Tuesday, January 2, 2018
Ethylene Oxide Sterilization Validations
Ethylene Oxide sterilization is well known in the industry and is accepted as a sterilant by the FDA. It is one of the most popular ways of sterilizing medical devices. It is a great form of sterilization for medical devices that are heat sensitive or sensitive to radiation- such as polymers and plastics that can melt, become brittle or deteriorate. http://bit.ly/fuza5C Nelson Labs provides the EO validation testing. www.nelsonlabs.com.
Integrity Testing of Filters Made Simple
If you are considering integrity testing your process membrane filters or you are using an electronic device and want to understand more about what happens in an integrity test our simple video can unravel some of the mysteries associated with this activity. It also demonstrates a simple low cost method of testing that does not required spending thousands of Euros on complicated electronic equipment.
Performing Filter Validations
Filter validation is a technique that is easy to do, but is often overlooked in dissolution method development and validation. More information at http://ift.tt/2CcUXEw
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
Click here for more Information http://ift.tt/2CD8O7X Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements Presented By: Roger Cowan The session will review different filtration media and will discuss in detail the construction characteristics and properties of each. You will get a detailed description of a typical pharmaceutical sterile filtration system with its individual components, including a discussion on engineering schematics. More Videos: - http://www.youtube.com/user/audioeducator2 You can also connect with us on Twitter, Facebook, Google+ and LinkedIn and get the most updated news and views, expert advice and tips to help resolve your coding, billing & compliance dilemmas quickly and accurately. Connect with us on Twitter: - https://twitter.com/audioeducator Facebook: - http://ift.tt/2lzPCk2 LinkedIn: - http://ift.tt/2qaJ2oX Google+: - http://ift.tt/2lzPGAi
Managing Human Factors in Reprocessing of Reusable Devices- Validation Considerations
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge and recommendations about how to manage the human factors in processing of reusable medical devices. Participants will learn: • Standards that govern medical device reprocessing, which include cleaning, disinfection and sterilization validations - Specifically, the new standards associated with human factors - Updates from the AAMI/FDA Round Table Discussion • Challenges inherent in device design for human factors • Considerations for cleaning and sterilization validations relevant to the practices of healthcare facilities • New recommendations for manufacturers, Instructions for Use (IFU) documents, etc. • Review of the manufacturer's responsibilities and considerations
Aseptic Gowning for the Cleanroom
One of the primary safeguards that life science companies use to help prevent contamination in cleanroom operations is Gowning. Gowning is basically putting on clothing -- in this case layers of specially designed garments, covers, masks and gloves -- that isolates your body from the clean room environment. Gowning is more involved than just slipping on a coverall and going to work. Gowning is itself a process, with carefully sequenced steps to ensure that your body is fully covered, and that the protective garb remains free of contamination. In this video, we'll demonstrate the top-down approach for both general and aseptic gowning. Practice using our free Sterile Gowning Game: http://ift.tt/2DKYNVK
Eyecon: Filling Prescriptions in Validation Mode
This video steps the viewer through the process of filling a prescription in validation mode on the Eyecon, thus ensuring the right quantity of the right drug are being dispensed to the right patient.
HEPA filter test demonstration - DOP test
A basic overview of installed HEPA filter leakage testing for ISO14644-3 compliance with a Photometer. This video shows a laskin nozzle Aerosol Generator, PIP (positive injection pump), sparge pipes for aerosol mixing, and the DOP touch Photometer for measuing the upstream challenge and downstream %penetration.
Monday, January 1, 2018
Understanding Steam Sterilization
Meeting the parameters of time, temperature and steam under pressure, steam sterilization is the most effective and efficient sterilization method in dentistry. Understand how to maintain your sterilizer; use the appropriate accessories; record sterilization parameters and what to look for during the ideal sterilization cycle. Don't Risk It! Direct questions to 1-8558-STERILE (Toll-Free) 8am-5pm M-F MST. Crosstex International, Inc. Video Disclaimer This video is owned by the sole property of Crosstex International, Inc. ("Crosstex") and is to be used solely for internal informational purposes. Any copying, distribution, posting or editing of this video production in any format, or any unauthorized or improper use of this video, is strictly forbidden. The information presented in this video is based on current information at the time of production. Crosstex makes no warranty or guarantee concerning the accuracy or reliability of the content of this video. For technical and regulatory guidance, please refer to applicable instructions for use and product labels with respect to any product or process described in this video and current official versions of applicable state, federal or other governmental or regulatory rules, laws, standards, policies, protocols and recommended best practices. Content is subject to change at any time. ©2014 Crosstex International, Inc. All rights reserved.
steam sterilization, how it all works
Essentials of steam sterilization including topics such as sterilant, mode of destruction, biological Indicators, sterilizer anatomy and much more.
Validation of Analytical Methods
Analytical methods plays a vital role in new drug development, Preformulation and formulation studies, stability studies and quality control testing.
Risk Based Validation of Laboratory Systems Recording 02092012
I created this video with the YouTube Video Editor (http://www.youtube.com/editor)
Webinar: Filter Integrity Testing Best Practices
Sterile filtration is commonly employed for microbial removal and plays a pivotal role in assuring final product sterility. Where sterility will be claimed, regulatory agencies worldwide require that the sterilizing-grade filter(s) be integrity tested to ensure filter performance is verified prior to and after filter use. Therefore, successful filter integrity tests are a critical link between your filter validation and current processing. Please join Randy Wilkins, Technical Consulting Team Manager at Merck Millipore, for this webinar highlighting best practices and key considerations for performing filter integrity tests. After attending this online event you will have a better understanding of how to design a robust integrity test operation in your own facility. Get Connected! Join EMD Millipore on your favorite social media outlet for the latest updates, news, products, innovations, and contests! Visit us at: http://ift.tt/1b2oJXL Join us on LinkedIn: http://ift.tt/2Cv6MJu Join the community on twitter: https://twitter.com/milliporesigma Do not forget to subscribe to have better access to our videos!
WFI and Pure Steam Systems - Design and Requirements
Design and Requirements Considerations for Critical Ut Learn more about our water purification equipment by visiting http://ift.tt/2Cq4KKH.
Present and Future Changes to Packaging Industry Standards
Packaging standards continue to develop and evolve a decade after the most recent version of ISO 11607:2006 Packaging for Terminally Sterilized Medical Devices. This presentation will provide an overview of the changes that are currently being discussed as well as working items that are under consideration that could affect the standards tomorrow. It will touch on the changes to the pharmaceutical packaging industry with regards to USP Guidance chapter 1207 PACKAGE INTEGRITY EVALUATION—STERILE PRODUCTS and Medical Device ASTM method work item developments and updates.
Packaging Test Methods for Validation of Sterile Barrier Materials
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge to make decisions regarding which tests should be used to validate their sterile barrier system. By focusing on specific tests as outline in ISO11607, each individual will have the opportunity to view actual test methods, determine appropriate test samples and identify pros and cons to each method. Some of the methods viewed will consist of Bubble Emission ( ASTM F2096), Microbial Ranking (ASTM F1608), Burst Testing (ASTM F1140), Seal Strength Testing (ASTM F88), and Dye Migration (ASTM F1929).
Medical Device Packaging Validations
Packaging Validations demonstrate the strength, integrity, and microbial barrier properties for porous and non-porous packages. These validations are required by FDA/ISO regulations before products can be sold. Nelson Labs has a streamlined validation process that meets these requirements and complies with the ISO 11607 "Packaging for terminally sterilized medical devices" standard.
Developing your Packaging Validation Plan
This webinar will provide an overview of the medical device packaging process from conception to testing by examining three critical elements of any medical device package validation plan: 1. Answering the question, Is it necessary to have a documented validation plan before testing begins? This includes touching on prototype design, raw materials, and product interactions with packaging. 2. Review of regulatory requirements for a documented validation plan, and key points to consider when designing, manufacturing, sterilizing, and testing your packaging validation plan. We will also explore the protocol and define what worst case means. 3. Look at possible test methods for validating your packaging, and discuss what would require a re-validation or at the very least documented justification. This webinar is designed for individuals with minimal experience in the medical device market, who are unsure where to begin the medical device packaging process. Participants are encouraged to familiarize themselves with ISO 11607 parts 1 and 2 along with TIR 22.
Ethylene Oxide Sterilization Validation
This webinar is designed to acquaint those in the medical device community with the appropriate ways to develop, optimize, and validate an ethylene oxide sterilization process. The properties and hazards associated with ethylene oxide and the process required to successfully validate a medical device will also be discussed. The validation methods used are outlined in ANSI/AAMI/ISO 11135-1:2007. Some of the related testing includes comparative resistance, bioburden resistance, bioburden enumeration, sterility testing, sterilant gas residues, and temperature/humidity distribution studies. In addition, the batch release method will be outlined. This process allows the manufacturer to sterilize a single lot of product for use in clinical trials or animal studies where large numbers of samples are not available. This provides a rapid and cost effective way to provide sterile product without undergoing the full validation process.
Analytical method validation (Hindi/Urdu)
Regulatory aspects and importance of analytical method validation according to ICH Q2. the pharmaceutical industry needs quality control and quality assurance before release of a medicine for market. pharmaceutical regulatory affairs department is responsible for submission of validation data of analytical method to regulatory bodies for approval before market authorization
Considerations for Cleaning Validation using Automated Washing Systems
What is cleaning validation and where does it fall in the global Life Cycle Validation scheme? How can an automated washing system be validated? This presentation provides insights that may help to respond to these questions. The Life Cycle Approach is a good way to standardize a company’s manufacturing and cleaning processes. The 2011 FDA Guidance document entitled: ‘’Process Validation: General Principles and Practices’’ describes process validation activities into 3 stages; Process Design, Process Qualification and Continued Process Verification. Join us to learn more about these three stages.
Concepts in Cleaning and Disinfection of Controlled Environments / BioForum
Presenter: Renee Morley, Account Manager, Life Science Division for Steris Corporation This webinar will cover the topic of "designing and implementing an effective cleaning and disinfection program," and will bring clarity to the cleaning and disinfection process by covering industry trends, regulatory expectations, and essential elements needed to keep the cleanroom in control. You will learn how to choose and apply cleaners and disinfectants properly depending on the surface, environment and product, which will reduce labor costs and commodity usage. This will include sanitization of a Class 100/10,000 pharmaceutical cleanroom, proper equipment cleaning/disinfection procedures, and validation of disinfectant performance and application. In the end, you will be able to develop validation protocols and a proper cleaning and disinfection program to suit the needs of your company.
Principles Risk Based Process Safety applied to ICH-Q9 "Risk Assessment"
Protecting people’s lives by reducing incidents drastically. Website: http://ift.tt/2DMEwPD Youtube channel: https://www.youtube.com/channel/UCsrjy36NHLKv6ShF30RwLjg Brantford, Ontario: http://ift.tt/2EtMb6l More information about process safety management: http://ift.tt/2DLCsak I have worked with major companies in the pharmaceutical, chemical, food and manufacturing industries. Process Safety Management: I have helped organizations to implement and coordinate elements of the process safety management program to prevent outcomes such as fires, explosions or releases to protect the environment and public safety. Health and Safety I have helped companies to develop and implement health and safety programs and strategies to achieve legal compliance and incident reduction locally and internationally. Safety Engineering. I have helped operations to reach safety compliance in various stages of production, starts up operations, and equipment acquisition to comply with safety regulations, codes and standards to prevent the incident and protect employees. Call me today 613-464-0562 to help you to identify all possible hazards of your operations. You can also check PHARMA-CHEMICALSAFETY pages at: Youtube: https://www.youtube.com/channel/UCsrjy36NHLKv6ShF30RwLjg Facebook: http://ift.tt/2EyQI7I Twitter: https://www.twitter.com/Pharmachemical1 LinkedIn: http://ift.tt/2DLU4mr Google+: http://ift.tt/2EwfBRt
Pharmaceutical Qualification vesves Validation
The presentation gives details of qualification and Validation required as per GMP. It covers details on Validation Master Plan, DQ,IQ,OQ,PQ, Validation . The best easy way to describe the Pharmaceutical Qualification vesves Validation. You will clearly understand the Process Validation, cleaning validation with . Validation department responsible for equipment qualification as per schedule.qualification is very important part of pharma industry. IQ OQ PQ is the new product introduction procedure used at Elite Plastics. Bruce Wold, Engineering Manager at Elite Plastics, walks you through the process in .
Validation and Requalification of Steam Sterilizers | STERIS Life Sciences
View STERIS Life Sciences Webinar on Validation and Requalification of Steam Sterilizers. Learn more about our products by visiting http://ift.tt/2Cp3BDR
Airflow Visualization Test - Cleanroom
A sample video of Airflow Visuzalization Test from various projects in cleanrooms
How to create a cleanroom smoke Visualisation
CleanroomsAustralia.com.au cleanrooms make visualisation in a class seven and class eight cleanrooms Suite built to ISO 14644.1 standards which shows smoke visualisation of laminar airflow,mixed airflow, differential pressures across doors, exhaust air entrainment, large particulars entrainment from low-level. Hello and welcome to Cleanrooms Australia presentation of "how to create a smoke visualisation in a cleanroom" we would like to take this opportunity to show you around and ISO 14644 class seven and class eight mixed flow cleanroom facility. There is some laminar flow in this cleanroom, below the HEPA filter, that is to be located directly above a production area, once the machinery and equipment is in place, you may have noticed that we have turned down the lighting from 800 Lux to create shadows on the walls to give some contrast against the crisp white smoke, at a high density. With all these things taken into consideration, you can get some very good visualisation of the mixing of the air, the laminar flow and the mixed flow differential pressures, across the boundaries, and I surely going to do this on one or two occasions, to prove your conditions of mixed air flow or laminar air flow, we take the opportunity to do this, during the commissioning stage while technicians are still able to enter the cleanroom without gowning, as the smoke is likely to do contaminate the cleanroom facility, if you don't get the shot in one or two takes, if it's a mixed flow area you're likely to get the smoke disseminating across the cleanroom and you won't be able to get a clear shot very well. The idea here is that you wait for the recovery of the room once the cleanroom has recovered you take a shot. It is also important to use a smoke with large enough particle size to get caught in the primary filters as not to affect the secondary or terminal HEPA filters. The density of the smoke is very important as you can see here with a high airflow across the boundary it somewhat hard to see a flow of air although you can still identify it because of the high density of smoke within the airstream. Thank you for your time and I hope that helped you
FDA Regulation of Medical Device Software (Part 2 of 3)
(Part 2 of 3) Regulation of medical device software.
FDA Regulation of Medical Devices (Part 1 of 3)
(Part 1 of 3) General overview of medical device regulation.
Process Validation for Medical Device Manufacturers
This Video provides regulatory/quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://ift.tt/XYKyrj Email: support@globalcompliancepanel.com Help us caption & translate this video! http://ift.tt/2CoIp0T
IQ OQ PQ - 3 Pillars of Validation
Please join us for a presentation by Validation expert, Suzanne Butch. Suzanne will be reviewing the 3 pillars for maintaining a validated state. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Suzanne H. Butch, MA, MLS(ASCP)SBBCM, DLMCM, CQA(ASQ) Michigan Medicine, Department of Pathology Suzanne H. Butch, received her Bachelors in Medical Technology from the University of Michigan and has a Specialist in Blood Bank certification. She serves in numerous positions of leadership with AABB, Michigan Association of Blood Banks, ICCBBA, American Society for Clinical Laboratory Science, CLSI, and more. Her extensive history of publications, invited lectures, and workshops has made her a sought-after expert in her field.
Process Validation Principles and Protocols for Medical Devices
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit. Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes. This Video shows the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://ift.tt/XYKyrj Email: support@globalcompliancepanel.com Help us caption & translate this video! http://ift.tt/2A0CIQv
Lifecycle Approach to API Process Validation
The goal of API process validation is to ensure the reliable production of high-quality active pharmaceutical ingredients from development through commercialization. The product lifecycle approach established in FDA's 2011 Process Validation Guidance requires different validation activities during the process design and process qualification stages, as well as continued process verification throughout the life of the commercial process. The process validation needs for pre-qualification activities and ongoing process verification can be daunting, especially for small and medium-size pharmaceutical companies. In this webinar, experts on API process validation outline the key requirements for development of a phase appropriate manufacturing plan including regulatory requirements, data collection, specification development, critical process parameters, sampling plans, and analytical method validation. Key Learning Objectives: * Understand the regulatory expectations at each clinical phase. * Determine the key validation aspects of API manufacturing including critical process parameters. * Identify analytical and stability needs as the API advances in the clinic. Moderator: Rita Peters Editorial Director Pharmaceutical Technology Speakers: Paul Wrezel, Ph.D. Director of Analytical Method Development Regis Technologies Bikash Chatterjee President and Chief Technology Officer Pharmatech Associates Inc. Paul L. Pluta, PhD Editor-in-Chief Journal of GXP Compliance and Journal of Validation Technology
Webinar: Modern Process Validation
The objective of the webinar on modern process validation is to review recent regulatory guidance on process validation and to compare and contrast FDA and EMA approaches.
Validation of Methods by Dr. Robert Wever - part 3 of 3
Presentation on validation of methods and instruments in Laboratories according to ISO15189 by Dr. Robert Wever. For more information send your email to: robert_wever@yahoo.com
Validation of Methods by Dr. Robert Wever - part 2 of 3
Presentation on validation of methods and instruments in Laboratories according to ISO15189 by Dr. Robert Wever. For more information send your email to: robert_wever@yahoo.com
Validation of Methods by Dr. Robert Wever - part 1 of 3
Presentation on validation of methods and instruments in Laboratories according to ISO15189 by Dr. Robert Wever. For more information send your email to: robert_wever@yahoo.com
Analytical method validation
pharmaceutical quality control in the laboratories of pharmaceutical industry, required validated analytical method as per requirement of the drug regulatory affair bodies in their region to fulfill the pharmaceutical regulatory affairs requirements to provide quality pharmaceutical products for general public use.
Qc Validation of analytical method .mp4
Qc Validation of analytical method on EXCEL 2007 FOBCU 5th year students Play it on 720 p (HD)
Cleaning Validation Techniques
International Products Corporation conducted a webinar to discuss "Cleaning Validation Techniques". The 30 minute webinar reviews a summary of quantitative and qualitative validation cleaning techniques for both FDA and non-FDA customers. It is followed by questions and answers submitted during the live telecast. International Products Corporation (IPC) a manufacturing company, located in Burlington, NJ, USA. IPC produces and markets two lines of specialty chemical products: precision cleaners, and temporary assembly lubricants. The company serves an international market with customers in the commercial, industrial, government, and academic sectors.
Equipment Validation, Tracking, Calibration, and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The video include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. However, there are ways to validate equipment already in use! For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://ift.tt/XYKyrj Email: support@globalcompliancepanel.com Help us caption & translate this video! http://ift.tt/2A0BnZU
Cleaning Validation Sampling Using Swabs and TOC Analysis
For years the pharmaceutical industry has dealt with challenges associated with swabs and swab sampling. This video from GE Analytical Instruments highlights some key elements that can improve your cleaning validation program and will help you re-think the approach when using swabs for TOC analysis. Learn more at http://ift.tt/2Cmpi7A.
Novel Analytical Methods to Verify Cleaning Process
The manufacturing suite used for pharmaceutical formulation is often not dedicated to one drug only. Manufacturers must be very careful during the switchover process to ensure that the active pharmaceutical ingredient (API) is completely flushed before moving on to the next formulation. Using charged aerosol detection with HPLC allows us to see every non-volatile that might be left behind. Chromatograms with individual peaks represent API residues in the tank and the peaks indicate concentration. For more information: http://chrom.ms/67ZFF6b
Cleaning Validation: Solubility is Important - but not a Solution
Solubility has been the most common objection for the use of Total Organic Carbon analysis for cleaning validation or verification studies for years because of the traditional, product-specific focus that is built into existing cleaning programs. This video shows how GE Analytical Instruments is are helping companies move on from solubility when it comes to cleaning validation.
Designing An Effective Cleaning Validation : Audio Educator
Click here for more Information:http://ift.tt/2q8BJhz Designing An Effective Cleaning Validation For Reusable Medical Devices In Today's Regulatory Environment Presented By: Dr. David Lim, Ph.D., RAC, ASQ-CQA Know the Best Practices for Documentation of Medical Necessity, Critical Care and Other Timed Services! More Videos: - http://www.youtube.com/user/audioeducator2 You can also connect with us on Twitter, Facebook, Google+ and LinkedIn and get the most updated news and views, expert advice and tips to help resolve your coding, billing & compliance dilemmas quickly and accurately. Connect with us on Twitter: - https://twitter.com/audioeducator Facebook: - http://ift.tt/2lzPCk2 LinkedIn: - http://ift.tt/2qaJ2oX Google+: - http://ift.tt/2lzPGAi
Post-Validation Change Control and Maintaing the Validated State
"You need to be able to control changes just as much, with as much discipline and robustness as you did the original validation," Joe Zec says during a presentation from IVT's 11th Annual Change Control. Quoting FDA's General Principles of Software Validation and Process Validation Guidance, Zec enforces the regulators' perspective on change control for a process already in the validated state. "[I]f you're going to maintain this validated state of a process, or a piece of software, or an equipment full change control must remain in effect until retirement..." Through impact analysis, Zec explained, is how a change control process will ensure all applicable elements of a system will update. On behalf of every change, professionals will need to decide whether software and data, hardware, system documentation, user documentation, training, or procedural documentation is affected. "After a system is in a validated state, if any of these elements are allowed to go into an unvalidated state, the whole system goes into an unvalidated state. You need to keep every single one in a validated state via maintenance through change control."
Writing Validation Requests and Validation Plans
At IVT's 4th Annual Validation Week EU, Paul Pluta, Ph.D., explains the process of connecting Stage 1 and Stage 2 of process validation through properly written and well formed validation requests and validation plans. Dr. Pluta discusses the role of R&D in the document's development and demonstrates utilizing these documents for FDA compliance. Comprehensive outlines for both documents are examined.
FDA 21 CFR Part 11 Webinar
Learn how pharmaceutical and medical device manufacturers can comply with the FDAs 21 CFR Part 11 regulations. NiceLabel will explain what is needed to comply with regulations pertaining to electronic records, electronic signatures, and audit trails. NiceLabel's Control Center Enterprise is the perfect software for FDA regulated companies that need label lifecycle management. Global organizations can consolidate their printing from each region and centralize on a single NiceLabel platform.
Introduction to Process Validation
Course Description: This preparatory course provides a hands-on review of manufacturing process validation for medical devices. It lays out the key principles of process validation, including regulatory requirements. The basic statistical considerations for process validation are clearly illustrated in an example. This course covers the following topics: What is process validation? What is verification? When should process validation take place in lieu of verification? Regulatory expectations The concept of “variation” The concept of “process capability” Process inputs General requirements for process validation The three phases of process validation European regulatory requirements for process validation US regulatory requirements for process validation Planning and outputs related to process validation Contribution of risk management to process validation At the end of this course there is a brief slideshow of warning letters from the US FDA addressing findings related to process validation. Learn more at: http://ift.tt/2A0zQTE
Analyzing the FDA Process Validation Guidance
The US Food and Drug Administration's "Process Validation: General Principles and Practices" is now over three years old. Thus, it is shocking how many pharmaceutical and medical device manufacturers have not implemented the approach suggested in this guidance. In this presentation, Paul Pluta, Ph.D., analyzed and clarified the FDA process validation recommendations.
Process Validation
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process ( such as manufacture of pharmaceutical dosage forms) will consistently produce a product meeting its predetermined specifications and quality characteristics. THE MAIN REASONS FOR PROCESS VALIDATION ARE: 1. QUALITY ASSURANCE: Quality cannot be assured by daily quality control testing because of the limitations of statistical samples and the limited facilities of finished product testing. Validation checks the accuracy and reliability of a system or a process to meet the predetermined criteria. A successful validation provides high degree of assurance that a consistent level of quality is maintained in each unit of the finished product from one batch to another batch. 2. ECONOMICS: Due to successful validation, there is a decrease in the sampling and testing procedures and there are less number of product rejections and retesting. This lead to cost-saving benefits. 3. COMPLIANCE: For compliance to current good manufacturing practices CGMPs, validation is essential. ELEMENTS OF VALIDATION: Qualification is prior required condition for validation. The qualification includes the following steps: 1. Design Qualification (DQ) In this qualification, compliance of design with GMP should be demonstrated. The principles of design should be such as to achieve the objectives of GMP with regard to equipment. Mechanical drawings and design features provided by the manufacturer of the equipment should be examined. 2. Installation Qualification (IQ) Installation qualification should be carried out on new or modified facilities, systems and equipment. 3. Operational Qualification (OQ) Operational qualification should follow IQ, OQ should include the: Tests developed from the knowledge of the processes systems and equipment. 4. Performance Qualification (PQ): After IQ and OQ have been completed, the next qualification that should be completed is PQ. PQ should include the following: Tests using production materials, substitutes or simulated product. These can be developed from the knowledge of the process and facilities, systems or equipment. Before any batch from the process is commercially distributed to consumers,a manufacturer should have gained a high degree of assurance in the performance of the manufacturing process such that it will consistently produce APIs and drug products meeting those attributes relating to identity, strength, quality, purity, and potency.The assurance should be obtained from objective information and data from laboratory-,or commercial scale studies. TYPES OF PROCESS VALIDATION 1 PROSPECTIVE VALIDATION: This type of validation is performed before production, during a product’s development stage. A risk analysis is performed to assess the production process by breaking it down into separate steps. These are individually evaluated and based on past experience, the likelihood of each one leading to critical situations is determined. 2 CONCURRENT VALIDATION:This approach involves monitoring of critical processing steps and end product testing of current production, to show that the manufacturing process is in a state of control. You should monitor the first three batches produced on a production-scale as closely as possible. 3 RETROSPECTIVE VALIDATION Retrospective validation is used for facilities, processes, and process controls in operation that have not undergone a formally documented validation process. Validation of these facilities, processes, and process controls is possible using historical data to provide the necessary documentary evidence that the process is doing what it is believed to do. Therefore, this type of validation is only acceptable for well-established processes and will be inappropriate where there have been recent changes in the composition of product, operating processes, or equipment. Retrospective validation should not be considered a quality assurance measure, rather it should be performed only in certain circumstances,like when you’re introducing validation requirements for the first time. It is more useful for establishing priorities for validation, so avoid this technique for new products or processes. 4. REVALIDATION: Revalidation is essential for ensuring that any changes made to the process or its environment have not resulted in adverse effects on product quality or process characteristics.Conditions that require revalidation studies are: 1.Changes in Starting Materials 2.Changes in Packaging Material 3.Changes in Process 4.Changes in Equipment 5.Changes in Support System or Production Area
Understanding the Three Stages of Process Validation
While most professionals know there are three stages of the process validation lifecycle, many are unaware of the activities dictated by each stage. As part of IVT's pre-Validation Week webinar, Paul Pluta, Ph.D., explained the prescribed endeavors of Stage 1, Stage 2, and Stage 3 of process validation as recommended by the US Food and Drug Administration.
HVAC and GMP Enviorment Control for Pharmaceutical clean rooms
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective. For more info http://ift.tt/2DLYnON
Cleaning Validation Sampling Using Swabs and TOC Analysis
For years the pharmaceutical industry has dealt with challenges associated with swabs and swab sampling. This video from GE Analytical Instruments highlights some key elements that can improve your cleaning validation program and will help you re-think the approach when using swabs for TOC analysis. Learn more at http://ift.tt/2Cmpi7A.
Cleaning Validation SOPs
During a session at IVT's 17th Annual Validation Week, Dawn Tavalsky explained the proper execution of standard operating procedures (SOPs) for cleaning validation. Tavalsky discussed the training operators, visual inspection, and eye exams.
Pharmaceutical Qualification & Validation
The best easy way to describe the Pharmaceutical Qualification & Validation. You will clearly understand the Process Validation, cleaning validation with examples and calculation, Area Validation, water system validation, Personnel qualification, Equipment qualification with day in day out examples.
Qualification and Validation
The presentation gives details of qualification and Validation required as per GMP. It covers details on Validation Master Plan, DQ,IQ,OQ,PQ, Validation Protocols and what is expected in Validation Reports
Pharmaceutical Water: System Design, Operation, and Validation
This book is Good for professionals dealing with water treatment system.
This book covers the following aspects of water treatment system.
A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries―used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.
Drawing on the author’s extensive field experience with more than 400 pharmaceutical and related water purification systems, the text’s numerous case studies illuminate the best and worst of water system design and operation.
This book covers the following aspects of water treatment system.
- Impurities in water
- PreTreatment techniques used
- Ion removal techniques such as reverse osmosis and ion-exchange
- It also describes further ion removal techniques
- Distillation system and pure steam generation
- Water storage system and accessories reqiured
- Ozone system and accosories
- Various polishing components used
- Design and installation of Distillation system
- Materials uses in Distillation syetem
- Various controls and instrumentation
- Water specification guilines
- System installation procedure
- Specification guidelines
- Start up and commissioning procedure
- System Validation --the most Important one
A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries―used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.
Drawing on the author’s extensive field experience with more than 400 pharmaceutical and related water purification systems, the text’s numerous case studies illuminate the best and worst of water system design and operation.
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