A key design attribute of a terminally sterilized medical device is for the device to maintain sterility throughout the labeled shelf-life. This presentation discusses a few of the elements that are necessary for a successful packaging shelf-life.
ISO 10993-7 Biological Evaluation of Medical Devices - Ethylene Oxide Sterili...NAMSA
This presentation, ISO 10993-7 Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals, discusses why it is necessary to test ethylene oxide (EO) and how to categorize your device.
ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management ProcessNAMSA
ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management Process discusses what ISO 10993-1 addresses, as well as the general principles governing the biological evaluation of medical devices within a risk management process.
The document discusses ISO 10993, which provides guidance for conducting biological evaluations of medical devices to assess safety. It consists of multiple parts that cover areas like test methods, reference materials, animal welfare, characterization of materials, and degradation products. The strategy is to use a risk management framework per ISO 10993-1 to determine what testing is necessary based on understanding the device, materials, and risks, drawing on existing knowledge where possible. Only gaps in knowledge need be filled through appropriate testing to adequately evaluate biological safety.
This document lists several ISO standards related to risk management, product safety testing, environmental management, food safety, and microbiological testing. Key standards addressed include ISO 10993 for biocompatibility assessment of medical devices, ISO 14000 for environmental management systems, ISO 22000 for food safety management systems, ISO 31000 for risk management principles and guidelines, and ISO 6579 for detecting Salmonella in food and animal feed.
Presentation given at SMI's Biosimilar and Biobetter Conference 2015 in London. The presentation discusses challenges and opportunities for developers of biosimilar products and how medical device components can provide a competitive advantage.
Wu xi apptec lab testing division overview 2016Linda Zhao
WuXi AppTec's Laboratory Testing Division is a large growth engine that provides integrated testing solutions to support drug development, clinical diagnostics, and medical device testing. It has over 1,600 employees across sites in China and the US. The division offers a full range of preclinical and clinical services, including CMC development, safety and efficacy testing, bioanalysis, and biomarker analysis. It also has platforms for in vitro diagnostics and medical device testing. The division aims to transform scientific ideas into healthcare products to better serve patients.
The document summarizes CPSC requirements for adult and children's clothing, including mandatory safety standards and voluntary standards. It discusses four types of safety concerns, strategies to prevent product hazards, and CPSC's role in monitoring voluntary standards and issuing technical regulations if needed to reduce risks. Key requirements outlined are flammability testing, tracking labels, lead and phthalate limits, and restrictions on drawstrings for children's garments. Manufacturers are responsible for ensuring imported products comply with both U.S. regulations and voluntary consensus standards.
Material characterization per ISO 10993-18: When is it needed & how do I sati...UBMCanon
ISO 10993 provides guidance on biological evaluation of medical devices and consists of various parts covering topics like cytotoxicity, irritation, and systemic toxicity testing. Material characterization as outlined in Part 18 involves identifying all components that can migrate or leach out of a medical device under various conditions through extractable and leachable testing. Extractables are compounds that can migrate under aggressive extraction whereas leachables are those that migrate under normal exposure conditions. Understanding potential leachable sources from materials like polymers, metals, and residues is important for ensuring a comprehensive extractable/leachable profile.
ISO 10993-7 Biological Evaluation of Medical Devices - Ethylene Oxide Sterili...NAMSA
This presentation, ISO 10993-7 Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals, discusses why it is necessary to test ethylene oxide (EO) and how to categorize your device.
ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management ProcessNAMSA
ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management Process discusses what ISO 10993-1 addresses, as well as the general principles governing the biological evaluation of medical devices within a risk management process.
The document discusses ISO 10993, which provides guidance for conducting biological evaluations of medical devices to assess safety. It consists of multiple parts that cover areas like test methods, reference materials, animal welfare, characterization of materials, and degradation products. The strategy is to use a risk management framework per ISO 10993-1 to determine what testing is necessary based on understanding the device, materials, and risks, drawing on existing knowledge where possible. Only gaps in knowledge need be filled through appropriate testing to adequately evaluate biological safety.
This document lists several ISO standards related to risk management, product safety testing, environmental management, food safety, and microbiological testing. Key standards addressed include ISO 10993 for biocompatibility assessment of medical devices, ISO 14000 for environmental management systems, ISO 22000 for food safety management systems, ISO 31000 for risk management principles and guidelines, and ISO 6579 for detecting Salmonella in food and animal feed.
Presentation given at SMI's Biosimilar and Biobetter Conference 2015 in London. The presentation discusses challenges and opportunities for developers of biosimilar products and how medical device components can provide a competitive advantage.
Wu xi apptec lab testing division overview 2016Linda Zhao
WuXi AppTec's Laboratory Testing Division is a large growth engine that provides integrated testing solutions to support drug development, clinical diagnostics, and medical device testing. It has over 1,600 employees across sites in China and the US. The division offers a full range of preclinical and clinical services, including CMC development, safety and efficacy testing, bioanalysis, and biomarker analysis. It also has platforms for in vitro diagnostics and medical device testing. The division aims to transform scientific ideas into healthcare products to better serve patients.
The document summarizes CPSC requirements for adult and children's clothing, including mandatory safety standards and voluntary standards. It discusses four types of safety concerns, strategies to prevent product hazards, and CPSC's role in monitoring voluntary standards and issuing technical regulations if needed to reduce risks. Key requirements outlined are flammability testing, tracking labels, lead and phthalate limits, and restrictions on drawstrings for children's garments. Manufacturers are responsible for ensuring imported products comply with both U.S. regulations and voluntary consensus standards.
Material characterization per ISO 10993-18: When is it needed & how do I sati...UBMCanon
ISO 10993 provides guidance on biological evaluation of medical devices and consists of various parts covering topics like cytotoxicity, irritation, and systemic toxicity testing. Material characterization as outlined in Part 18 involves identifying all components that can migrate or leach out of a medical device under various conditions through extractable and leachable testing. Extractables are compounds that can migrate under aggressive extraction whereas leachables are those that migrate under normal exposure conditions. Understanding potential leachable sources from materials like polymers, metals, and residues is important for ensuring a comprehensive extractable/leachable profile.
The document discusses investigations into a failed sterility test of a product. It describes the perspectives and concerns of different stakeholders when a sterility failure occurs, including the technician, lab director, quality assurance, manufacturer, and client. It then details the steps of a thorough investigation conducted by an expert to find the root cause, involving reviewing laboratory and production records, environmental monitoring data, personnel training, and sources of raw materials. The investigation found the likely cause was contamination from cardboard boxes used to package sterile containers in the laboratory rather than any issues with production, raw materials, or personnel.
Innovative Hospital Partnership Model for High Quality Patient Clinical TrialsSGS
This document describes an innovative hospital partnership model for high quality patient clinical trials in Central and Eastern Europe. Specifically, it discusses a case study of an oncology trial involving a partnership between SGS, a clinical research organization, and hospitals in the region. The key aspects of the model include SGS establishing satellite patient units within selected hospitals to increase access to patients while maintaining functional ownership over trial operations. This allows SGS to leverage its clinical expertise and quality systems to successfully execute trials at these partner hospital sites. The document then provides details on an existing partnership in Belgium and a proposed partnership for a satellite unit in Hungary to support oncology trials across Central and Eastern Europe.
Generic drug companies are relying heavily on qualified contract research organizations (CROs) to accelerate their development processes and be first to market after patents expire on branded drugs. CROs provide expertise across development areas like preclinical research, clinical trials management, bioequivalence studies, analytical testing, and ANDA submissions that help generics meet tight deadlines. Successfully demonstrating bioequivalence through bioavailability and dissolution studies is key for regulatory approval and requires CROs with strong laboratory capabilities and experience navigating regulatory requirements.
Where are you in your drug development journey? Find out how to expedite your drug development program. View our drug development journey map. Download the document to zoom in and view details.
This guidance provides recommendations for holders of animal drug applications on reporting categories for changes to conditions established in approved applications. It describes changes to manufacturing sites, scales, equipment, specifications, and processes for synthetic drug substances and intermediates. The guidance recommends reporting categories of annual reports, supplements for changes being effected in 30 days, or prior approval supplements based on the type and potential impact of changes.
This document provides guidance on planning preclinical testing for medical device development. It outlines key aspects to consider, including material selection, manufacturing methods, biocompatibility testing, study design, packaging and sterilization validation. Manufacturers are advised to review industry standards, evaluate all potential impacts to safety and performance, and plan timelines for all required activities and documentation. Attention to these details at the preclinical stage will help ensure a successful medical device design validation process.
Considerations to Extractables and Leachables Testing SGS
How to organize Extractables Assessments? FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, and Process Validation, and recently to include failures of manufacturers in Risk Management. The evaluation of extractables and leachables has become an increasingly important aspect in the Quality by Design (QbD) initiative of the FDA in the area of drug product design, including materials used in the drug product production process and container and closure systems used for product packaging. This presentation provides general approaches and practical aspects in E&L testing.
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
The document discusses the regulatory IND (Investigational New Drug) process for bringing a new drug to market in the United States. It outlines the requirements for submitting an IND application to the FDA, including non-clinical data from animal and early human studies demonstrating safety and effectiveness. Key components that must be addressed are chemistry and manufacturing controls, pharmacology and toxicology data, clinical protocols, and plans for interaction and meetings with FDA regulators during the process.
The Evolving Quality Expectations & Reshaping Strategy of Controls in Pharmac...Obaid Ali / Roohi B. Obaid
Seminar on "Advanced Pharmaceutical Technology & Practice to Compliance with Challenging Standards" organized by Austar, China & Morgan, Pakistan attended by over hundred participants from different pharmaceutical industries of Karachi & Lahore
Impact of Sample Handling and Processing on Bioanalycial OutcomeSGS
Data from clinical assays (biomarkers, PK, PD, and immunogenicity) are often key outcomes from clinical trials. Implementing these endpoints in clinical trials is very costly and also time - and resource-consuming. Therefore, ensuring that appropriate measures are taken from the collection of samples until the completion of laboratory testing is paramount.
The purpose of this presentation is to discuss the challenges and potential pitfalls of sample collection, processing, and storage on the final bioanalytical endpoints and laboratory assays. Key parameters affecting various assay endpoints will be discussed and illustrated with specific examples, highlighting the SGS approach to handling and controlling these critical activities for the successful delivery of these studies outcomes.
Contact Us: clinicalresearch@sgs.com
Visit our Website: http://www.sgs.com/cro
Follow Us on LinkedIn: http://bit.ly/SGSLifeSciences
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
The Investigational Medicinal Product Dossier (IMPD) provides key data about investigational drugs used in clinical trials in the European Union. It includes summaries of quality, manufacturing, non-clinical, and previous clinical data. The IMPD aims to harmonize information requirements for clinical trial authorization across EU member states. It can take a full or simplified format depending on previous assessments. In addition to the IMPD, other documents like the clinical trial protocol, informed consent form, and investigator's brochure must be submitted for approval to conduct a clinical trial.
This document provides an overview of extractables and leachables (E&Ls) studies. It discusses that E&Ls studies are needed in industries like biomedical devices, food packaging, and pharmaceutical packaging to identify substances that can migrate from materials into products. Jordi Labs is introduced as a leader in E&Ls analysis with state-of-the-art facilities and over 80% of staff being chemists. The document outlines the basic process of an E&L study including sample selection, extractions, identification of E&Ls using techniques like mass spectrometry, quantitative analysis, and determining acceptable levels. Regulations for E&Ls from organizations like USP, FDA and ISO are also summarized.
The document discusses Investigational Medicinal Product Dossier (IMPD) and Investigators Brochure (IB). It provides details on the components and information that should be included in an IMPD and IB. An IMPD includes quality, non-clinical and clinical data on an investigational product and is required for approval of clinical trials in the EU. It also lists additional documents that must accompany the IMPD like the protocol, investigator information and labeling. An IB provides investigators information on the rationale, safety monitoring and risks of an investigational product from pre-clinical and clinical studies to facilitate trial conduct. It outlines the content and sections that should be contained in an IB.
This document summarizes key issues regarding drug quality in Pakistan. It discusses how drug quality cannot be seen by the naked eye or tested in a laboratory, but must be built in from the beginning. It notes that consumers typically cannot see a drug's quality and that the drug tested may not be the one used. The document then outlines the development process for generic drugs, including bioequivalence studies, plant inspections, and ensuring consistency. It provides some facts about Pakistan's regulatory authority and pharmaceutical exports. The overall message is that patients and doctors assume drugs will be safe, effective, and consistently deliver their claimed effects.
NABL is the National Accreditation Board for Testing and Calibration Laboratories in India. It provides accreditation to laboratories, medical testing facilities, proficiency testing providers, and reference material producers to formally recognize their technical competence. Accreditation has several benefits, including increased confidence in test and calibration reports, potential increased business, and acceptance in domestic and international markets. NABL currently provides accreditation in various fields including testing, calibration, medical laboratories, proficiency testing, and reference material production.
Presentation made to MD&M MN Conference in 2006 by Tom Misik, VP Sales Belco Packaging Systems, Inc.
Equipment Considerations For Thermoformed Tray Sealing On Shuttle Style Heat Sealers
SO (7 - 2 A) Terminal Sterlization Qualifications, Fundamentals & Spotlight o...Obaid Ali / Roohi B. Obaid
The document discusses terminal sterilization qualification and provides an overview of some key scenarios related to sterile operations for parenteral preparations. It touches on topics like the importance of terminal sterilization as the preferred method when feasible, validation of sterilization processes, design space parameters, change control, case studies on what can go wrong with sterilization, and historical incidents highlighting the importance of process validation and documentation.
The document discusses investigations into a failed sterility test of a product. It describes the perspectives and concerns of different stakeholders when a sterility failure occurs, including the technician, lab director, quality assurance, manufacturer, and client. It then details the steps of a thorough investigation conducted by an expert to find the root cause, involving reviewing laboratory and production records, environmental monitoring data, personnel training, and sources of raw materials. The investigation found the likely cause was contamination from cardboard boxes used to package sterile containers in the laboratory rather than any issues with production, raw materials, or personnel.
Innovative Hospital Partnership Model for High Quality Patient Clinical TrialsSGS
This document describes an innovative hospital partnership model for high quality patient clinical trials in Central and Eastern Europe. Specifically, it discusses a case study of an oncology trial involving a partnership between SGS, a clinical research organization, and hospitals in the region. The key aspects of the model include SGS establishing satellite patient units within selected hospitals to increase access to patients while maintaining functional ownership over trial operations. This allows SGS to leverage its clinical expertise and quality systems to successfully execute trials at these partner hospital sites. The document then provides details on an existing partnership in Belgium and a proposed partnership for a satellite unit in Hungary to support oncology trials across Central and Eastern Europe.
Generic drug companies are relying heavily on qualified contract research organizations (CROs) to accelerate their development processes and be first to market after patents expire on branded drugs. CROs provide expertise across development areas like preclinical research, clinical trials management, bioequivalence studies, analytical testing, and ANDA submissions that help generics meet tight deadlines. Successfully demonstrating bioequivalence through bioavailability and dissolution studies is key for regulatory approval and requires CROs with strong laboratory capabilities and experience navigating regulatory requirements.
Where are you in your drug development journey? Find out how to expedite your drug development program. View our drug development journey map. Download the document to zoom in and view details.
This guidance provides recommendations for holders of animal drug applications on reporting categories for changes to conditions established in approved applications. It describes changes to manufacturing sites, scales, equipment, specifications, and processes for synthetic drug substances and intermediates. The guidance recommends reporting categories of annual reports, supplements for changes being effected in 30 days, or prior approval supplements based on the type and potential impact of changes.
This document provides guidance on planning preclinical testing for medical device development. It outlines key aspects to consider, including material selection, manufacturing methods, biocompatibility testing, study design, packaging and sterilization validation. Manufacturers are advised to review industry standards, evaluate all potential impacts to safety and performance, and plan timelines for all required activities and documentation. Attention to these details at the preclinical stage will help ensure a successful medical device design validation process.
Considerations to Extractables and Leachables Testing SGS
How to organize Extractables Assessments? FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, and Process Validation, and recently to include failures of manufacturers in Risk Management. The evaluation of extractables and leachables has become an increasingly important aspect in the Quality by Design (QbD) initiative of the FDA in the area of drug product design, including materials used in the drug product production process and container and closure systems used for product packaging. This presentation provides general approaches and practical aspects in E&L testing.
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
The document discusses the regulatory IND (Investigational New Drug) process for bringing a new drug to market in the United States. It outlines the requirements for submitting an IND application to the FDA, including non-clinical data from animal and early human studies demonstrating safety and effectiveness. Key components that must be addressed are chemistry and manufacturing controls, pharmacology and toxicology data, clinical protocols, and plans for interaction and meetings with FDA regulators during the process.
The Evolving Quality Expectations & Reshaping Strategy of Controls in Pharmac...Obaid Ali / Roohi B. Obaid
Seminar on "Advanced Pharmaceutical Technology & Practice to Compliance with Challenging Standards" organized by Austar, China & Morgan, Pakistan attended by over hundred participants from different pharmaceutical industries of Karachi & Lahore
Impact of Sample Handling and Processing on Bioanalycial OutcomeSGS
Data from clinical assays (biomarkers, PK, PD, and immunogenicity) are often key outcomes from clinical trials. Implementing these endpoints in clinical trials is very costly and also time - and resource-consuming. Therefore, ensuring that appropriate measures are taken from the collection of samples until the completion of laboratory testing is paramount.
The purpose of this presentation is to discuss the challenges and potential pitfalls of sample collection, processing, and storage on the final bioanalytical endpoints and laboratory assays. Key parameters affecting various assay endpoints will be discussed and illustrated with specific examples, highlighting the SGS approach to handling and controlling these critical activities for the successful delivery of these studies outcomes.
Contact Us: clinicalresearch@sgs.com
Visit our Website: http://www.sgs.com/cro
Follow Us on LinkedIn: http://bit.ly/SGSLifeSciences
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
The Investigational Medicinal Product Dossier (IMPD) provides key data about investigational drugs used in clinical trials in the European Union. It includes summaries of quality, manufacturing, non-clinical, and previous clinical data. The IMPD aims to harmonize information requirements for clinical trial authorization across EU member states. It can take a full or simplified format depending on previous assessments. In addition to the IMPD, other documents like the clinical trial protocol, informed consent form, and investigator's brochure must be submitted for approval to conduct a clinical trial.
This document provides an overview of extractables and leachables (E&Ls) studies. It discusses that E&Ls studies are needed in industries like biomedical devices, food packaging, and pharmaceutical packaging to identify substances that can migrate from materials into products. Jordi Labs is introduced as a leader in E&Ls analysis with state-of-the-art facilities and over 80% of staff being chemists. The document outlines the basic process of an E&L study including sample selection, extractions, identification of E&Ls using techniques like mass spectrometry, quantitative analysis, and determining acceptable levels. Regulations for E&Ls from organizations like USP, FDA and ISO are also summarized.
The document discusses Investigational Medicinal Product Dossier (IMPD) and Investigators Brochure (IB). It provides details on the components and information that should be included in an IMPD and IB. An IMPD includes quality, non-clinical and clinical data on an investigational product and is required for approval of clinical trials in the EU. It also lists additional documents that must accompany the IMPD like the protocol, investigator information and labeling. An IB provides investigators information on the rationale, safety monitoring and risks of an investigational product from pre-clinical and clinical studies to facilitate trial conduct. It outlines the content and sections that should be contained in an IB.
This document summarizes key issues regarding drug quality in Pakistan. It discusses how drug quality cannot be seen by the naked eye or tested in a laboratory, but must be built in from the beginning. It notes that consumers typically cannot see a drug's quality and that the drug tested may not be the one used. The document then outlines the development process for generic drugs, including bioequivalence studies, plant inspections, and ensuring consistency. It provides some facts about Pakistan's regulatory authority and pharmaceutical exports. The overall message is that patients and doctors assume drugs will be safe, effective, and consistently deliver their claimed effects.
NABL is the National Accreditation Board for Testing and Calibration Laboratories in India. It provides accreditation to laboratories, medical testing facilities, proficiency testing providers, and reference material producers to formally recognize their technical competence. Accreditation has several benefits, including increased confidence in test and calibration reports, potential increased business, and acceptance in domestic and international markets. NABL currently provides accreditation in various fields including testing, calibration, medical laboratories, proficiency testing, and reference material production.
Presentation made to MD&M MN Conference in 2006 by Tom Misik, VP Sales Belco Packaging Systems, Inc.
Equipment Considerations For Thermoformed Tray Sealing On Shuttle Style Heat Sealers
SO (7 - 2 A) Terminal Sterlization Qualifications, Fundamentals & Spotlight o...Obaid Ali / Roohi B. Obaid
The document discusses terminal sterilization qualification and provides an overview of some key scenarios related to sterile operations for parenteral preparations. It touches on topics like the importance of terminal sterilization as the preferred method when feasible, validation of sterilization processes, design space parameters, change control, case studies on what can go wrong with sterilization, and historical incidents highlighting the importance of process validation and documentation.
The CPSC uses a multi-pronged strategy to protect consumers that includes education and outreach to manufacturers domestically and abroad, import surveillance to inspect products entering US ports, and decisive enforcement responses like recalls or penalties. The CPSC conducts extensive testing of products, educates small businesses, and works with global partners and universities. The Consumer Product Safety Improvement Act of 2008 established requirements for children's products, including lead limits, phthalates bans, third-party testing, and certification.
This document provides an overview of the Consumer Product Safety Commission's third party testing program requirements. It discusses the requirements for initial certification testing, component part testing, material change testing, and periodic testing that manufacturers must follow to certify that children's products comply with safety standards. It also outlines the recordkeeping responsibilities and reasonable testing program best practices for non-children's products. The presentation emphasizes exercising due care in relying on third party test results and avoiding any undue influence on testing laboratories.
The document provides an overview of packaging validations according to ISO 11607 Part 1. It discusses determining appropriate sample sizes based on statistically valid rationales and factors to consider. It also covers writing a validation protocol, developing a test plan, test method options, family grouping, worst-case considerations, and creating validation samples. The document aims to provide guidance on conducting packaging validations in compliance with ISO 11607 standards.
Disposable instruments and procedural kits undergo comprehensive product development and testing to meet quality and regulatory requirements. Extensive validation and verification testing is performed on packaging, sterilization methods, aging, and the instruments themselves to ensure clinical robustness. This includes testing instruments through simulated clinical reprocessing cycles to validate they can withstand repeated cleaning, sterilization, and use over their intended lifetimes. Understanding how instruments will perform after many reprocessing cycles is important for material selection, design, and establishing appropriate cleaning and sterilization instructions.
Overview of testing, certification, and record keeping requirements for consumer products, including children's products. Addresses initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed.
DDL Incorporated provides medical device and pharmaceutical package testing services. They have testing capabilities for package strength and integrity, environmental testing from -70C to 200C, and material testing. They use standardized methods and have a quality management process to test packages and ensure sterile barrier integrity and thermal performance over time under various conditions. They are involved in professional associations and standards committees related to packaging and testing.
GLP (Good Laboratory Practice) is a quality system with defined standards for conducting studies and reporting results. It ensures uniformity, consistency, reliability and reproducibility of testing through elements like SOPs, personnel roles, equipment validation and laboratory safety practices. Key aspects of GLP include establishing an independent quality assurance unit, documenting all study activities, ensuring personnel are qualified and equipment is properly maintained and calibrated, and archiving records for a defined period of time. Following GLP helps provide reasonable assurance that study results were collected as outlined and can be relied upon, even if it does not guarantee the scientific merit of the study itself.
The document summarizes new rules for third party testing of children's products that took effect in 2013. It outlines requirements for initial certification testing, component part testing, material change testing, and periodic testing for continued production. Manufacturers must have products tested by accredited laboratories, issue certificates of compliance, and maintain testing records. The rules aim to provide assurance that children's products meet safety standards for substances like lead and phthalates.
Overview of third party testing children's products, including initial certification testing, material change testing, component part testing, and periodic testing. Discussion of recordkeeping requirements and undue influence training requirements.
Documentation with respect to release of finished pharmaceutical productMadhuraNewrekar
Documentation is a crucial part of the quality assurance system and is needed in every aspect of pharmaceutical manufacturing. Important documentation with respect to final product release in pharmaceutical industry is explained in brief.
The document discusses laboratory controls required by cGMP regulations. It provides an overview of Subpart I, which establishes requirements for laboratory controls, testing and release of products, stability testing, special testing, reserve samples, and laboratory animals. The document emphasizes that laboratory data is essential to prove manufacturing processes and products are suitable and ensure consistent product quality. It warns that unreliable test methods can pose risks to both consumers and manufacturers.
This document discusses periodic testing requirements for children's products. It explains that periodic testing must be conducted by a CPSC-accepted third party laboratory, with the required frequency depending on the manufacturer's chosen option - either annually, every 2 years if a production testing plan is established, or every 3 years if using an ISO-accredited lab for continued testing. The frequency may also need to be more than annually based on factors like variability in test results or potential for serious injury. Manufacturers must document their periodic testing plan and maintain testing records for 5 years. Component part testing by suppliers can be relied on if certain conditions are met.
Devices Sponsor Information Day: 1 - Conformity AssessmentTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
The document provides guidance on establishing hold times during pharmaceutical manufacturing to ensure materials and products remain stable and of acceptable quality. It discusses key aspects to consider in designing hold time studies, including identifying critical stages of production, testing parameters, storage conditions representative of production, and statistical analysis of data. Table A4.1 gives examples of potential stages, study times, and tests for a coated tablet from binder preparation through final packaging. The guidance aims to help manufacturers demonstrate materials and products meet specifications and quality requirements during established hold periods.
Documentation control - principles of GMPAJAYKUMAR4872
Documentation is an essential part of QA and relates to all aspects of GMP.
The pharmaceutical industry must have a good document framework (infrastructure).
It is important for a manufacturer to get the documentation right in order to get the product right.
This document discusses three levels of quality checks that are critical for building facades: 1) Product design, 2) Product manufacturing, and 3) System design and execution.
It provides examples to illustrate each level, including testing standards for product design compliance, certification processes for ensuring consistent manufacturing quality, and the use of mockups and on-site testing to validate custom system designs.
Proper quality checks at all three levels through standards compliance, third-party certification, and performance testing can help stakeholders deliver facade systems that meet design specifications and perform as intended over a building's lifespan.
This document discusses pilot plant scale-up techniques for pharmaceutical manufacturing. It defines a pilot plant and scale-up process. The key steps in scale-up involve conducting laboratory and smaller pilot studies, designing and constructing a pilot plant, evaluating results to make corrections, and deciding whether to proceed to full-scale production. General considerations for a pilot plant include personnel requirements, equipment, production rates, process evaluation, and ensuring product stability and uniformity. GMP must also be followed in areas like process validation and documentation.
This document discusses pilot plant scale-up techniques for pharmaceutical manufacturing. It defines a pilot plant and scale-up process. The key steps in scale-up involve conducting laboratory and smaller pilot studies, designing and constructing a pilot plant, evaluating results to make corrections, and deciding whether to proceed to full-scale production. General considerations for a pilot plant include personnel requirements, equipment, production rates, process evaluation, and ensuring product stability and uniformity. GMP must also be followed in areas like process validation and documentation.
Similar to Components of a Successful Packaging Shelf-Life Study (20)
Common Mistakes in the Medical Device Development ContinuumNAMSA
Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can be made with the device. And even after market approval has been obtained, there is a continuous need to reevaluate and test the device to maintain safety and efficacy.
Throughout this development process, several steps can be missed that may result in submission refusal, or possibly a faulty device.
ISO 10993-6: Biological Evaluation of Medical Devices - Tests for local effec...NAMSA
ISO 10993-6 helps identify appropriate implantation sites, how long implants should remain in place during testing, implantation methods and biological responses at the macro- and microscopic level.
ISO 10993-5 Biological Evaluation of Medical Devices - Tests for In Vitro Cyt...NAMSA
ISO 10993-5 presents test methods for evaluating the acute adverse effects of extractables from medical device materials. Testing cytotoxicity is a requirement for all medical devices. Different cytotoxicity methods include qualitative elution assays, agar overlay tests, direct contact tests, and quantitative assays like MTT and colony formation that allow endpoint evaluation. Controls include negative articles like HDPE tubing and positive references like latex and chemicals containing ZDEC and ZDBC.
ISO 10993-4 Biological Evaluation of Medical Devices - Tests for Interactions...NAMSA
ISO 10993-4 Biological Evaluation of Medical Devices - Tests for Interactions with Blood provides a structured test-selection system based on the intended use of the device. Although it does not provide detailed test methods or evaluation criteria, it cites various applicable references.
ISO 10993-3: Biological Evaluation of Medical Devices - Tests for Genotoxicit...NAMSA
ISO 10993-3: Biological Evaluation of Medical Devices discusses how to identify when genotoxicity, carcinogenicity or reproductive toxicity testing is necessary for a medical device.
Meta Analysis of Medical Device Data Applications for Designing Studies and R...NAMSA
This document discusses meta-analysis and its uses in medical device research. Meta-analysis statistically combines findings from multiple studies to reach a stronger conclusion. It can improve estimates of a treatment's effects, resolve uncertain or contradictory evidence from individual studies, and allow for smaller clinical studies by drawing from existing evidence. There are two main types of meta-analysis: individual participant data uses raw data from each subject, while aggregate data meta-analysis (more common) analyzes summary results across studies.
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...NAMSA
The document summarizes China's regulatory approval process for medical devices. It outlines the testing process manufacturers must go through, including writing custom product standards and undergoing variable performance testing at CFDA-designated sites. Recent changes require Class I devices to file documentation rather than register, and Class II and III devices to conduct clinical trials for approval, with some exceptions. IVD registration requirements also changed, with Class I through filing, and Classes II and III requiring registration and trials.
ISO 10993 Biological Evaluation of Medical Devices UpdateNAMSA
The ISO 10993 Biological Evaluation of Medical Devices Update covers the revisions/updates that were discussed at the TC194 meeting in Mishima, Japan in April of 2014.
Use of Chemical Characterization to Assess the Equivalency of Medical Devices...NAMSA
Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials describes chemical characterization techniques and why they are important.
Practical Biostatistics for Clinical Trials: How to Find and Use Your Biostat...NAMSA
Practical Biostatistics for Clinical Trials: How to Find and Use Your Biostatistician focusses on how to go about finding and using your biostatistician.
Interim Analysis of Clinical Trial Data: Implementation and Practical AdviceNAMSA
This document discusses interim analyses of clinical trial data. It describes different types of interim analyses including early stopping for safety or efficacy, sample size re-assessments, and administrative analyses. Early stopping for safety is generally done by a data monitoring committee to ensure participant safety. Early stopping for efficacy can determine whether a trial meets success criteria or shows futility. Sample size can be re-estimated based on nuisance parameters or treatment effects. Interim analyses are most useful when the alternative hypothesis is uncertain, enrollment is slow, or endpoints are acute. The document recommends doing some form of interim analysis or monitoring in almost all cases.
Introduction to NAMSA's Certification ProgramNAMSA
This presentation is a brief introduction to NAMSA Course A: Biocompatibility of Medical Devices Two Day Certification. You will be given a brief outline of what the NAMSA Boston Event has to offer.
The Current Regulatory Thinking in Reprocessing seminar discusses standards and guidance for reprocessing and reusable medical devices as well as insights into the development and validation process.
Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Mar...NAMSA
Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets is the first of many Remote Training Series that NAMSA does. This first series discusses and evaluates emerging markets and the opportunities and challenges that follow.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
4. Initial inputs related to the packaging design and packaging
4
materials are key
5. Initial inputs related to the packaging design and packaging
5
materials are key
These are lengthy studies that have to be re-started form
time 0 if not addressed up front. Time is money!
6. Initial inputs related to the packaging design and packaging
6
materials are key
These are lengthy studies that have to be re-started form
time 0 if not addressed up front. Time is money!
Review what method of sterilization is intended to be
chosen for the device and the proposed package
Certain types of packaging materials are needed for certain
sterilization modes
7. Initial inputs related to the packaging design and packaging
7
materials are key
These are lengthy studies that have to be re-started form
time 0 if not addressed up front. Time is money!
Review what method of sterilization is intended to be
chosen for the device and the proposed package
Certain types of packaging materials are needed for certain
sterilization modes
Single barrier versus double barrier package design
Input is essential from users (nurses, doctors). Obtain Voice of
the Customer (VOC) feedback. And don’t forget your marketing
partners!
8. The decision on how long of a shelf life you would like to
8
claim
9. The decision on how long of a shelf life you would like to
9
claim
The inputs here are:
Operational – how long do you want this product to be “saleable”
10. The decision on how long of a shelf life you would like to
10
claim
The inputs here are:
Operational – how long do you want this product to be “saleable”
Functional – are there product functionality characteristics that are
part of the product design inputs that are a limiting factor
11. The decision on how long of a shelf life you would like to
11
claim
The inputs here are:
Operational – how long do you want this product to be “saleable”
Functional – are there product functionality characteristics that are
part of the product design inputs that are a limiting factor
Sealing equipment validations
Key component PRIOR to starting the Shelf-life study is to
ensure the sealing equipment has been validated
12. The decision on how long of a shelf life you would like to
12
claim
The inputs here are:
Operational – how long do you want this product to be “saleable”
Functional – are there product functionality characteristics that are
part of the product design inputs that are a limiting factor
Sealing equipment validations
Key component PRIOR to starting the Shelf-life study is to
ensure the sealing equipment has been validated
Sample quantities
Ensure that enough samples have been produced to satisfy
both the Accelerated and Real-Time Testing intervals
14. 14
Sample preparation
Ensure the packaging equipment has been properly
validated for the package/device being tested
15. 15
Sample preparation
Ensure the packaging equipment has been properly
validated for the package/device being tested
Optional – Determine device to represent product family
of devices for this design
16. 16
Sample preparation
Ensure the packaging equipment has been properly
validated for the package/device being tested
Optional – Determine device to represent product family
of devices for this design
Seal devices within the validated parameters
17. 17
Sample preparation
Ensure the packaging equipment has been properly
validated for the package/device being tested
Optional – Determine device to represent product family
of devices for this design
Seal devices within the validated parameters
Sterilize at maximum exposure conditions
Radiation = upper dose or greater
Ethylene Oxide = double exposure
Other sterilization processes can use the same logic
18. 18
Accelerated Aging Conditions
Based on product and package material compatibility,
determine temperatures that will not damage package or
device
19. 19
Accelerated Aging Conditions
Based on product and package material compatibility,
determine temperatures that will not damage package or
device
ASTMF1980
Accelerated aging is based on thermodynamic
dependence on reaction rates
20. 20
Accelerated Aging Conditions
Based on product and package material compatibility,
determine temperatures that will not damage package or
device
ASTMF1980
Accelerated aging is based on thermodynamic
dependence on reaction rates
Arrhenius reaction rate function is that, for many
common chemical reactions at room temperature, the
reaction rate doubles for every 10 degree Celsius
increase in temperature (Q10).
22. ISO 11607-1 outlines that sampling plans should be based
22
on a statistically valid rationale
23. ISO 11607-1 outlines that sampling plans should be based
23
on a statistically valid rationale
As stated there is not a standard number of samples
required, so how do you choose?
24. ISO 11607-1 outlines that sampling plans should be based
24
on a statistically valid rationale
As stated there is not a standard number of samples
required, so how do you choose?
Utilize ISO 2859 (similar to ANSI/ASQ Z1.4) for inputs
base on lot/batch sizes and inspections levels
25. ISO 11607-1 outlines that sampling plans should be based
25
on a statistically valid rationale
As stated there is not a standard number of samples
required, so how do you choose?
Utilize ISO 2859 (similar to ANSI/ASQ Z1.4) for inputs
base on lot/batch sizes and inspections levels
Typically it would be Inspection Level II
26. ISO 11607-1 outlines that sampling plans should be based
26
on a statistically valid rationale
As stated there is not a standard number of samples
required, so how do you choose?
Utilize ISO 2859 (similar to ANSI/ASQ Z1.4) for inputs
base on lot/batch sizes and inspections levels
Typically it would be Inspection Level II
Utilize in-house quality experts for determinations to
satisfy “your” company’s requirements
27. ISO 11607-1 outlines that sampling plans should be based
27
on a statistically valid rationale
As stated there is not a standard number of samples
required, so how do you choose?
Utilize ISO 2859 (similar to ANSI/ASQ Z1.4) for inputs
base on lot/batch sizes and inspections levels
Typically it would be Inspection Level II
Utilize in-house quality experts for determinations to
satisfy “your” company’s requirements
Usually NAMSA recommends to send a minimum of 10
samples per test input per time point
28. To view the complete Remote Training Series on
Components of a Successful Packaging Shelf-Life Study
Check out NAMSA’s Seminars
For information about the Packaging Shelf Life services
NAMSA can offer you
Visit our Packaging Validation and Shelf Life Testing
28
page
For additional information
Contact us at clientcare@namsa.com.