The document discusses various aspects of process validation including:
- The three stages of process validation: process design, process qualification, and continued process verification.
- Key definitions related to process validation including qualification, validation, and continued process verification.
- The importance of process validation in ensuring consistent quality and reducing risk.
- Key documents required for stage 1 process design including development reports and control strategy documents.
Quality by Design for Legacy Products - A Contradiction ?Anthony Grenier
This document discusses applying Quality by Design (QbD) principles to both new product development and legacy products throughout the product lifecycle. It describes the three stages of process validation according to FDA guidelines and how QbD can be the basis for process validation. While new products must go through all three stages, legacy products focus on Stage III continued process verification. The document provides examples of how to define critical quality attributes and critical process parameters for legacy products using risk assessments and process knowledge. It also discusses using continued process verification to continuously improve process understanding, control strategies, and product quality over time.
Presentation PIC/S Guide to GMP PE009-13 Annex 15TGA Australia
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
The document discusses the FDA's 2011 guidance on a lifecycle approach to process validation. It begins by explaining the differences between the 1987 guidance and the 2011 guidance, which focuses on three stages: process design, process qualification, and continued process verification. The document then goes into detail about each stage, explaining the goals and key activities of each stage. It provides details on what should be included in process qualification protocols, execution of process qualification, and ongoing activities in continued process verification.
This document discusses validation and the Validation Master Plan (VMP). It provides definitions of validation and qualification, and explains that the VMP outlines the validation strategy, activities, responsibilities, and schedule for a manufacturing organization. The VMP identifies all items, processes, and systems to be validated; defines protocols, acceptance criteria and documentation requirements; and helps management and regulators oversee the validation work. It provides a master plan and map for all validation activities.
This document provides an overview of process validation according to FDA guidance. It defines process validation as collecting data from process design through commercial production to establish that a process is capable of consistently delivering quality products. The guidance outlines a lifecycle approach with three stages: process design, process qualification, and continued process verification. Process design defines the commercial process based on development knowledge. Process qualification evaluates the design and determines if the process is reproducible. Continued process verification ensures the process remains controlled during routine production. Critical quality attributes and critical process parameters are identified, and control strategies are established.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
Quality by Design for Legacy Products - A Contradiction ?Anthony Grenier
This document discusses applying Quality by Design (QbD) principles to both new product development and legacy products throughout the product lifecycle. It describes the three stages of process validation according to FDA guidelines and how QbD can be the basis for process validation. While new products must go through all three stages, legacy products focus on Stage III continued process verification. The document provides examples of how to define critical quality attributes and critical process parameters for legacy products using risk assessments and process knowledge. It also discusses using continued process verification to continuously improve process understanding, control strategies, and product quality over time.
Presentation PIC/S Guide to GMP PE009-13 Annex 15TGA Australia
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
The document discusses the FDA's 2011 guidance on a lifecycle approach to process validation. It begins by explaining the differences between the 1987 guidance and the 2011 guidance, which focuses on three stages: process design, process qualification, and continued process verification. The document then goes into detail about each stage, explaining the goals and key activities of each stage. It provides details on what should be included in process qualification protocols, execution of process qualification, and ongoing activities in continued process verification.
This document discusses validation and the Validation Master Plan (VMP). It provides definitions of validation and qualification, and explains that the VMP outlines the validation strategy, activities, responsibilities, and schedule for a manufacturing organization. The VMP identifies all items, processes, and systems to be validated; defines protocols, acceptance criteria and documentation requirements; and helps management and regulators oversee the validation work. It provides a master plan and map for all validation activities.
This document provides an overview of process validation according to FDA guidance. It defines process validation as collecting data from process design through commercial production to establish that a process is capable of consistently delivering quality products. The guidance outlines a lifecycle approach with three stages: process design, process qualification, and continued process verification. Process design defines the commercial process based on development knowledge. Process qualification evaluates the design and determines if the process is reproducible. Continued process verification ensures the process remains controlled during routine production. Critical quality attributes and critical process parameters are identified, and control strategies are established.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
The document discusses the new approach to process validation according to ICH Q8-Q11 guidelines. It introduces Quality by Design (QbD) principles which emphasize process and product understanding through design space and control strategies. The new approach involves three stages over the product lifecycle: process design, process qualification, and continued process verification. It focuses on collecting data from the beginning of development through commercial production to scientifically prove a consistent quality product.
Presentation Updating the Manufacturing Principles TGA Australia
The document discusses updates to the PIC/S Guide to GMP (PE009). It provides an overview of the processes used by the EMA, PIC/S, and TGA to adopt and implement GMP updates. It outlines some of the key changes between PE009-13 and the previous version, and discusses future revisions including changes expected in PE009-14 regarding premises and equipment, production, complaints and recalls. The speaker emphasizes that GMPs are updated regularly to address risks to patient health and ensure international equivalence, and that manufacturers should follow the TGA's transition plan to adopt the latest requirements.
FDA (invited) Presentation - Specifications and Analytical Method Lifecycle f...Stephan O. Krause, PhD
Stephan O. Krause presented on analytical method lifecycles for accelerated biological product development. He outlined typical and ideal analytical method lifecycles, highlighting opportunities to reduce steps for accelerated programs using analytical platform technology methods. Krause discussed qualification versus verification approaches for these methods, case studies on HPSEC and AUC methods, and a survey on analytical method transfers. He provided an example of revising HPSEC specifications based on manufacturing and clinical experience.
The document summarizes the key changes in the 2011 FDA guidance on process validation from the 1987 guidance. It outlines a three-stage approach to process validation: 1) process design, 2) process qualification, and 3) continued process verification. The 2011 guidance emphasizes process understanding, use of statistical methods, and alignment with product lifecycles. It also revises concepts like worst-case conditions, revalidation, and allows matrix and concurrent validation approaches under certain circumstances.
This document discusses validation, including definitions, purposes, types, and processes. It provides details on:
1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
2. Validation is important for new processes and equipment, changes to existing processes/equipment, and where product testing alone cannot ensure quality. It occurs in three phases: pre-validation qualification, process validation, and validation maintenance.
3. A validation master plan is a comprehensive document that describes validation requirements for a facility and provides a validation plan. It covers qualifications, personnel, schedules, and documentation for the validation process.
PIC/S Guide to GMP PE009-13 - Key changes to Annex 15 - Qualification and val...TGA Australia
The TGA has now legislated version 13 of the PIC/S guide to GMP for medicinal products with a transition period for implementation ending at the end of 2018. Some of the biggest changes in this version were in Annex 15 – Qualification and Validation. This has an impact across all areas in including small to medium sized manufacturers as well as sponsors who need to understand the impact in their supply chain including contract manufacturing and storage and transportation.
This tutorial provides an overview of validation for biotechnological and pharmaceutical processes. It defines validation and describes the three phases: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It explains that the FDA regulates validation through guidelines like 21 CFR Parts 210, 211, 600 and 610. Both equipment and overall manufacturing processes must be validated to consistently produce quality products. Facility design should also consider validation requirements.
The document discusses various aspects of validation in the pharmaceutical industry. It begins with introducing validation and its importance in assuring quality of pharmaceutical products. It then covers topics such as validation planning, documentation, validation master plan, types of validation including process, cleaning and equipment validation. The document also discusses ICH and WHO guidelines for validation. It highlights the need, merits and demerits of validation as well as who performs validation activities. Finally, it provides an overview of prospective, retrospective and concurrent validation approaches.
This document provides an overview of validation concepts and processes. It defines validation as providing documented evidence that a process will consistently produce a product meeting predetermined specifications. The document outlines the basic concepts, types, importance, and scope of validation. It also describes validation team members, protocols, master plans, and summary reports. The advantages of validation include reduced costs and assured quality and safety. Limitations include the availability of competent personnel and cost.
75 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, Ch...Obaid Ali / Roohi B. Obaid
This document summarizes key aspects of pharmaceutical manufacturing process validation according to international guidance documents. It discusses the three stages of process validation: process design, process qualification, and continued process verification. Stage 1 involves understanding the product, process, and sources of variation. Stage 2 requires prerequisites like qualified equipment and validated methods, and involves process execution and documentation. Stage 3 focuses on maintenance and real-time process verification. The document emphasizes applying a risk-based approach and leveraging prior knowledge throughout validation.
Process validation is establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. This presentation discusses process validation, including its definition, scope, objectives, types (prospective, retrospective, concurrent, revalidation), stages, responsibilities of different departments, protocols, sampling procedures, acceptance criteria, and reports. Key aspects of process validation include protocols, sampling plans, specifications, batch execution records, and data analysis to ensure a process is capable of reproducible commercial manufacturing of pharmaceutical products that meet quality standards.
Complete discussion about the Pharmaceutical validation, its types, difference between calibration and validation, validation master & calibration master plan
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
Quality by Design (Qbd) in Product Life Cycle Management (PLCM)Dr. Girish S Sonar
This presentation will cover introduction of QbD, benefits & misconception about QbD. Nowadays, the application of QbD in the PLCM is a widely used in the pharma industry to understand product thoroughly, reduce development and post approval cost and reduce failures. The topic is emphasis on QbD element, QbD stages, Optimization studies, Quality risk management, Risk management tools, Post submission phase and their relation.
Presentation: TGA manufacturing principles update - Adoption of PIC/S Guide t...TGA Australia
TGA is adopting updates to the PIC/S Guide to GMP including PE009-13 and future revisions such as PE009-14. Key points include:
- PE009-13 was adopted on January 1, 2018 with a 12 month transition period for industry to comply.
- Future revisions will address additional chapters and annexes to further clarify requirements.
- TGA plays an active role in updating PIC/S GMP guidance to ensure risks are addressed and GMP keeps pace with innovation.
- Adopting international standards supports TGA's mutual recognition agreements and provides assurance in international markets.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
The document discusses validation in the pharmaceutical industry. It defines validation according to WHO, US FDA, and ICH and explains the need, importance, scope and types of validation. The main types discussed are process validation, cleaning validation, equipment validation, and validation of analytical methods. Documentation for validation includes the validation master plan, validation protocols and reports, and standard operating procedures. Qualification is also discussed as being related to but distinct from validation, involving design, installation, operational and performance qualification of equipment.
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.
This document provides an overview of pharmaceutical validation. It defines validation and discusses the types, stages, scope, and importance of validation. It also covers validation protocols, master plans, and summary reports. The main points are:
- Validation ensures a process consistently produces products meeting specifications.
- Types include prospective, concurrent, retrospective, and revalidation.
- Stages are installation qualification, operational qualification, and performance qualification.
- Validation applies to analytical methods, equipment, facilities, packaging, and manufacturing operations.
- Protocols, master plans, and summary reports provide documentation of validation activities.
Product type- Drug development - Departments of facility- Registration pathwa...Asmaa Khalil
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
Different Export Prices of Medicinal Drugs.pdfAsmaa Khalil
The document discusses different price levels for drugs from factory to public. The EX-Factory price is the cost from the seller's factory. The wholesaler price is between the factory and pharmacies. The public or retail price is what pharmacies charge the public. It also defines CIF, FOB, and CFR pricing terms for exports, with CIF including cost, freight, and insurance, FOB including just cost, and CFR including cost and freight but not insurance. Export prices generally use CIF or FOB, rarely CFR.
The document discusses the new approach to process validation according to ICH Q8-Q11 guidelines. It introduces Quality by Design (QbD) principles which emphasize process and product understanding through design space and control strategies. The new approach involves three stages over the product lifecycle: process design, process qualification, and continued process verification. It focuses on collecting data from the beginning of development through commercial production to scientifically prove a consistent quality product.
Presentation Updating the Manufacturing Principles TGA Australia
The document discusses updates to the PIC/S Guide to GMP (PE009). It provides an overview of the processes used by the EMA, PIC/S, and TGA to adopt and implement GMP updates. It outlines some of the key changes between PE009-13 and the previous version, and discusses future revisions including changes expected in PE009-14 regarding premises and equipment, production, complaints and recalls. The speaker emphasizes that GMPs are updated regularly to address risks to patient health and ensure international equivalence, and that manufacturers should follow the TGA's transition plan to adopt the latest requirements.
FDA (invited) Presentation - Specifications and Analytical Method Lifecycle f...Stephan O. Krause, PhD
Stephan O. Krause presented on analytical method lifecycles for accelerated biological product development. He outlined typical and ideal analytical method lifecycles, highlighting opportunities to reduce steps for accelerated programs using analytical platform technology methods. Krause discussed qualification versus verification approaches for these methods, case studies on HPSEC and AUC methods, and a survey on analytical method transfers. He provided an example of revising HPSEC specifications based on manufacturing and clinical experience.
The document summarizes the key changes in the 2011 FDA guidance on process validation from the 1987 guidance. It outlines a three-stage approach to process validation: 1) process design, 2) process qualification, and 3) continued process verification. The 2011 guidance emphasizes process understanding, use of statistical methods, and alignment with product lifecycles. It also revises concepts like worst-case conditions, revalidation, and allows matrix and concurrent validation approaches under certain circumstances.
This document discusses validation, including definitions, purposes, types, and processes. It provides details on:
1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
2. Validation is important for new processes and equipment, changes to existing processes/equipment, and where product testing alone cannot ensure quality. It occurs in three phases: pre-validation qualification, process validation, and validation maintenance.
3. A validation master plan is a comprehensive document that describes validation requirements for a facility and provides a validation plan. It covers qualifications, personnel, schedules, and documentation for the validation process.
PIC/S Guide to GMP PE009-13 - Key changes to Annex 15 - Qualification and val...TGA Australia
The TGA has now legislated version 13 of the PIC/S guide to GMP for medicinal products with a transition period for implementation ending at the end of 2018. Some of the biggest changes in this version were in Annex 15 – Qualification and Validation. This has an impact across all areas in including small to medium sized manufacturers as well as sponsors who need to understand the impact in their supply chain including contract manufacturing and storage and transportation.
This tutorial provides an overview of validation for biotechnological and pharmaceutical processes. It defines validation and describes the three phases: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It explains that the FDA regulates validation through guidelines like 21 CFR Parts 210, 211, 600 and 610. Both equipment and overall manufacturing processes must be validated to consistently produce quality products. Facility design should also consider validation requirements.
The document discusses various aspects of validation in the pharmaceutical industry. It begins with introducing validation and its importance in assuring quality of pharmaceutical products. It then covers topics such as validation planning, documentation, validation master plan, types of validation including process, cleaning and equipment validation. The document also discusses ICH and WHO guidelines for validation. It highlights the need, merits and demerits of validation as well as who performs validation activities. Finally, it provides an overview of prospective, retrospective and concurrent validation approaches.
This document provides an overview of validation concepts and processes. It defines validation as providing documented evidence that a process will consistently produce a product meeting predetermined specifications. The document outlines the basic concepts, types, importance, and scope of validation. It also describes validation team members, protocols, master plans, and summary reports. The advantages of validation include reduced costs and assured quality and safety. Limitations include the availability of competent personnel and cost.
75 min talk in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. Pharm, Ch...Obaid Ali / Roohi B. Obaid
This document summarizes key aspects of pharmaceutical manufacturing process validation according to international guidance documents. It discusses the three stages of process validation: process design, process qualification, and continued process verification. Stage 1 involves understanding the product, process, and sources of variation. Stage 2 requires prerequisites like qualified equipment and validated methods, and involves process execution and documentation. Stage 3 focuses on maintenance and real-time process verification. The document emphasizes applying a risk-based approach and leveraging prior knowledge throughout validation.
Process validation is establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. This presentation discusses process validation, including its definition, scope, objectives, types (prospective, retrospective, concurrent, revalidation), stages, responsibilities of different departments, protocols, sampling procedures, acceptance criteria, and reports. Key aspects of process validation include protocols, sampling plans, specifications, batch execution records, and data analysis to ensure a process is capable of reproducible commercial manufacturing of pharmaceutical products that meet quality standards.
Complete discussion about the Pharmaceutical validation, its types, difference between calibration and validation, validation master & calibration master plan
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
Quality by Design (Qbd) in Product Life Cycle Management (PLCM)Dr. Girish S Sonar
This presentation will cover introduction of QbD, benefits & misconception about QbD. Nowadays, the application of QbD in the PLCM is a widely used in the pharma industry to understand product thoroughly, reduce development and post approval cost and reduce failures. The topic is emphasis on QbD element, QbD stages, Optimization studies, Quality risk management, Risk management tools, Post submission phase and their relation.
Presentation: TGA manufacturing principles update - Adoption of PIC/S Guide t...TGA Australia
TGA is adopting updates to the PIC/S Guide to GMP including PE009-13 and future revisions such as PE009-14. Key points include:
- PE009-13 was adopted on January 1, 2018 with a 12 month transition period for industry to comply.
- Future revisions will address additional chapters and annexes to further clarify requirements.
- TGA plays an active role in updating PIC/S GMP guidance to ensure risks are addressed and GMP keeps pace with innovation.
- Adopting international standards supports TGA's mutual recognition agreements and provides assurance in international markets.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
The document discusses validation in the pharmaceutical industry. It defines validation according to WHO, US FDA, and ICH and explains the need, importance, scope and types of validation. The main types discussed are process validation, cleaning validation, equipment validation, and validation of analytical methods. Documentation for validation includes the validation master plan, validation protocols and reports, and standard operating procedures. Qualification is also discussed as being related to but distinct from validation, involving design, installation, operational and performance qualification of equipment.
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.
This document provides an overview of pharmaceutical validation. It defines validation and discusses the types, stages, scope, and importance of validation. It also covers validation protocols, master plans, and summary reports. The main points are:
- Validation ensures a process consistently produces products meeting specifications.
- Types include prospective, concurrent, retrospective, and revalidation.
- Stages are installation qualification, operational qualification, and performance qualification.
- Validation applies to analytical methods, equipment, facilities, packaging, and manufacturing operations.
- Protocols, master plans, and summary reports provide documentation of validation activities.
Product type- Drug development - Departments of facility- Registration pathwa...Asmaa Khalil
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
Different Export Prices of Medicinal Drugs.pdfAsmaa Khalil
The document discusses different price levels for drugs from factory to public. The EX-Factory price is the cost from the seller's factory. The wholesaler price is between the factory and pharmacies. The public or retail price is what pharmacies charge the public. It also defines CIF, FOB, and CFR pricing terms for exports, with CIF including cost, freight, and insurance, FOB including just cost, and CFR including cost and freight but not insurance. Export prices generally use CIF or FOB, rarely CFR.
Global medicine regulatory authorities websites.pdfAsmaa Khalil
This document lists regulatory authorities' websites for medicines in various countries and regions. It includes 38 websites for countries in Africa and the Eastern Mediterranean, 21 websites for countries in Europe and European authorities, 19 websites for countries in the Americas, 36 websites for countries in Asia, and 11 websites for countries in Russia and the CIS region. The websites listed are mainly for countries' ministries of health and medicines regulatory authorities.
This document provides an overview of Gulf and European registration pathways for pharmaceutical products. It compares the registration processes and requirements between the Gulf Cooperation Council (GCC) countries and the European Union (EU). Specifically, it outlines the national and centralized registration options in GCC countries and EU, compares Module 1 requirements and chemistry, manufacturing and controls (CMC) data requirements between GCC and EU dossiers. It also provides timelines and performance targets for the different registration procedures in Saudi Food and Drug Authority (SFDA) and the EU.
The document provides tips for improving CVs and developing careers in the pharmaceutical field. It recommends including personal details, education, computer skills, training courses, and checking for spelling errors on CVs. It also lists various career opportunities for pharmacists and free online trainings from global organizations covering medicine, pharmaceutical industry topics, and good manufacturing practices. Contact details are provided for networking and sharing beneficial resources.
This document lists links to various ministries of health and medicine regulatory authority websites around the world, organized by region. It includes over 150 links to websites for countries in Africa, the Eastern Mediterranean, Asia, Europe, and the Americas. The websites provided are for organizations that regulate medicines and pharmaceutical products in their respective countries.
The document lists 17 new molecular entities approved by the FDA in 2022, including drugs to treat insomnia, eczema, hemolytic anemia, myelofibrosis, seizures, prostate cancer, vulvovaginal candidiasis, hypertrophic cardiomyopathy, Helicobacter pylori infection, type 2 diabetes mellitus, plaque psoriasis, polyneuropathy of hereditary transthyretin-mediated amyloidosis, hepatorenal syndrome, elevated intraocular pressure, amyotrophic lateral sclerosis, bile duct cancer, acute myeloid leukemia, non-small cell lung cancer, HIV-1 infection, and as a hyperpolarized contrast agent. Each drug is listed with its active ingredient
To formally attest to a signature on a document, a notary public will sign and stamp the document with their seal after verifying the identity of the signer. For countries that have signed the Hague Convention, only an apostille is needed, which is a certificate attached to the document by the Ministry of Foreign Affairs to authenticate the notary's seal. If the country is not part of the Hague Convention, the document must go through a process of legalization where each country's authorities further authenticate the document so it will be recognized as valid.
How to implement a successful regulatory due diligence.pdfAsmaa Khalil
How to implement a successful regulatory due diligence, in order to grant the DP MA license on a short time frame?, and What are the Formatting requirements for eCTD Publishing?
Introduction about CTD, NeeS & eCTD.pdfAsmaa Khalil
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms for those who already suffer from conditions like depression and anxiety.
The document discusses common conflicts and pains that can lead to delays in the drug registration process from a commercial point of view. It identifies several key challenges, including lacking a project plan, regulatory intelligence, and issues with CMC data for both drug substances and drug products. Specific problems are outlined, such as invalid certificates, missing documentation, and inconsistencies between dossier sections. Recommendations are provided on how to address these challenges to minimize timelines and cut costs in the registration process.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
This document summarizes the different types of marketing authorizations (MAs) in the European Union. There are national MAs granted by individual countries, as well as mutual recognition procedures (MRP), decentralized procedures (DCP), and centralized procedures (CP) which allow approval in multiple EU states. The MRP and DCP rely on one state conducting an initial assessment, while the CP provides a single approval valid across all EU states. Applications must demonstrate a positive benefit-risk assessment based on quality, safety, and efficacy considerations.
This document provides information about career opportunities for pharmacists and how to build a career. It discusses roles in various practice settings like community pharmacies, hospitals, and the pharmaceutical industry. It also mentions roles in government agencies, academia, and research. The document then provides tips for career development like obtaining additional education and skills through online courses from organizations like USP, WHO, and Uppsala Monitoring Centre. It emphasizes the importance of ongoing learning and lists social media and networking platforms like LinkedIn for connecting with others in the field.
This document provides information about career opportunities for pharmacists and how to build a career. It discusses roles in various practice settings like community pharmacy, hospitals, and industry. Industry roles include departments like quality assurance, production, and regulatory affairs. Other career paths include government agencies and academic/research. The document then provides suggestions for education and skills development like online courses from USP, WHO, and Uppsala Monitoring Centre on topics like GMP, pharmacovigilance, and COVID-19. It also recommends connecting on LinkedIn and Facebook for virtual meetings on career planning, entrepreneurship, and digital skills.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
2. 9/29/2021
Stages of PV
History of
PV
New
approach
of CPV
Current PV
guidelines
Validation vs
Qualification
Importance
of
validation
Definitions
of PV
Process
steps to be
validated
Objectives
of PV
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
3. We validate processes & qualify equipment to reduce the variables in the
manufacturing process.
We qualify equipment to ensure that it operates as expected & within known
tolerances.
We calibrate instruments to ensure that the data being collected is accurate.
We validate process to define & verify the proven acceptance ranges that
produce a product that will meet specification.
o The proven acceptance ranges is defined by design of process understanding
experiments prior to verification by process performance verification.
Importance of validation
4. 9/29/2021
Stages of PV
History of
PV
New
approach
of CPV
Current PV
guidelines
Validation vs
Qualification
Importance
of
validation
Process
steps to be
validated
Objectives
of PV
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
5. • The collection & evaluation of data, from the process design stage
through commercial production, which establishes scientific evidence
that a process is capable of consistently delivering quality product.
• Documented evidence which provides a high degree of assurance
that a specific process will consistently result in a product that meets
predetermined specifications and quality characteristics.
• The documented evidence that the process, operated within
established parameters, can perform effectively and reproducibly to
produce a medicinal product meeting its predetermined specifications
and quality attributes.
Definitions of of process validation
6. 9/29/2021
Stages of PV
History of
PV
New
approach
of CPV
Current PV
guidelines
Validation vs
Qualification
Importance
of
validation
Process
steps to be
validated
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
7. To provide the highest assurance that all production batches (unit
doses) will be consistently efficacious as the clinical batch(es).
To reduce risk to safety via the highest assurance of acceptable
and consistent quality of the product and its components.
Objectives of process validation
8. 9/29/2021
Stages of PV
History of
PV
New
approach
of CPV
Current PV
guidelines
Validation vs
Qualification
Importance
of
validation
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
9. • All steps that are generally considered critical (medium & high risk steps)
should be monitored/scrutinized:
by summarizing actual process parameters applied & observations recorded
e.g. sifting stage, wet & dry granulation stages
observations serve as a feedback for future refinement of process parameters
• In addition, where feasible, sampling & testing should be performed
e.g. drying, mixing steps, compression, filling
results measure effectiveness and consistency of the immediate as
well as preceding steps:
e.g. final blend characteristics are mainly shaped by wet/dry
granulation process
Process steps to be validated
10. 9/29/2021
Stages of PV
New
approach
of CPV
Current PV
guidelines
Validation vs
Qualification
Importance
of
validation
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
History of
PV
11. • FDA released “Guideline on General Principles of Process Validation” in 1987.
• This guideline emphasize that process validation is complete with the 3 validation
lots at the commercial scale.
• An alternative approach to this traditional process validation is the continuous
process verification (CPV), known as life-cycle approach which is the essence of
the concept of QbD.
• In Aug 2009, ICH released a guideline Q8R(2) (Step 4) to guide the industry in the
implementation of (QbD) in Section 3.2.P.2 (Pharmaceutical Development) for DPs
as defined in Module 3 of the CTD (ICH guideline M4).
• ICH Q8 - Continuous Process Verification An alternative approach to process
validation in which manufacturing process performance is continuously
monitored & evaluated.
• FDA PV guide - Continued Process Verification Documented evidence that the
process remains in a state of control during commercial manufacture.
History of PV
12. 9/29/2021
Stages of PV
History of
PV
Current PV
guidelines
Validation vs
Qualification
Importance
of
validation
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
13. This guidance incorporated:
• QbD
• Process Analytical Technology (PAT)
• Risk management
• The concept of life cycle approach to PV
New approach of CPV
14. 9/29/2021
Stages of PV
History of
PV
Validation vs
Qualification
Importance
of
validation
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
15. FDA, January 2011 WHO, Annex 3
WHO Technical Report Series, No.
992, 2015
EMA, November 2016
CPV CPV Alternative approaches:
* Traditional approach
* CPV
Process design and Initial
validation (process
qualification- PPQ) are initial
phases of CPV.
Process design and initial
validation (initial process
verification) are initial phases
of CPV.
CPV protocol to be supported
by extensive development
information & lab or pilot
scale data. Executed on each
production batch.
No mention of number of
batches for initial process
performance
qualification/validation
(rather must be justified based
on overall product & process
understanding)
Mentions data on at least
three pilot or production
batches collected as part of
process design.
Number of batches specified
for traditional approach:
* minimum of three
production batches unless
other wise justified.
Current PV guidelines
16. 9/29/2021
Stages of PV
History of
PV
Importance
of
validation
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
17. Validation vs Qualification
Validation Qualification
Validation is establishing a documented
evidence to provide a high degree of
assurance that a specific system,
process or facility will consistently
produce a product meeting its
predetermined specifications & quality
attributes.
Qualification is a process of assurance
that the specific system, premises or
equipment are able to achieve the
predetermined acceptance criteria, to
confirm the attribute that it claimed to
do.
It is documented evidence that a
specific piece of equipment, facility or
system is fit/ready for intended use.
Processes/Procedures (the way we use
things) are validated, e.g. cleaning,
manufacturing process & analytical
methods
Equipment, Instruments & utility systems
are qualified
18. 9/29/2021
Stages of PV
History of
PV
Importance
of
validation
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Life cycle
approach
19. Verification
Distribution
to market
In control
Stage 1 –
Process Design
Facility
Design
Facility &
Equipment
Qualification
Process
Performance
Qualification
(PV)
Stage 3 –
CPV
Life cycle approach
Stage 2 –
Process Qualification
Identification of
process variables
Control strategy
Process
monitoring &
improvement
20. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Stage I PD
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
21. Stages of PV
Stage 1 –
Process Design
(PD)
Process validation comprises three stages that take place over the life cycle of product
• Risk assessment on CPPs & CQAs
• Finalize the control plan
• Finalize batch record
The commercial
process is defined
during this stage based
on knowledge gained
through development
and scale-up activities.
• R&D – ICH Q8 “Identify
quality characteristics,
identify process parameters,
IPC controls, operating range,
acceptable range”
• Define likely CPPs & CQAs
• Develop a control plan “SPx,
target product profile,
determine upper & lower
limits for operating &
acceptable ranges”
Stage 2 –
Process
Qualification (PQ)
Stage 3 –
Continued Process
Verification (CPV)
Sampling
&
testing
During this stage, the process
design is evaluated to determine
if the process is capable of
reproducible commercial
manufacturing. (stage prior to
commercialization or prior to
submitting a registration
application)
• Equipment/Utility/Facility
Qualification (EQ)
• Process Performance Qualification
(PPQ), IPC, release & shelf life
spx, approved validation protocols
& reports with test data &
summary.
• Transfer to operations
• Ongoing assurance is
gained during routine
production that the
process remains in a state
of control. (includes
products that are
commercialized & currently
marketed products with
completed prospective
validation)
• Variation detection
“Understanding Process
Variability”
• Process Signals During
Routine Monitoring
• Ongoing monitoring of some
CPPs & CQAs
• PQRs & APQRs
22. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Definition of QbD
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
23. Development report
A detailed history of how product/process was
developed including source documents for the
control strategy & design space.
Risk assessment report
• A report conducted early in the development
process & updated after completion of
development studies & focused on what needs to
be studies related to the process.
• This document is used to develop design space &
control strategy.
Control strategy
document
This document outlines the control strategy of the
process including a list of any CPPs.
Final manufacturing
process description
document
This document is written based on scale-up
experience which describes the intended process for
process performance qualification (PPQ).
Stage 1 - Process Design
To proceed from stage 1 PC to stage 2 PQ, the following documents must be
completed and approved internally by the company:
24. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
QbD
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
25. QbD is defined as:
“a systematic approach to development that begins with predefined
objectives & emphasizes product & process understanding & process
control, based on sound science & quality risk management.” (ICH Q8)
This is a more systematic approach to development which include, for
example:
• incorporation of prior knowledge,
• results of studies using design of experiments,
• use of quality risk management (ICH Q9),
• and use of knowledge management (ICH Q10) throughout the lifecycle
of the product.
Definition of QbD
26. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
QbD
27. The first crucial step in any formulation development is to understand the
product profile which is called as Quality Target Product Profile (QTPP) in
terms of regulatory.
Once QTPP is identified, formulation scientists need to define what the
“potential” critical qualities attributes of the product (CQAs).
Risk assessment to be carried out to link raw material attributes and process
parameters to CQAs, based on risk assessment control strategy shall be
designed and implemented.
Once control strategy is implemented, there is a need to manage product life
cycle within the design and which becomes part of continual improvement.
QbD
28. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
QbD
29. The key action elements to process design:
1. Develop Quality by Design (QbD) Comprehensive Evaluation
2. Identify Critical Quality Attributes (CQAs)
3. Provide Risk Assessment
4. Execute Product/Process Development
5. Develop Critical Process Parameters (CPPs)
6. Establish Product/Process Design Space
7. Plan Control Strategy
Key elements to process design
30. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
QbD
31. 1. Develop QbD Comprehensive Evaluation:
A company should develop consistent internal evaluation systems & identify material attributes (e.g., API &
critical excipient) & process parameters, to product critical quality attributes (e.g., CQAs).
2. Identify CQAs:
All quality attributes for the product should be evaluated by a company based on a quality target product
profile (QTPP). Potential CQAs should be identified based on an evaluation of the severity of the attribute
in terms of the impact, which is based on clinical experience and in-vitro studies.
3. Provide Risk Assessment:
A company must assess the impact of material, process, & environmental variables on the potential CQAs.
A risk assessment enables the synthesis of important information for the development of control strategy.
This strategy can be revised on an ongoing basis to continue to enhance the company's understanding of its
product and processes.
4. Execute Product/Process Development:
A company should conduct process design experiments on generally accepted scientific principles. Only
those experiments that result in material being used for clinical trials need to be conducted under cGMP
conditions. The subjectivity within a process, such as different API lots, production operators, limitations of
commercial manufacturing equipment, environmental conditions, and measurement systems should be
considered in the product design process. While validating analytical methods is not necessarily required,
analytical methods adopted by the company should be well-defined and provide accurate & consistent
results that can be relied upon.
Steps of process design
32. 5. Develop CPPs:
CPPs should be developed based on the knowledge gained during process development. CPPs should be
consistent with corresponding CQAs.
6. Establish Product/Process Design Space:
While not necessary for each operation, design space is developed by relying on knowledge gained from the
process development studies and input from is a specific defined process that have been demonstrated to
provide quality.
7. Plan Control Strategy:
A control strategy is a planned set of controls, derived from product and process understanding which
assures process performance and product quality. Control strategies should consider material quality,
equipment monitoring and environmental conditions. Control strategies are expected and are needed for
stage 2.
Steps of process design
33. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
QbD
34. Stage 2 - Process Qualification
Protocol for process
performance
qualification (PPQ)
Protocol designing the requirement of the process
performance quality study.
PPQ report
Report summarizing the results and outcome of the
process performance qualification strategy.
To proceed from stage 2 to stage 3: an approved report must be completed and
approved as well:
35. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
QbD
36. Stage 3 - CPV
Process risk
assessment report
A risk assessment is required for all manufacturing
processes. This should be used to determine the
frequency of testing defined in the CPV plan.
CPV plan
Outlines what should be monitored on an outgoing
basis, how the data should be monitored, analyzed,
& reviewed.
CPV report
Summaries of the process monitoring data with
conclusions & recommendations actions.
37. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
QbD
38. Types & stages of PV
Stage I
PD
Stage I
PD
Prospective
validation
Product development/design
• Trial plan, product knowledge &
understanding & control strategy-CPP & CQA.
• Define commercial production process risk
analysis for each separate process step.
• Conducted prior to the distribution of new
product.
Stage Type
Concurrent
validation
• Generally the first 3 production scale batches are
monitored for all process parameters to give
insights on variability & current controls.
• Qualification of utilities & equipment.
• Statistical techniques, sampling plans.
• Process performance qualification, validation
protocol & report.
Ongoing
validated state
Ongoing
maintenance of
validated state
• Examination/ analysis of the past experience
process data & evaluation of the procedure,
composition & equipment remain unchanged.
• Trend analysis performed to determine if the
process parameters adhere to the permissible
range.
Revalidation
• Introduction of new elements in the manufacturing
process e.g. starting material, packaging material,
formulation, change in batch size, process, equipment &
support systems or production & packaging areas
(facility change/technology transfer) which have
impact on product effectiveness or characterization.
Retrospective validation is
no longer considered an
acceptable approach (EU
Regulatory Requirements)
Stage II
PQ
Stage II
PQ
Stage III
CPV
Stage III
CPV
39. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
QbD
40. Success of PV
It Depends on:
Information & knowledge from product & process development.
Controlling the manufacturing process to get specified quality attributes.
Understanding the sources of variation
Detecting the presence & degree of variation.
Understanding the impact of variation on the process & ultimately on product attributes.
Controlling the variation in a manner corresponding to the risk it represents to the process &
product.
41. 9/29/2021
History of
PV
Importance
of
validation
Life cycle
approach
Key elements to PD
Steps of PD
Types &
stages of PV
Stage II PQ Stage III CPV
Success of
PV
Automated
PV lifecycle
Definitions
of PV
Objectives
of PV
Process
steps to be
validated
New
approach
of CPV
Current
PV
guidelines
Current
PV
guidelines
Validation vs
Qualification
Stages of PV
Stage I PD
Definition of QbD
QbD
42. The ValGenesis VLMS automates the validation life cycle by
integrating all the stages of process validation,
from process deign to qualification and
continuous/continued process verification.
Automated process validation lifecycle
43. References
• US FDA Process Validation: General Principles and Practices
https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf
• WHO Technical Report Series, No. 937, 2006 Annex 4 Supplementary guidelines on good manufacturing practices: validation
https://www.who.int/medicines/areas/quality_safety/quality_assurance/SupplementaryGMPValidationTRS937Annex4.pdf
• Annex 3 Guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation
https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex3-TRS992.pdf?ua=1
• WHO Technical Report Series, No. 961, 2011 Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing
https://www.who.int/medicines/areas/quality_safety/quality_assurance/TransferTechnologyPharmaceuticalManufacturingTRS961Annex7.pdf?ua=1
• Guideline on process validation for finished products - information and data to be provided in regulatory submissions 21 November 2016 EMA/CHMP/CVMP/QWP/BWP/70278/2012-
Rev1,Corr.1
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-process-validation-finished-products-information-data-be-provided-regulatory-submissions_en.pdf
• EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, Annex 15: Qualification and Validation
https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-4/2015-10_annex15.pdf
• EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, Annex 15: Qualification and Validation
https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-development-pharmaceutics_en.pdf
• ICH guideline Q8 (R2) on pharmaceutical development
https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-11.pdf