Enviar búsqueda
Cargar
Managing risk in cleaning validation
•
4 recomendaciones
•
5,726 vistas
Institute of Validation Technology
Seguir
Salud y medicina
Denunciar
Compartir
Denunciar
Compartir
1 de 49
Descargar ahora
Descargar para leer sin conexión
Recomendados
New EU Requirements for Qualification & Validation
New EU Requirements for Qualification & Validation
GMP EDUCATION : Not for Profit Organization
Packaging material vendor audit
Packaging material vendor audit
RavichandraNadagouda
Presentation: Cleaning Validation
Presentation: Cleaning Validation
TGA Australia
Cleaning Validation by- Deepak Kumar.
Cleaning Validation by- Deepak Kumar.
Deepak Kumar
ICH Guideline – Q9
ICH Guideline – Q9
rx_sonali
Vendor Audites
Vendor Audites
Nikita Amane
GMP Training: Process validation
GMP Training: Process validation
Dr. Amsavel A
Equipment qualification
Equipment qualification
Institute of Validation Technology
Recomendados
New EU Requirements for Qualification & Validation
New EU Requirements for Qualification & Validation
GMP EDUCATION : Not for Profit Organization
Packaging material vendor audit
Packaging material vendor audit
RavichandraNadagouda
Presentation: Cleaning Validation
Presentation: Cleaning Validation
TGA Australia
Cleaning Validation by- Deepak Kumar.
Cleaning Validation by- Deepak Kumar.
Deepak Kumar
ICH Guideline – Q9
ICH Guideline – Q9
rx_sonali
Vendor Audites
Vendor Audites
Nikita Amane
GMP Training: Process validation
GMP Training: Process validation
Dr. Amsavel A
Equipment qualification
Equipment qualification
Institute of Validation Technology
Vendor Audit
Vendor Audit
PRAVADA
Audit and regulatory Compliance.pptx
Audit and regulatory Compliance.pptx
manoharkasde123
CDER
CDER
Mahesh Marathe
qualification of lcms
qualification of lcms
Ankush Sule
GMP Introduction
GMP Introduction
Rajendra Sadare
ICH Q9 Quality Risk Management
ICH Q9 Quality Risk Management
Seetharam Kandarpa ASQ CMQ/OE, CPGP, CQA
Product quality review
Product quality review
GMP EDUCATION : Not for Profit Organization
Cleaning validation a complete know how
Cleaning validation a complete know how
Sambhujyoti Das
ICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk Management
muna_ali
Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)
Guru Balaji .S
Pharmaceutical validation
Pharmaceutical validation
DhruviParmar
USFDA guidelines on process validation a life cycle approach
USFDA guidelines on process validation a life cycle approach
Rx Ayush Sharma
Validation Boot Camp
Validation Boot Camp
Institute of Validation Technology
Good Automated Manufacturing Practices
Good Automated Manufacturing Practices
Prashant Tomar
Quality System and Audit.pptx
Quality System and Audit.pptx
Dr. Dinesh Mehta
Quality by Design and Process Analytical Technology
Quality by Design and Process Analytical Technology
chandnichandarana1
Ipqc presentation
Ipqc presentation
Manglesh sharma
Pharmaceutical Quality Management System
Pharmaceutical Quality Management System
Syed Muhammad Danish
Cleaning validation
Cleaning validation
Shoab Malek (Certified Quality Auditor)
Statistical Process Control Part 2
Statistical Process Control Part 2
Malay Pandya
0311 cg biology
0311 cg biology
vagaykennedy
4 MAZING a wrightwayventure 2014-2015
4 MAZING a wrightwayventure 2014-2015
Darrell Wright
Más contenido relacionado
La actualidad más candente
Vendor Audit
Vendor Audit
PRAVADA
Audit and regulatory Compliance.pptx
Audit and regulatory Compliance.pptx
manoharkasde123
CDER
CDER
Mahesh Marathe
qualification of lcms
qualification of lcms
Ankush Sule
GMP Introduction
GMP Introduction
Rajendra Sadare
ICH Q9 Quality Risk Management
ICH Q9 Quality Risk Management
Seetharam Kandarpa ASQ CMQ/OE, CPGP, CQA
Product quality review
Product quality review
GMP EDUCATION : Not for Profit Organization
Cleaning validation a complete know how
Cleaning validation a complete know how
Sambhujyoti Das
ICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk Management
muna_ali
Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)
Guru Balaji .S
Pharmaceutical validation
Pharmaceutical validation
DhruviParmar
USFDA guidelines on process validation a life cycle approach
USFDA guidelines on process validation a life cycle approach
Rx Ayush Sharma
Validation Boot Camp
Validation Boot Camp
Institute of Validation Technology
Good Automated Manufacturing Practices
Good Automated Manufacturing Practices
Prashant Tomar
Quality System and Audit.pptx
Quality System and Audit.pptx
Dr. Dinesh Mehta
Quality by Design and Process Analytical Technology
Quality by Design and Process Analytical Technology
chandnichandarana1
Ipqc presentation
Ipqc presentation
Manglesh sharma
Pharmaceutical Quality Management System
Pharmaceutical Quality Management System
Syed Muhammad Danish
Cleaning validation
Cleaning validation
Shoab Malek (Certified Quality Auditor)
Statistical Process Control Part 2
Statistical Process Control Part 2
Malay Pandya
La actualidad más candente
(20)
Vendor Audit
Vendor Audit
Audit and regulatory Compliance.pptx
Audit and regulatory Compliance.pptx
CDER
CDER
qualification of lcms
qualification of lcms
GMP Introduction
GMP Introduction
ICH Q9 Quality Risk Management
ICH Q9 Quality Risk Management
Product quality review
Product quality review
Cleaning validation a complete know how
Cleaning validation a complete know how
ICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk Management
Pharmaceutical process validation (PV)
Pharmaceutical process validation (PV)
Pharmaceutical validation
Pharmaceutical validation
USFDA guidelines on process validation a life cycle approach
USFDA guidelines on process validation a life cycle approach
Validation Boot Camp
Validation Boot Camp
Good Automated Manufacturing Practices
Good Automated Manufacturing Practices
Quality System and Audit.pptx
Quality System and Audit.pptx
Quality by Design and Process Analytical Technology
Quality by Design and Process Analytical Technology
Ipqc presentation
Ipqc presentation
Pharmaceutical Quality Management System
Pharmaceutical Quality Management System
Cleaning validation
Cleaning validation
Statistical Process Control Part 2
Statistical Process Control Part 2
Destacado
0311 cg biology
0311 cg biology
vagaykennedy
4 MAZING a wrightwayventure 2014-2015
4 MAZING a wrightwayventure 2014-2015
Darrell Wright
Branded Sales Playbooks for Loan Officers
Branded Sales Playbooks for Loan Officers
My Home Pro Network
Técnicas de comprensión de textos y organizadores visuales
Técnicas de comprensión de textos y organizadores visuales
Elizabeth Carhuamaca
PRESENTACIÓN DE COMUNIDAD DE PRÁCTICA PEDAGÓGICA
PRESENTACIÓN DE COMUNIDAD DE PRÁCTICA PEDAGÓGICA
Elizabeth Carhuamaca
CC Portfolio-small
CC Portfolio-small
Joey Lam
Fda validation inspections
Fda validation inspections
Institute of Validation Technology
Responding to common patterns of student thinking in mathematics
Responding to common patterns of student thinking in mathematics
xsmseo
Yourprezi1
Yourprezi1
Mscjulperez
Sw week14 b
Sw week14 b
s1200016
Choreography: Solo Pictures
Choreography: Solo Pictures
chrissie2012
Las reformas-estructurales-durante-el-gobierno-militar (1)
Las reformas-estructurales-durante-el-gobierno-militar (1)
Elizabeth Carhuamaca
CC Portfolio-small
CC Portfolio-small
Joey Lam
Sw week14 b
Sw week14 b
s1200016
Perry el ornitorrinco blog
Perry el ornitorrinco blog
Anonimatoanonimo
A WrightWay Venture
A WrightWay Venture
Darrell Wright
Competència lectora 1
Competència lectora 1
Pepa_Psicopedagia
Destacado
(17)
0311 cg biology
0311 cg biology
4 MAZING a wrightwayventure 2014-2015
4 MAZING a wrightwayventure 2014-2015
Branded Sales Playbooks for Loan Officers
Branded Sales Playbooks for Loan Officers
Técnicas de comprensión de textos y organizadores visuales
Técnicas de comprensión de textos y organizadores visuales
PRESENTACIÓN DE COMUNIDAD DE PRÁCTICA PEDAGÓGICA
PRESENTACIÓN DE COMUNIDAD DE PRÁCTICA PEDAGÓGICA
CC Portfolio-small
CC Portfolio-small
Fda validation inspections
Fda validation inspections
Responding to common patterns of student thinking in mathematics
Responding to common patterns of student thinking in mathematics
Yourprezi1
Yourprezi1
Sw week14 b
Sw week14 b
Choreography: Solo Pictures
Choreography: Solo Pictures
Las reformas-estructurales-durante-el-gobierno-militar (1)
Las reformas-estructurales-durante-el-gobierno-militar (1)
CC Portfolio-small
CC Portfolio-small
Sw week14 b
Sw week14 b
Perry el ornitorrinco blog
Perry el ornitorrinco blog
A WrightWay Venture
A WrightWay Venture
Competència lectora 1
Competència lectora 1
Similar a Managing risk in cleaning validation
Managing risk in cv
Managing risk in cv
Institute of Validation Technology
Managing risk in cv
Managing risk in cv
Institute of Validation Technology
CBI Anti-Counterfeiting Presentation
CBI Anti-Counterfeiting Presentation
AlanClock
Analytical method validation raaj gprac [compatibility mode]
Analytical method validation raaj gprac [compatibility mode]
Rajashri Survase Ojha
Analytical method validation raaj gprac [compatibility mode]
Analytical method validation raaj gprac [compatibility mode]
Rajashri Survase Ojha
IMPLEMENTATION OF QUALITY CONTROL PERFORMANCE CRITERIA AND APPROVED GUIDELINE...
IMPLEMENTATION OF QUALITY CONTROL PERFORMANCE CRITERIA AND APPROVED GUIDELINE...
Moustafa Rezk
NABL ACCREDITATION
NABL ACCREDITATION
Teny Thomas
Formulation Solution @ Aizant
Formulation Solution @ Aizant
Jaydeep Adhikari
validation. chemical and biological evaluation, cleaning validation, personal...
validation. chemical and biological evaluation, cleaning validation, personal...
Sharath Hns
Quality Management Services
Quality Management Services
RCM Technologies
Cleaning Validation in Pharmaceutical Manufacturing - A Regulatory Perspectiv...
Cleaning Validation in Pharmaceutical Manufacturing - A Regulatory Perspectiv...
Obaid Ali / Roohi B. Obaid
Clean In Place Technlogies BioPharma Facilities
Clean In Place Technlogies BioPharma Facilities
Ranjeet Kumar
Hplc validation sud mpharm
Hplc validation sud mpharm
Dr. Sudheer Kumar Kamarapu
MABs Stability – Analytical Techniques
MABs Stability – Analytical Techniques
Pharmaxo
Quality System Expectations : Single-Use Materials
Quality System Expectations : Single-Use Materials
gueste42f6b5
Daily Production Management - 5 Tips to Maintain Stability & Exclusion of Abn...
Daily Production Management - 5 Tips to Maintain Stability & Exclusion of Abn...
Antonius Pompi Bramono
Root cause analysis tool
Root cause analysis tool
Mohit Singla
Validation by Vilegave Kailash, Shivajirao S. Jondhle college of Pharmacy Asa...
Validation by Vilegave Kailash, Shivajirao S. Jondhle college of Pharmacy Asa...
Kailash Vilegave
Cleaning validation
Cleaning validation
Vinay Jain
Siva biotech
Siva biotech
shivakumar muthusamy
Similar a Managing risk in cleaning validation
(20)
Managing risk in cv
Managing risk in cv
Managing risk in cv
Managing risk in cv
CBI Anti-Counterfeiting Presentation
CBI Anti-Counterfeiting Presentation
Analytical method validation raaj gprac [compatibility mode]
Analytical method validation raaj gprac [compatibility mode]
Analytical method validation raaj gprac [compatibility mode]
Analytical method validation raaj gprac [compatibility mode]
IMPLEMENTATION OF QUALITY CONTROL PERFORMANCE CRITERIA AND APPROVED GUIDELINE...
IMPLEMENTATION OF QUALITY CONTROL PERFORMANCE CRITERIA AND APPROVED GUIDELINE...
NABL ACCREDITATION
NABL ACCREDITATION
Formulation Solution @ Aizant
Formulation Solution @ Aizant
validation. chemical and biological evaluation, cleaning validation, personal...
validation. chemical and biological evaluation, cleaning validation, personal...
Quality Management Services
Quality Management Services
Cleaning Validation in Pharmaceutical Manufacturing - A Regulatory Perspectiv...
Cleaning Validation in Pharmaceutical Manufacturing - A Regulatory Perspectiv...
Clean In Place Technlogies BioPharma Facilities
Clean In Place Technlogies BioPharma Facilities
Hplc validation sud mpharm
Hplc validation sud mpharm
MABs Stability – Analytical Techniques
MABs Stability – Analytical Techniques
Quality System Expectations : Single-Use Materials
Quality System Expectations : Single-Use Materials
Daily Production Management - 5 Tips to Maintain Stability & Exclusion of Abn...
Daily Production Management - 5 Tips to Maintain Stability & Exclusion of Abn...
Root cause analysis tool
Root cause analysis tool
Validation by Vilegave Kailash, Shivajirao S. Jondhle college of Pharmacy Asa...
Validation by Vilegave Kailash, Shivajirao S. Jondhle college of Pharmacy Asa...
Cleaning validation
Cleaning validation
Siva biotech
Siva biotech
Más de Institute of Validation Technology
Incorporate Domestic and International Regulations for Effective GMP Auditing
Incorporate Domestic and International Regulations for Effective GMP Auditing
Institute of Validation Technology
Notification Tactics for Improved Notification Tactics For Improved Field Act...
Notification Tactics for Improved Notification Tactics For Improved Field Act...
Institute of Validation Technology
Lifecycle Approach to Cleaning Validation
Lifecycle Approach to Cleaning Validation
Institute of Validation Technology
Computer System Validation Then and Now — Learning Management in the Cloud
Computer System Validation Then and Now — Learning Management in the Cloud
Institute of Validation Technology
Applying QbD to Biotech Process Validation
Applying QbD to Biotech Process Validation
Institute of Validation Technology
Management Strategies to Facilitate Continual Quality Improvement
Management Strategies to Facilitate Continual Quality Improvement
Institute of Validation Technology
Understand the Evolving Regulations for Aseptic Cleaning and Environmental Mo...
Understand the Evolving Regulations for Aseptic Cleaning and Environmental Mo...
Institute of Validation Technology
Effective Use of Environmental Monitoring Data Trending
Effective Use of Environmental Monitoring Data Trending
Institute of Validation Technology
Mock Inspection Case Studies
Mock Inspection Case Studies
Institute of Validation Technology
Validation Master Plan
Validation Master Plan
Institute of Validation Technology
Designing Stability Studies for Early Stages of Pharmaceutical Development
Designing Stability Studies for Early Stages of Pharmaceutical Development
Institute of Validation Technology
Determine Exceptions to Validation
Determine Exceptions to Validation
Institute of Validation Technology
Conduct a Gap Analysis of a Validation Programme
Conduct a Gap Analysis of a Validation Programme
Institute of Validation Technology
FDA Inspection
FDA Inspection
Institute of Validation Technology
Incorporate CPV and Continual Improvement into your Validation Plan
Incorporate CPV and Continual Improvement into your Validation Plan
Institute of Validation Technology
Compliance by Design and Compliance Master Plan
Compliance by Design and Compliance Master Plan
Institute of Validation Technology
Introduction to Statistical Applications for Process Validation
Introduction to Statistical Applications for Process Validation
Institute of Validation Technology
Risk-Based Approaches in GMP’s Project Life Cycles
Risk-Based Approaches in GMP’s Project Life Cycles
Institute of Validation Technology
GMP Systems Integration–Combine Results and Utilize as a Compliance Tool
GMP Systems Integration–Combine Results and Utilize as a Compliance Tool
Institute of Validation Technology
A Lifecycle Approach to Process Validation
A Lifecycle Approach to Process Validation
Institute of Validation Technology
Más de Institute of Validation Technology
(20)
Incorporate Domestic and International Regulations for Effective GMP Auditing
Incorporate Domestic and International Regulations for Effective GMP Auditing
Notification Tactics for Improved Notification Tactics For Improved Field Act...
Notification Tactics for Improved Notification Tactics For Improved Field Act...
Lifecycle Approach to Cleaning Validation
Lifecycle Approach to Cleaning Validation
Computer System Validation Then and Now — Learning Management in the Cloud
Computer System Validation Then and Now — Learning Management in the Cloud
Applying QbD to Biotech Process Validation
Applying QbD to Biotech Process Validation
Management Strategies to Facilitate Continual Quality Improvement
Management Strategies to Facilitate Continual Quality Improvement
Understand the Evolving Regulations for Aseptic Cleaning and Environmental Mo...
Understand the Evolving Regulations for Aseptic Cleaning and Environmental Mo...
Effective Use of Environmental Monitoring Data Trending
Effective Use of Environmental Monitoring Data Trending
Mock Inspection Case Studies
Mock Inspection Case Studies
Validation Master Plan
Validation Master Plan
Designing Stability Studies for Early Stages of Pharmaceutical Development
Designing Stability Studies for Early Stages of Pharmaceutical Development
Determine Exceptions to Validation
Determine Exceptions to Validation
Conduct a Gap Analysis of a Validation Programme
Conduct a Gap Analysis of a Validation Programme
FDA Inspection
FDA Inspection
Incorporate CPV and Continual Improvement into your Validation Plan
Incorporate CPV and Continual Improvement into your Validation Plan
Compliance by Design and Compliance Master Plan
Compliance by Design and Compliance Master Plan
Introduction to Statistical Applications for Process Validation
Introduction to Statistical Applications for Process Validation
Risk-Based Approaches in GMP’s Project Life Cycles
Risk-Based Approaches in GMP’s Project Life Cycles
GMP Systems Integration–Combine Results and Utilize as a Compliance Tool
GMP Systems Integration–Combine Results and Utilize as a Compliance Tool
A Lifecycle Approach to Process Validation
A Lifecycle Approach to Process Validation
Último
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
Dipal Arora
Call Girls Faridabad Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Faridabad Just Call 9907093804 Top Class Call Girl Service Available
Dipal Arora
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
Taniya Sharma
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Genuine Call Girls
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
parulsinha
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
narwatsonia7
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
vidya singh
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
Dipal Arora
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
tanya dube
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Call Girls in Nagpur High Profile
Call Girls Siliguri Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Siliguri Just Call 9907093804 Top Class Call Girl Service Available
Dipal Arora
Call Girls Visakhapatnam Just Call 9907093804 Top Class Call Girl Service Ava...
Call Girls Visakhapatnam Just Call 9907093804 Top Class Call Girl Service Ava...
Dipal Arora
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
AlinaDevecerski
Call Girls Aurangabad Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Aurangabad Just Call 9907093804 Top Class Call Girl Service Available
Dipal Arora
Call Girls Tirupati Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Tirupati Just Call 9907093804 Top Class Call Girl Service Available
Dipal Arora
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
jageshsingh5554
Call Girls Jabalpur Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Jabalpur Just Call 9907093804 Top Class Call Girl Service Available
Dipal Arora
💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...
💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...
Taniya Sharma
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
narwatsonia7
Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...
Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...
Dipal Arora
Último
(20)
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Faridabad Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Faridabad Just Call 9907093804 Top Class Call Girl Service Available
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Call Girls Siliguri Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Siliguri Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Visakhapatnam Just Call 9907093804 Top Class Call Girl Service Ava...
Call Girls Visakhapatnam Just Call 9907093804 Top Class Call Girl Service Ava...
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Call Girls Aurangabad Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Aurangabad Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Tirupati Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Tirupati Just Call 9907093804 Top Class Call Girl Service Available
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
Call Girls Jabalpur Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Jabalpur Just Call 9907093804 Top Class Call Girl Service Available
💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...
💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...
Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...
Managing risk in cleaning validation
1.
MANAGING RISK IN
CLEANING VALIDATION Michael Gietl Technical Service Specialist STERIS Corporation michael_gietl@steris.com Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
2.
Agenda • Regulatory background •
Risk identification – Residues – Sampling – Analytical methods – Microbial considerations – Limits • Grouping • Risk Management Tools Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
3.
Cleaning Validation Master
Plan Equipment Cleaning SOP Critical Process Characterization Definition Parameters Product Product Characteristics Grouping Equipment Train Definition Cleaning Agent Residue Use Matrix Selection Sampling Method Selection Equipment Hard to Clean Sampling Sites Grouping Locations Limits Methods Definition Validation Hold Time Definition Recovery Studies Engineering Hard to Clean Worst Case Runs Locations Definition Protocol Definition, Execution, and Summary Report Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
4.
Why Clean? • Possible
Reasons – My boss said I have to do it – The FDA/EMEA won’t approve my product without it – I need job security – It might be fun (?) • REAL Reasons – Reduce possibility of product contamination – Demonstrate cleaning process is consistent – Demonstrate cleaning process removes residues and environmental contaminants – Provide equipment that can be safely reused Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
5.
Cleaning Validation • “Documented
evidence that an approved cleaning procedure will consistently reduce active pharmaceutical ingredients (API), process residues, cleaning agents and microbial residues from product contact equipment surfaces to acceptable levels for the processing of drug products” – Reference: FDA; Guide to Inspections Validation of Cleaning Processes, 1993 Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
6.
Regulatory Requirements • Worldwide
GMPs – EU Annex 15 (Paragraph 36) (2006) & GMP Part II (formerly Appendix 18) (2005) – US FDA, Guide to Inspections of Validation of Cleaning Processes (1993) – Pharmaceutical Inspection Convention (PIC/S), Recommendations on…Cleaning Validation (2001) – WHO Technical Report No. 937: WHO Supplementary Guidelines on GMP (Annex 4): Validation (2006) Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
7.
RISK IDENTIFICATION Copyright
© 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
8.
Types of Soils •
Potential Residues for consideration: – API (Drug substance) – Excipients / Colorants / Dyes / Fragrances / Flavors – Preservatives – Degradants / Impurities – Starting materials / Processing aids – Mother liquors / Solvents – Lubricants – Bioburden – Mycoplasma / Prions / Viral particles – Endotoxin Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
9.
Cleaning Chemistry • Cleaning
depends on process control… Time Action Concentration / Chemistry Temperature • Cleaning also depends on cleaning conditions… – Water Quality – Individual Performing Cleaning (esp. in manual cleaning) – Nature of Soil – Surface being cleaned • Coupon/beaker studies Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
10.
Understanding Your Soils •
Which materials represent the greatest risk to the next process • Is there justification to look for one residue as a “worst case” when compared to other selected residues? – Cleanability – Toxicity – Solubility • In water? – Stability Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
11.
Sampling • Sampling locations
should be selected based on: – Hard to clean locations or complex geometries (hot spots) – Locations that might disproportionately contribute residue to the next product – Materials of construction or surface finishes with an affinity for the soil – The role in the process that is likely to lead to build-up or difficult to remove soils • Number of locations? Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
12.
Sampling Methods
Parameter Swab Rinse Placebo Physical Removal Good Poor Moderate Technique Dependent Yes No No Hard to reach locations Poor Good Good Adaptable to irregular Moderate Good Moderate surfaces Controlled Area Yes No No Non-Invasive No Yes Yes Adaptable to on-line No Yes No monitoring Can use solvents Yes Yes No Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
13.
Identify and Define
Sampling Methods • Swabs – area to be used • Rinse – define and qualify method • Microbial – recovery? • Blanks and controls – handling & methodology • Sample locations – ID – Justification – Risk rationale Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
14.
Analytical Methods • Analytical
methods are preferred to be specific to the analyte • Non-specific methods may be used provided that all analyte identified is attributed to the worst case residue limit • Analytical methods and sampling methods must be demonstrated to be suitable through methods validation in conjunction with the sampling method / extraction system and through recovery studies Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
15.
Microbiological Residues • Bioburden
and endotoxin contaminants should be considered when required to be limited in the final product • Important considerations – Environmental conditions • Guidance for limits taken from: – Product Specifications – Historical data Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
16.
Residue Limits • FDA
Guide to Inspection of Cleaning Validation (7/1993) – Rationales should be logical, practical, achievable, and verifiable – Sensitivity of analytical methods is critical to establishing valid limits – Three examples given: • 10 ppm • 1/1000 of normal therapeutic dose • Organoleptic levels (e.g. visually clean) Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
17.
Residue Limits • Fourmen
and Mullen approach for active: – Most stringent of dose calculation and 10 ppm (in next product) AND – Visually clean • PIC/S Approach: – Most stringent of… • Dose calculation in next product • 10 ppm in next product • Visually clean Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
18.
Residue Limits • Possible
uses of “limit” – Daily amount allowed (ADI or ADE) – Concentration in next product – Absolute amount in manufacturing vessel/train (MAC or MACO – maximum allowable carryover) – Amount per surface area – Amount per swab – Concentration in swab extract solution – Concentration in rinse solution Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
19.
Residue Limits • Need
to determine how much product we just cleaned will be administered to each patient taking the next product – How much will that represent in the next batch? – How much will that represent on the surface? – Need the residual amount to be “safe”, add safety factor – Need to recognize variability in manufacturing process that may change from lot to lot and incorporate into the strategy Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
20.
The Three Types
of Limits • Limits associated with the nature of the substance being cleaned (pharmacological properties) • Limits associated with the percentage of contamination (10 ppm, for example) • Limits associated with the process by which the material is manufactured, cleaned, or analyzed (e.g. visibly clean) Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
21.
Calculating Residue Limits •
Limit in subsequent product (L1) Minimum Daily Dose of Active in Product A 1 L1 = × Maximum Daily Dose of Product B 1,000 • Safety factor (in this case) is 1,000 Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
22.
Minimum Daily Dose
of Active in Product A • How much of the product we just cleaned (Product A) – May be expressed as one of the following: • Toxicity or LD50 (with appropriate safety factor) • Therapeutic Dosage • Allergenic Level • Minimum pharmacological effect level • NOEL (No Observable Effect Level) – Most Conservative Approach Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
23.
Maximum Daily Dose
of Product B • Amount that will be administered to each patient taking the next product (Product B) – The amount of the next product that may be administered – Always most conservative to over-estimate this term Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
24.
Safety Factor Term •
We want the amount of residual soil to be “safe”, therefore may add a safety factor – Safety factor is any convenient number, usually a factor of 10 (e.g. 100, 1000, 10000) – Safety factor is optional in some cases (not optional when using terms such as LD50) – The greater the safety factor, the larger the reduction in the limit Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
25.
Safety Factor Term (Continued) •
One option is to apply safety factors uniformly within a plant – Topical Products: 10 to 100* – Oral Dosage Products: 100 to 1000* – Parenteral/Opthalmic Products: 1,000 to 10,000 – Research/Investigational Products: 10,000 to 100,000 (Hall, W.A. 1997. Cleaning for bulk pharmaceuticals chemicals. In Validation of bulk pharmaceutical chemicals) *Note: Significant rationale must be given if safety factor is less than the industry-standard 1,000 Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
26.
Calculating Residue Limits •
Limit per Surface Area (L2) (L1)(Batch size of subsequent product)(1,000) L2 = shared equipment surface area • In this case, 1,000 is a conversion factor to account for ppm and to convert kg to µg Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
27.
Batch Term • How
much of the soil will be present in the next batch? – May be expressed as batch size (L or kg) or in the number of doses (1,000,000 tablets for example) – Most conservative to work with smallest possible batch size (worst case) Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
28.
Surface Area Term •
How much of the soil may remain on the surface? – Size of the equipment – May represent full shared or maximum surface area of an equipment train – Conservative approach is to over-estimate surface area of shared equipment Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
29.
Calculating Residue Limits •
Limit in the analyzed sample (L2)(swabbed surface area) L3 = amount desorption solvent • Recovery factor from swab recovery studies may be employed here, or apply to analytical result Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
30.
Limits for Cleaning
Agents • No therapeutic index for cleaning agents • Commonly, only information available is LD50 • LD50 specific to animal model (e.g. rat) and route of administration (e.g. oral, IV) • First calculate either Acceptable Daily Intake (ADI) or No Observed Effect Level (NOEL): ADI = LD50 (mg/kg)× body weight x 1/Safety Factor NOEL = LD50 (mg/kg)×(5.6×10-4) x 60 kg1 1 Doursman and Stara, J. Regulatory Toxicology and Pharmacology, 3, 224-238, 1983 Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
31.
Other Considerations • Route
of administration – Topical, oral, parenteral, etc. • Type of patient likely to receive product – Adult vs. Child • Position / role of equipment in process – Conservative strategies moves one toward a purer product as the product is processed to a finished dosage (e.g. UF/DF skids, fillers) Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
32.
Visually Clean • Visually
clean can be sole acceptance criteria provided: – All critical surfaces (especially those most difficult to clean) can be visually examined – The lowest level of surface residue of the target residue which is consistently judged dirty has been established and documented – The surface acceptance criterion (in µg/cm2) of the target residue has been calculated, and is above the level of surface residue at which a surface is judged visually dirty (visual limit) Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
33.
Visually Clean • Generally
not enough to compare calculated limit to level typically referenced (~4 µg/cm2) – Level should be determined experimentally • Requires consideration of: – Distance of observer from surface – Level of lighting – Angle of lighting Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
34.
Things to Avoid
in Setting Limits • Limits based on analytical assay – LOQ (maybe?) – LOD (never!) • Limits based on compendial water specs • Limit unrelated to target residue • Limits selected arbitrarily • No documentation of rationale or risk ranking for how selected Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
35.
Clean Hold Time
(CHT) and Dirty Hold Time (DHT) • Clean Hold Time – Following cleaning, how long equipment remains “clean” before reuse. – Not concerned with process residue; focus is on controlled storage (bioburden proliferation) • Dirty Hold Time – How long “dirty” equipment can remain dirty prior to cleaning – Generally, longer DHT à increasingly difficult to clean – Be aware of potential changes in active/excipient physicial or chemical properties Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
36.
RISK ASSESSMENT Copyright
© 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
37.
Product Grouping (Matrixing) •
Develop overall approach to cleaning validation for current products and provide framework for future development of cleaning program – Potency: potency of products based on normal daily dose of products • Example: Normal Daily Dose Potency Factor < 5mg 5 5 – 199 mg 4 200 – 400 mg 3 400 – 600 mg 2 600 – 800 mg 1 Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
38.
Product Grouping (2) •
Toxicity: Generally reflects rank of groups in terms of potency. – Example: Product Grouping Toxicity Factor Prescription Products 3 OTC Products 2 Dietary supplements 1 Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
39.
Product Grouping (3) •
Solubility: Solubility of active in water/solvent/ cleaning agent being used to clean equipment • Example: Solubility (From USP) Solubility Factor Very Soluble 1 Freely Soluble 2 Soluble 3 Sparingly Soluble 4 Slightly Soluble 5 V. Slightly Soluble 6 Practically Insoluble 7 Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
40.
Product Grouping (4) •
Cleanability: Represents situation where product may be difficult to clean or high risk to clean because of issues due to the nature of product (other than potency, toxicity, and solubility) • Examples: Coated tablets, extended release products, etc. Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
41.
Product Grouping Cleanability Factor
Description Example 1 Easiest to clean Very soluble tablets; product does not stick to surfaces 2 Average cleaning time/ Uncoated tablets, effort capsules 3 More difficult to clean Coated tablets 4 Very difficult to clean Insoluble actives in ointments/creams 5 Most difficult to clean Dyes that stain equipment, strong odors Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
42.
Example (Dietary Supplements)
Cleanability in Potency -‐ RDA Toxicity Alkaline Total RPN Oral Dosage Form Solubility (ac5ve) (mg) Oral LD50 (mg/kg) Detergent (S×P×T×C) Prac5cally Calcium 7 insoluble 1 800-‐1200 1 6450 2 14 0.050-‐0.2 Chromium 4 Not specified 5 00 2 100-‐400 2 80 Iron 3 Soluble 4 10-‐15 2 319 4 96 Slightly Magnesium 5 soluble 3 270-‐400 1 TD Lo 4722 2 30 Not Potassium 3 soluble 3 specified 1 7200 2 18 Selenium 7 Insoluble 5 0.200 3 4.8 -‐7.0 2 210 Zinc 3 Soluble 4 10-‐15 1 5000 2 24 Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
43.
Equipment Grouping • Similar
equipment design – Materials of construction – Equivalent geometries/design risks – Equivalent “hot spots” and critical sites (sampling sites) • Similar manufacturing process – Role/position in process – Campaign length/dirty hold time • Identical cleaning process – Cleaning agent – TACT – Frequency of cleaning Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
44.
EXAMPLE: DETERMINING WORST-CASE LOCATIONS
IN FERMENTOR Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
45.
1 baffle
2 Spray balls Instrument ports (pH, DO, etc) Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
46.
1. Coverage testing
(riboflavin testing) 2. Instrument/sample port(s) 3. Air-liquid interface 4. Representative surface Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
47.
References & Additional Reading •
Fourman, G.L. and Mullen, M.V., “Determining Cleaning Validation Limits for Pharmaceutical Manufacturing Operations,” Pharmaceutical Technology 17(4), 54-60 (1993). • FDA, 1993, Guide to inspections of validation of cleaning processes. Rockville, MD, USA: Food and Drug Administration, Office of Regulatory Affairs. • Forsyth, R., O’Neill, J.C. and Hartman J.L. (2007) Materials of construction based on recovery data for cleaning validation. Pharmaceutical Technology, Oct., pp. 103–116. • LeBlanc, D.A. (2000) Validated Cleaning Technologies for Pharmaceutical Manufacturing. USA: Interpharm Press. • Verghese, G. and Lopolito, P. (2007) Process Analytical Technology and Cleaning. Contamination Control, Fall 2007, pp. 22–26. • LeBlanc, Destin A. et al., Cleaning Technology for Pharmaceutical Manufacturing Pharmaceutical Technology 17:7, 84-92 (1993). • Points to Consider for Cleaning Validation. PDA Technical Report No. 29. PDA. Bethesda, MD.March 30, 1998. • Forsyth, RJ. et al., Correlation of Visible-Residue Limits with Swab Results for leaning Validation. Pharmaceutical Technology 30 (11), 90-100 (2006). Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
48.
References & Additional Reading
(2) • LeBlanc, Destin A., Issues in Setting Limits for Actives in Bulk Biotech Manufacture. Journal of Validation Technology 15 (1), 71-76 (2009). • Pluta, P (editor). Cleaning and Cleaning Validation Volume I. PDA Books (2009). ISBN 1933722371. • Troy, F., Hold Time Studies: A Lost Parameter for Cleaning Validation. Journal of Validation Technology 13 (3) 206-209 (2007). • Rathore, N. et al., Bench-Scale Characterization of Cleaning Process Design Space for Biopharmaceuticals. BioPharm International 22 (3), 32-44 (2009). • Kendrick, K. et al., Analysis of Degradation Properties of Biopharmaceutical Active Ingredients as Caused by Various Process Cleaning Agents and Temperature. Journal of Validation Technology 15 (3), 69-77 (2009). • *Note: This is not a complete listing, just a guidance to literature the speaker has found to be interesting/beneficial. Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
49.
Questions?
THANK YOU! Copyright © 2012 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.
Descargar ahora