOCUMENTED EVIDENCE THAT THE EQUIPMENT OR SYSTEM DELIVERED IS IN CONFORMITY WITH :1. URS2. SPECS3. STANDARDS4. INSTALLED CORRECTLY5. DOCUMENTED CORRECTLY6. INSPECTED AND TESTED CORRECTLY7. WILL INCLUDE TRAINING PLAN
![Page 79: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/79.jpg)
VALIDATION
1. WILL BRING DOCUMENTED EVIDENCE THAT THE EQUIPMENT OR SYSTEM DELIVERED IS IN CONFORMITY WITH :1. EXPECTED PERFORMANCES.2. EXPECTED REGULATORY CONSTRAINS.3. SAFE AND PREDICTIBLE.4. ACCEPTANCE CRITERIA5. INTEGER DURING ALL THE LIFE CYCLE
![Page 80: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/80.jpg)
•IQ : Process of obtaining and documenting evidence that the equipment has been provided and installed in accordance with its specifications and is operating in accordance with the process.
Installation qualification
REMEMBER
![Page 81: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/81.jpg)
Periodic re Validation
REMEMBER
•Even If a system is suitably designed, qualified, operated and maintained, it needs to be re evaluated periodically and eventually re-validated.
•Annual review•Re validation program
![Page 82: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/82.jpg)
COMMISSIONING
1. WILL BRING DOCUMENTED EVIDENCE THAT THE EQUIPMENT OR SYSTEM DELIVERED IS IN CONFORMITY WITH :1. PURCHASE ORDER2. URS3. SPECIFICATIONS
![Page 83: MODULE 1 - DCVMN...1. Elevate our industry to more knowledge, 2. better understanding of our manufacturing systems 3. Focus on what’s important (Critical) 4. More is not better 1.](https://reader034.fdocuments.in/reader034/viewer/2022042301/5ecc4a84605884719c086bfc/html5/thumbnails/83.jpg)