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Katı dozaj şekillerinde proses validasyon
Katı dozaj şekillerinde kaliteyi arttırmaya yönelik çalışmaların güncel yönetmeliklerle değerlendirilmesi anlatışmıştır.
Computer System Validation
This presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
FACTORY ACCEPTANCE TEST
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
Validation of dry_powder_mixer_ .
This document discusses the validation of dry powder mixers, fluid bed dryers, and tray dryers used in pharmaceutical manufacturing. It describes the need for validation to ensure safety, reliability and consistent results. The validation process includes installation qualification to check equipment meets specifications, operational qualification to ensure proper functioning, and performance qualification to verify the equipment achieves expected results. Key parameters monitored include temperature, time, particle size and moisture content. The document provides details on qualification protocols and acceptance criteria to fully validate each piece of equipment.
Cleaning validation
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
V model concept of validation
A system was built according to user requirements and design specifications. A validation plan was created to test the system through functional specifications, process qualification, operational qualification, and installation qualification to validate that the system meets requirements. A validation report was generated following the V-model concept of validation.
Equipment validation of fbd
This document discusses the validation of a fluidized bed dryer. It begins with an introduction to fluidized bed drying and the construction and working of fluidized bed dryers. It then discusses the four stages of validation for equipment: design qualification, installation qualification, operational qualification, and performance qualification. For each stage, it provides details on the specific tests and documentation required for validating a fluidized bed dryer. It emphasizes establishing that the dryer will consistently and reliably perform its intended functions.
STERILE PROCESS OF VALIDATION
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Recommended
Katı dozaj şekillerinde proses validasyon
Katı dozaj şekillerinde kaliteyi arttırmaya yönelik çalışmaların güncel yönetmeliklerle değerlendirilmesi anlatışmıştır.
Computer System Validation
This presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
FACTORY ACCEPTANCE TEST
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
Validation of dry_powder_mixer_ .
This document discusses the validation of dry powder mixers, fluid bed dryers, and tray dryers used in pharmaceutical manufacturing. It describes the need for validation to ensure safety, reliability and consistent results. The validation process includes installation qualification to check equipment meets specifications, operational qualification to ensure proper functioning, and performance qualification to verify the equipment achieves expected results. Key parameters monitored include temperature, time, particle size and moisture content. The document provides details on qualification protocols and acceptance criteria to fully validate each piece of equipment.
Cleaning validation
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
V model concept of validation
A system was built according to user requirements and design specifications. A validation plan was created to test the system through functional specifications, process qualification, operational qualification, and installation qualification to validate that the system meets requirements. A validation report was generated following the V-model concept of validation.
Equipment validation of fbd
This document discusses the validation of a fluidized bed dryer. It begins with an introduction to fluidized bed drying and the construction and working of fluidized bed dryers. It then discusses the four stages of validation for equipment: design qualification, installation qualification, operational qualification, and performance qualification. For each stage, it provides details on the specific tests and documentation required for validating a fluidized bed dryer. It emphasizes establishing that the dryer will consistently and reliably perform its intended functions.
STERILE PROCESS OF VALIDATION
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Pharmaceutical validation
This document discusses pharmaceutical validation and process validation. It begins with an introduction to process validation, describing it as the analysis of data gathered throughout product design and manufacturing to confirm a process can reliably output products to a determined standard. It then covers the documentation of process validation, including validation master plans, protocols, and reports. The rest of the document discusses specific types of process validation and provides examples of validating different pharmaceutical dosage forms and processes.
Annual product reviews
Annual product reviews are conducted annually to assess the quality of drug products and determine if any changes need to be made to product specifications, manufacturing processes, or quality control procedures. The review evaluates analytical data, inspection results, batch failures, complaints, recalls, deviations, stability monitoring results, and corrective actions to verify process consistency and identify quality trends over time. The goal is to continually improve product quality and manufacturing processes.
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring syst...
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring syst...Công ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring systems
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical productsProcess validation
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.
Blend and Content Uniformity : Industry Recommendations for Way Forward
Blend and Content Uniformity : Industry Recommendations for Way ForwardGMP EDUCATION : Not for Profit Organization
This presentation summarizes recommendations from an ISPE working group for assessing blend and content uniformity. The group proposed modifications to address issues with the withdrawn 2002 FDA guidance. Key recommendations include a two-stage blend testing approach using statistical analysis and flexibility in selecting sampling plans, acceptance criteria, and confidence/coverage levels using a risk-based approach.IPQC TEST FOR Qc suppositories
This document discusses quality control tests for suppositories. It describes the different types of suppositories and various tests conducted during quality control, including visual examination, uniformity of weight and texture, melting point determination, breaking strength, dissolution testing, content uniformity, and disintegration testing. The goals of these tests are to ensure suppositories meet specifications for attributes like appearance, consistency, and ability to dissolve or disintegrate properly when administered.
FBD ppt
The document discusses the construction, working, validation process, and qualification protocols for a fluidized bed dryer (FBD) used in pharmaceutical applications. It describes the key components of an FBD and the fluidization drying process. Validation of the FBD involves design, installation, operational, and performance qualifications to ensure proper functioning.
Pharmaceutical process validation (PV)
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
Granulation
This document discusses granulation processes and quality management in the pharmaceutical industry. It covers topics like cGMP, SUPAC guidelines for post-approval changes, validation of granulation equipment and processes, and questionnaires for auditing granulation. The key points are that granulation is a critical manufacturing step that must be validated; SUPAC provides guidance on composition, batch size, site and equipment changes; and validation involves qualifying equipment and demonstrating consistent product quality through processes.
Validation of liquids
The document discusses the validation of liquid oral dosage forms. It defines validation as providing a high degree of assurance that a specific manufacturing process will consistently produce a product meeting predetermined specifications. The validation of liquids includes qualifying equipment and facilities. Critical process parameters for manufacturing oral solutions, suspensions, and emulsions include mixing speed and time, homogenization speed and time, and filtration. Acceptance criteria include product clarity, viscosity, pH, assay, sedimentation volume, resuspension, and particle size. At least three successful validation batches are typically required to validate a new product or process.
Water system validation
The document discusses the validation of water supply systems for pharmaceutical use. It outlines the validation process, which includes design qualification to verify the system design, installation qualification to confirm proper installation, operation qualification to test system functionality under static conditions, and performance qualification to demonstrate consistent performance over time under normal operating conditions. Routine monitoring, maintenance, and change control procedures are also required to ensure continued system operation and water quality as specified.
Qualification of tablet compression machine
The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.
Qualification of high performance liquid chromatography
Qualification of high performance liquid chromatographysrikrupa institute of pharmaceutical analysis
The document provides an overview of the qualification process for high performance liquid chromatography (HPLC) equipment, including design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It describes the objectives and procedures for each qualification step. Key aspects covered include verifying design specifications, proper installation, operational requirements such as precision, accuracy and noise levels, and ongoing performance monitoring. The goal of qualification is to ensure analytical systems are suitable for their intended use and generate reliable results.Equipment validation of tablet compression ( machine)
1) The document outlines the validation process for a tablet compression machine, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
2) The IQ establishes that the machine is installed correctly according to specifications. The OQ tests that the machine operates as intended at different speeds and settings.
3) The PQ evaluates the machine's compression capabilities by producing tablets and testing for characteristics like content uniformity, thickness, hardness, and friability. The validation protocol brings all stages together in a report.
Process Validation of Liquid Orals
The document discusses the validation of liquid oral dosage forms. It defines validation and its objectives, which include ensuring consistency and reproducibility of the manufacturing process. The key stages of validation are described - pre-validation qualification, process validation, and validation maintenance. For liquid orals, the validation would include equipment, raw materials, the manufacturing process, microbiological quality, product specifications, stability, and packaging. Critical process parameters are identified and acceptance criteria defined. The validation report and requirements for revalidation with changes are also summarized.
Validation of equipment copy
The document discusses various aspects of process validation for pharmaceutical products. It defines process validation as a documented program that provides a high degree of assurance a specific process will consistently produce a product meeting its predetermined specifications. It outlines the key stages of process validation including process design, process qualification, and continued process verification. The document also discusses validation of different dosage forms including solids, liquids, semisolids, and parenterals. It covers validation of various processes involved such as mixing, granulation, filling, and inspection. Validation of equipment and facilities is also summarized.
Qualification of Tablet Compression Machine.pptx
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Validation of hvac
This document provides an overview of air handling systems (AHUs) and HVAC qualification for pharmaceutical facilities. It contains sections on introduction, types of clean rooms, principles of clean rooms, HVAC components, regulatory requirements, contamination control, air flow patterns, and HVAC qualification steps including user requirement specification, design qualification, and installation qualification. The objective is to understand the need for pharmaceutical air handling systems and their technical and qualification requirements.
New WHO Guidance on Process Validation
This document provides guidance on validation and qualification principles from the World Health Organization (WHO). It discusses the need for validation and qualification activities to ensure product quality, safety, and efficacy throughout the product lifecycle. Key aspects covered include definitions of validation terms, approaches to validation planning, and documentation requirements such as a validation master plan and protocols.
Gamp5 new
GAMP 5 provides guidance for computerized systems validation. It focuses on risk-based approaches and scalability of efforts based on a system's risk, complexity, and novelty. GAMP 5 also emphasizes leveraging supplier activities and avoiding duplication of efforts. The document provides a framework for life cycle activities from concept to retirement, including planning, specification, development, operation, and retirement of computerized systems.
ISO 9001 2008
Kalite yönetim sistemi ile ilgili sunumlarımda kullandığım sunuyu ilgilenen arkadaşların ilgisine sunmak istedim.
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Pharmaceutical validation
This document discusses pharmaceutical validation and process validation. It begins with an introduction to process validation, describing it as the analysis of data gathered throughout product design and manufacturing to confirm a process can reliably output products to a determined standard. It then covers the documentation of process validation, including validation master plans, protocols, and reports. The rest of the document discusses specific types of process validation and provides examples of validating different pharmaceutical dosage forms and processes.
Annual product reviews
Annual product reviews are conducted annually to assess the quality of drug products and determine if any changes need to be made to product specifications, manufacturing processes, or quality control procedures. The review evaluates analytical data, inspection results, batch failures, complaints, recalls, deviations, stability monitoring results, and corrective actions to verify process consistency and identify quality trends over time. The goal is to continually improve product quality and manufacturing processes.
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring syst...
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring syst...Công ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring systems
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical productsProcess validation
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.
Blend and Content Uniformity : Industry Recommendations for Way Forward
Blend and Content Uniformity : Industry Recommendations for Way ForwardGMP EDUCATION : Not for Profit Organization
This presentation summarizes recommendations from an ISPE working group for assessing blend and content uniformity. The group proposed modifications to address issues with the withdrawn 2002 FDA guidance. Key recommendations include a two-stage blend testing approach using statistical analysis and flexibility in selecting sampling plans, acceptance criteria, and confidence/coverage levels using a risk-based approach.IPQC TEST FOR Qc suppositories
This document discusses quality control tests for suppositories. It describes the different types of suppositories and various tests conducted during quality control, including visual examination, uniformity of weight and texture, melting point determination, breaking strength, dissolution testing, content uniformity, and disintegration testing. The goals of these tests are to ensure suppositories meet specifications for attributes like appearance, consistency, and ability to dissolve or disintegrate properly when administered.
FBD ppt
The document discusses the construction, working, validation process, and qualification protocols for a fluidized bed dryer (FBD) used in pharmaceutical applications. It describes the key components of an FBD and the fluidization drying process. Validation of the FBD involves design, installation, operational, and performance qualifications to ensure proper functioning.
Pharmaceutical process validation (PV)
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
Granulation
This document discusses granulation processes and quality management in the pharmaceutical industry. It covers topics like cGMP, SUPAC guidelines for post-approval changes, validation of granulation equipment and processes, and questionnaires for auditing granulation. The key points are that granulation is a critical manufacturing step that must be validated; SUPAC provides guidance on composition, batch size, site and equipment changes; and validation involves qualifying equipment and demonstrating consistent product quality through processes.
Validation of liquids
The document discusses the validation of liquid oral dosage forms. It defines validation as providing a high degree of assurance that a specific manufacturing process will consistently produce a product meeting predetermined specifications. The validation of liquids includes qualifying equipment and facilities. Critical process parameters for manufacturing oral solutions, suspensions, and emulsions include mixing speed and time, homogenization speed and time, and filtration. Acceptance criteria include product clarity, viscosity, pH, assay, sedimentation volume, resuspension, and particle size. At least three successful validation batches are typically required to validate a new product or process.
Water system validation
The document discusses the validation of water supply systems for pharmaceutical use. It outlines the validation process, which includes design qualification to verify the system design, installation qualification to confirm proper installation, operation qualification to test system functionality under static conditions, and performance qualification to demonstrate consistent performance over time under normal operating conditions. Routine monitoring, maintenance, and change control procedures are also required to ensure continued system operation and water quality as specified.
Qualification of tablet compression machine
The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.
Qualification of high performance liquid chromatography
Qualification of high performance liquid chromatographysrikrupa institute of pharmaceutical analysis
The document provides an overview of the qualification process for high performance liquid chromatography (HPLC) equipment, including design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It describes the objectives and procedures for each qualification step. Key aspects covered include verifying design specifications, proper installation, operational requirements such as precision, accuracy and noise levels, and ongoing performance monitoring. The goal of qualification is to ensure analytical systems are suitable for their intended use and generate reliable results.Equipment validation of tablet compression ( machine)
1) The document outlines the validation process for a tablet compression machine, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
2) The IQ establishes that the machine is installed correctly according to specifications. The OQ tests that the machine operates as intended at different speeds and settings.
3) The PQ evaluates the machine's compression capabilities by producing tablets and testing for characteristics like content uniformity, thickness, hardness, and friability. The validation protocol brings all stages together in a report.
Process Validation of Liquid Orals
The document discusses the validation of liquid oral dosage forms. It defines validation and its objectives, which include ensuring consistency and reproducibility of the manufacturing process. The key stages of validation are described - pre-validation qualification, process validation, and validation maintenance. For liquid orals, the validation would include equipment, raw materials, the manufacturing process, microbiological quality, product specifications, stability, and packaging. Critical process parameters are identified and acceptance criteria defined. The validation report and requirements for revalidation with changes are also summarized.
Validation of equipment copy
The document discusses various aspects of process validation for pharmaceutical products. It defines process validation as a documented program that provides a high degree of assurance a specific process will consistently produce a product meeting its predetermined specifications. It outlines the key stages of process validation including process design, process qualification, and continued process verification. The document also discusses validation of different dosage forms including solids, liquids, semisolids, and parenterals. It covers validation of various processes involved such as mixing, granulation, filling, and inspection. Validation of equipment and facilities is also summarized.
Qualification of Tablet Compression Machine.pptx
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Validation of hvac
This document provides an overview of air handling systems (AHUs) and HVAC qualification for pharmaceutical facilities. It contains sections on introduction, types of clean rooms, principles of clean rooms, HVAC components, regulatory requirements, contamination control, air flow patterns, and HVAC qualification steps including user requirement specification, design qualification, and installation qualification. The objective is to understand the need for pharmaceutical air handling systems and their technical and qualification requirements.
New WHO Guidance on Process Validation
This document provides guidance on validation and qualification principles from the World Health Organization (WHO). It discusses the need for validation and qualification activities to ensure product quality, safety, and efficacy throughout the product lifecycle. Key aspects covered include definitions of validation terms, approaches to validation planning, and documentation requirements such as a validation master plan and protocols.
Gamp5 new
GAMP 5 provides guidance for computerized systems validation. It focuses on risk-based approaches and scalability of efforts based on a system's risk, complexity, and novelty. GAMP 5 also emphasizes leveraging supplier activities and avoiding duplication of efforts. The document provides a framework for life cycle activities from concept to retirement, including planning, specification, development, operation, and retirement of computerized systems.
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Kalite yönetim sistemi ile ilgili sunumlarımda kullandığım sunuyu ilgilenen arkadaşların ilgisine sunmak istedim.
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proses validasyonu I.pdf
- 2. Neden Önemli? Verimlilikte artış Hizmet maliyetlerinde azalma Yeni dozaj formlarının tasarımında daha hızlı ve güvenilir şekilde ilerleme AR-GE alanında ölçek büyütmede kolaylık Ekipman bakımında kolaylık Yüksek otomasyon 2
- 3. İş potansiyeli hakkında çalışan bilincinde artış Otorite gereksinimlerinin karşılanması İşlem ve bitmiş ürün testlerinde azalma İşlem değerlendirmelerinde daha güvenilir, doğru ve hızlı sonuç eldesi İşlem ile ilgili başarısızlıklarda azalma 3
- 4. Genel Tanım İmalat prosesinde istenen özellikte ilaç üretimini sağlayarak, istenmeyen özellikte ürün üretiminin engellenmesi için uyulması gereken kuralların ve limitlerin belirlenmesi, bu şekilde üretimin yapılabilirliğinin ve tekrarlanabilirliğin kanıtlanmasıdır. Proses validasyon kalite sisteminin bir parçasıdır. 4
- 5. FDA’e Göre Proses Validasyon Nedir? Proses validasyonu, prosesin tasarım adımından başlayıp ticari boyut seri imalat aşamasına kadar, bir prosesin devamlı olarak kaliteli bir ürünü oluşturma kapasitesinin bilimsel kanıtını sunan verilerin toplanması ve değerlendirilmesidir. 5
- 6. Avrupa İlaç Ajansı (European Medicines Agency, EMA)’ya Göre Proses Validasyon? Belirlenmiş parametreler dahilinde işleyen bir yöntemin, önceden belirlenen spesifikasyonları ve kalite özelliklerini karşılayan tıbbi bir ürüne dönüşebilmesi amacıyla etkin ve tekrarlanabilir olarak uygulanabilirliğinin dökümante edilerek sunulan kanıtıdır. 6
- 7. PROSES KONTROLLERİ AMAÇ: Ürünün istenen nitelikte olduğunun gösterilmesidir 7 Hammade kontrolleri İn-proses kontroller Final ürün spesifikasyonları
- 8. Proses Analitik Teknolojisi Nihai ürünün istenilen özellikte olması için kullanılacak her maddenin, ürünün ve işlemlerin zamanında değerlendirilmesidir. Kalite sağlanamadığında anında müdahale edilmesini temin etmektedir. Ruhsat dosyalarına uyum nedeniyle innovasyonun sağlanamadığı durumları engellemektedir. 8
- 9. Ürün Yaşam Döngüsü (Drug Product Life Cycle) Ürünün AR-GE laboratuvarında başlayan geliştirme sürecinden itibaren pazara sunulup ticarileştirilerek geniş kitlelerce kullanılmasına kadar devam eden süreçteki tüm fazlara denir. FDA’ye göre validasyon gerçekte üretim aşamasından çok AR-GE’nin bir parçasıdır. İstenen ürün spesifikasyonları bu aşamada belirlenmektedir. 9
- 10. Üretim prosesinin kontrol edilebilirliği ve tek düze üretimin mümkün olması da AR-GE aşamasında prosesin karmaşıklığının azaltılması ile sağlanabilir. Kullanılan maddelerin stabil olduğu koşullar iyice araştırılmalıdır. AR-GE boyutunda ve gerçek üretim serilerinde elde edilen verilerle geniş ve kapsamlı bir kalite sistemi oluşturulmalıdır. 10
- 11. Validasyon Master Planı 1.Planın amaçları 2.Planın kapsamı 3.Validasyonun kapsamı 4. Sorumluluklar 5.Proses ve tesis tanımları 11 6.Valide edilecek sistemlerin belirlenmesi 7. Genel kabul kriterleri 8.Validasyon takvimi 9. Personel ve donanımları 10.Destekleyici programlar
- 12. Proses Validasyonun Kapsamı Deneysel Veriler 12 Geçmiş Dataların Analizi
- 13. FDA’e göre Proses Validasyonun Aşamaları: 13 1 • Proses Dizaynı 2 • Proses Kalifikasyonu 3 • Prosesin Doğruluğunun ve Uygunluğunun Denetlenmesi
- 14. EMA’ya göre Proses Validasyon Yaklaşımları: 14 1 •Geleneksel Proses Validasyonu 2 •Sürekli Proses Doğrulaması 3 •Hibrit Yaklaşım