This document discusses 5 costly mistakes that can occur during research and development of personal care products: 1) incorrect preservative selection, 2) ingredient incompatibilities, 3) inefficient development time, 4) inadequate scale up procedures, and 5) insufficient stability testing. It provides examples of each mistake and recommends steps companies can take to avoid them, such as conducting proper preservative efficacy testing, checking for ingredient compatibilities, setting realistic budgets and timelines, scaling up in increments, and performing accelerated and long-term stability studies. The document promotes educational courses from the Institute of Personal Care Science that teach formulation, brand management, and regulatory compliance.
This professional profile summarizes the experience and qualifications of Kanish Jose. He has over 15 years of experience in quality assurance and laboratory management roles in the food manufacturing industry. He is skilled in quality assurance frameworks, auditing, documentation, equipment operation, and team leadership. Currently he works as Quality Assurance and Laboratory Manager for Alba Edible Oils, where he created a new quality assurance system from scratch and leads a small quality team.
The document provides details of the candidate's work experience spanning from 1992 to present. It lists their roles as a Chemist and Researcher at Merck Sharp & Dhome from 2000 to present with responsibilities including laboratory testing, ensuring compliance with regulations, and equipment maintenance. It also lists prior roles as a Laboratory Assistant at Mobil Oil Singapore from 1994 to 2000 and GlaxoDevelopment from 1992 to 1994 involving testing of pharmaceutical ingredients using analytical techniques.
Products Liability & the Middle MarketDPSchneider
1. Establishing cross-functional committees and appointing coordinators to oversee the program
2. Implementing controls throughout the product lifecycle from design to post-sale support
3. Maintaining comprehensive documentation and recordkeeping systems
Vita Liquid Polymers is located in Manchester, UK and is part of the larger Vita Group which operates in 14 countries. As a quality control technician, the document's author tested incoming and outgoing materials to ensure products met specifications. They also worked as a development technologist on new product formulations. Through this placement, the author gained experience with various quality control tests, laboratory maintenance, communication, time management, and problem solving skills. They felt the placement provided invaluable real-world experience and improved their professional skills and relationships.
Almost 50% of Recalls in the USA are caused by allergens in a consumer product not indicated on the product's label. Learn more about allergens here: https://www.saiglobal.com/en-us/assurance/food_safety/?utm_source=slideshare&utm_medium=presentation&utm_campaign=food_safety
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.
Arra Nampally is currently an Assistant Manager at Sanofi India, with over 11 years of experience in quality control for pharmaceutical formulations. She has a Master's degree from Periyar University and a BSc from Osmania University. As Assistant Manager, she leads a team and is responsible for day-to-day operations of the quality control microbiology department to ensure goals are achieved. She has experience with audits, equipment qualification, method development and validation, and ensuring regulatory compliance.
SMi Group's 4th annual Lyophilisation Europe 2016 conferenceDale Butler
This document advertises an upcoming conference on lyophilisation (freeze drying) to be held in London from July 4-5, 2016. It provides an agenda for the two-day conference, listing topics such as designing robust freeze drying processes, continuous freeze drying, spray drying, and optimizing filling processes. It also advertises a half-day post-conference workshop on designing and scaling up a freeze drying process to be led by experts from NIBSC and Biopharma Process Systems. The document promotes the conference and workshop opportunities for professionals in lyophilisation, formulation development, bioprocessing and related fields.
This professional profile summarizes the experience and qualifications of Kanish Jose. He has over 15 years of experience in quality assurance and laboratory management roles in the food manufacturing industry. He is skilled in quality assurance frameworks, auditing, documentation, equipment operation, and team leadership. Currently he works as Quality Assurance and Laboratory Manager for Alba Edible Oils, where he created a new quality assurance system from scratch and leads a small quality team.
The document provides details of the candidate's work experience spanning from 1992 to present. It lists their roles as a Chemist and Researcher at Merck Sharp & Dhome from 2000 to present with responsibilities including laboratory testing, ensuring compliance with regulations, and equipment maintenance. It also lists prior roles as a Laboratory Assistant at Mobil Oil Singapore from 1994 to 2000 and GlaxoDevelopment from 1992 to 1994 involving testing of pharmaceutical ingredients using analytical techniques.
Products Liability & the Middle MarketDPSchneider
1. Establishing cross-functional committees and appointing coordinators to oversee the program
2. Implementing controls throughout the product lifecycle from design to post-sale support
3. Maintaining comprehensive documentation and recordkeeping systems
Vita Liquid Polymers is located in Manchester, UK and is part of the larger Vita Group which operates in 14 countries. As a quality control technician, the document's author tested incoming and outgoing materials to ensure products met specifications. They also worked as a development technologist on new product formulations. Through this placement, the author gained experience with various quality control tests, laboratory maintenance, communication, time management, and problem solving skills. They felt the placement provided invaluable real-world experience and improved their professional skills and relationships.
Almost 50% of Recalls in the USA are caused by allergens in a consumer product not indicated on the product's label. Learn more about allergens here: https://www.saiglobal.com/en-us/assurance/food_safety/?utm_source=slideshare&utm_medium=presentation&utm_campaign=food_safety
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.
Arra Nampally is currently an Assistant Manager at Sanofi India, with over 11 years of experience in quality control for pharmaceutical formulations. She has a Master's degree from Periyar University and a BSc from Osmania University. As Assistant Manager, she leads a team and is responsible for day-to-day operations of the quality control microbiology department to ensure goals are achieved. She has experience with audits, equipment qualification, method development and validation, and ensuring regulatory compliance.
SMi Group's 4th annual Lyophilisation Europe 2016 conferenceDale Butler
This document advertises an upcoming conference on lyophilisation (freeze drying) to be held in London from July 4-5, 2016. It provides an agenda for the two-day conference, listing topics such as designing robust freeze drying processes, continuous freeze drying, spray drying, and optimizing filling processes. It also advertises a half-day post-conference workshop on designing and scaling up a freeze drying process to be led by experts from NIBSC and Biopharma Process Systems. The document promotes the conference and workshop opportunities for professionals in lyophilisation, formulation development, bioprocessing and related fields.
This document discusses packaging technologies for two case studies - an artisan seafood producer and a smoked meats manufacturer. For the seafood producer, a polypropylene tray with an antifog film top was chosen to withstand pasteurization at 85C for 30 minutes to achieve over 8 days shelf life. A packaging machine costing €27k was selected. For the smoked meats manufacturer considering upgrading packaging, competitor offerings provided inspiration for more visually appealing options that could be automated.
This summary provides an overview of Desiree Bartley's qualifications and experience:
Desiree Bartley has over 10 years of experience in quality control for the pharmaceutical industry, including experience in biotech, consumer health, and cosmetics manufacturing. She has extensive experience in aseptic techniques such as environmental sampling and quality assurance/quality control activities. Bartley also has certifications in cleanroom behavior, aseptic gowning practices and procedures, and ensuring compliance with Good Manufacturing Practices and FDA regulations.
Some of her key roles include serving as an environmental monitoring subject matter expert and trainer at Pfizer in Pearl River, NY, where she performed quality control activities supporting sterile vaccine production for over 13 years.
This document provides an introduction and overview of a training session on Good Manufacturing Practices (GMP) for the 21st century. It notes that the presentation will reflect the presenter's views and is not meant to represent any official policies. Examples of recent drug contamination and mix-ups are presented to illustrate the importance of GMP in ensuring consistent quality, preventing contamination and mix-ups. GMP is described as a set of regulatory methods to inspect manufacturing practices to protect the integrity and quality of products intended for human use and ensure they are consistently produced and controlled.
Deibel Laboratories has been providing food and personal care product testing services for over 30 years through a network of 12 laboratories across the US that operate 365 days a year. They take a partnership approach to working with clients by providing personalized support to help ensure product quality and safety rather than just reporting results. Many food producers and companies trust Deibel Labs for their quality control protocols, scientific integrity, and customer service to protect their brand names.
Vivek Khare is a business specialist and key account executive with over 8 years of experience in sales and marketing of laboratory products. He is currently employed by AVANTOR PERFORMANCE MATERIALS, where he is responsible for sales promotion, order generation, customer interaction and developing new business. Previously he has worked for Merck Specialties and Biocon Health Care in similar roles handling customers in the pharmaceutical, chemical and research industries. He holds an MBA in Marketing and a BSc in Chemistry.
This document provides an introduction and overview of Failure Mode Effect Analysis (FMEA). FMEA is used across several industries including automotive, aerospace, military, and others to analyze potential failures, their causes and effects. The document outlines the steps to conduct an FMEA, including defining the item or process being analyzed, identifying potential failure modes and their causes and effects, analyzing current prevention and detection controls, and determining a risk priority number. It then provides a sample FMEA analysis for purchasing milk for a lactose intolerant child, identifying potential failures from purchasing the wrong milk to packaging issues, and assessing prevention controls, occurrence, detection and severity to calculate risk.
Karen Campbell is seeking a position that utilizes her experience in quality assurance and process improvement. She has over 30 years of experience in medical laboratories and 13 years as Quality Assurance Manager at ThermoFisher Scientific, where she developed quality processes, standard operating procedures, metric boards, and led corrective actions. She is trained in Lean Enterprise techniques and served as an internal ISO auditor.
This document announces two half-day post-conference workshops on May 10, 2017 at the Copthorne Tara Hotel in London. The morning workshop from 8:30-13:00 is on "Getting the most out of DOE approaches during freeze drying development" and will cover fundamentals of lyophilization development and practical advice on design of experiments approaches. The afternoon workshop from 13:30-17:30 is on "Strategies to achieving process transfer in lyophilisation" and will discuss challenges in transferring lyophilization processes. Both workshops will include presentations, discussions, and case studies from industry experts.
Sudeep Killedar is seeking a career enriching role in business development with a focus on the pharmaceutical industry, leveraging his nearly 9 years of experience in production, process enhancement, packaging, and research documentation for well-known pharmaceutical organizations. He has skills in enhancing production operations, optimizing resources, and ensuring compliance with quality standards and regulatory guidelines. The document provides details on his educational background and work experience in various roles with increasing responsibility in the pharmaceutical industry.
Matthew Eric Hulsey is seeking a challenging career opportunity utilizing his manufacturing experience, chemical engineering expertise, and leadership skills. He has over 3 years of experience in manufacturing and operations management roles at Pepsi Beverages Company, where he supervised production lines and led Lean Six Sigma projects. Previously, he completed an internship at Tyco Fire Protection Products where he evaluated fire suppression chemicals and testing procedures. Hulsey holds a Bachelor of Science in Chemical Engineering from the University of Florida and is proficient in various production, sanitation, and computer software.
The candidate has 13 years of experience in quality management spanning supplier quality, production quality, customer service, and after-sales service. They have set up quality management systems from scratch for two companies, achieving ISO 9001 certification immediately for one and with zero non-conformities for the other. Currently, they are working to develop a quality control system for their company by establishing processes and controls to ensure consistent product quality. Key metrics such as customer complaints, reject rates, and returns have significantly improved since controls were implemented.
Michael Riordan is an enthusiastic and motivated lab technician seeking a position that utilizes his experience in pharmaceutical and industrial chemistry. He has strong analytical skills and experience using laboratory equipment and systems like HPLC, FTIR, and LIMS. His background includes quality control and manufacturing roles at Johnson & Johnson Vision Care and Regeneron Pharmaceuticals where he was responsible for testing, equipment calibration, batch scheduling, and ensuring compliance.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
Atul Borse has over 4 years of experience in quality control and quality assurance. He has a Master's degree in Analytical Chemistry and is proficient in using instruments like HPLC, GC, FTIR, and UV spectrophotometers. Currently he works as an executive in quality assurance at Johnson & Johnson Ltd. where he handles market complaints and ensures compliance with quality standards. Previously he has worked for other pharmaceutical companies like Wockhardt and Ajanta Pharmaceuticals in roles with increasing responsibility. He is skilled in documentation management, audits, and ensuring compliance with GMP, ISO, and regulatory guidelines.
Joseph Adel Tewfik is seeking a challenging position as a Quality Control or Quality Assurance Manager where he can utilize his 2 years of experience in those roles at ARGO Egypt Plastics. He has a BSC in Chemistry/Zoology from Cairo University and is currently pursuing an MBA. His experience also includes 9 months as a Quality Control Specialist at ARGO Egypt Plastics and 2 years as a Quality Control/Assurance Specialist at EVA Cosmetics SAE.
Ashish Kumar Mishra has over 9 years of experience in quality assurance and operations management. He is currently an Assistant Manager at Cargill India Pvt. Ltd., where he oversees quality assurance operations at three locations. He has expertise in implementing food safety and quality standards like HACCP, ISO 22000, and FSSC 2200. He also has a Green Belt certification in Lean Six Sigma and has received several awards for his work improving processes around recipe accuracy, moisture management, and inventory control.
Pudhucode Krishna Kripesh is seeking a position in quality control or AR&D with 2 years of experience as a chemist in QCP. He has experience with instruments like HPLC, GC, UV spectrometer, and is proficient in methods like moisture analysis, loss on drying, and sulphated ash analysis. He is responsible for laboratory documentation, calibration, and maintenance to ensure compliance with ISO and cGMP standards. Kripesh has strong technical skills and is self-motivated, a quick learner, and able to work independently or as part of a team.
Zeeshan Rashid is seeking a position that allows him to utilize his 5 years of experience in quality control and laboratory analysis. He currently works as a Quality Officer for Pakistan State Oil Company Limited, where he supervises laboratory operations, analyzes petroleum products, maintains documentation systems, and ensures compliance with ISO standards. Rashid has a background in chemistry and business administration, and possesses skills in laboratory instrumentation and management.
Jason Hawkins is an operations manager with over 20 years of experience in manufacturing roles across multiple industries including food and beverage processing, pharmaceuticals, and consumer goods. He has a proven track record of improving safety, quality, and efficiency through initiatives like training programs, process redesigns, and performance management.
This executive profile summarizes the experience of an individual with over 7 years of experience in food product development and laboratory operations. They hold an M.Tech in Food Technology and Biochemical Engineering and have experience leading new product development teams. Their career includes roles developing specialty fat products, validating enzyme applications, and currently serving as a Food Analyst overseeing a laboratory team.
Mkt 1043 stability and efficiency testing-SPPT23DrMariani
Stability testing is performed on cosmetic formulations to ensure they maintain consistent physical, chemical, and performance characteristics over their shelf life under different storage conditions. Key aspects of stability testing covered in the document include:
- Testing formulations at different temperatures and light levels to simulate real-world conditions.
- Evaluating characteristics like color, odor, viscosity, and emulsion stability at intervals.
- Guidelines for when additional testing is needed, such as with new formulations, raw materials, or manufacturing processes.
- Common testing procedures include temperature cycling, centrifugation, and packaging tests.
- The goal is to predict a formulation's stability so consumers receive a consistent product.
This document provides a summary of a dashboard and reflective review presentation from 2019. It discusses various quality topics related to pharmaceutical manufacturing including assay testing of APIs, use of preservatives, microbial limits, process validation, cleaning validation, API testing responsibilities, and more. Key points emphasized include using a risk-based approach to assessing changes and product holds, ensuring sampling methods are scientifically sound, and the importance of evaluating cleaning procedures to maintain ability to clean. Recent regulatory guidance from EMA regarding evaluation of nitrosamines is also summarized.
This document discusses packaging technologies for two case studies - an artisan seafood producer and a smoked meats manufacturer. For the seafood producer, a polypropylene tray with an antifog film top was chosen to withstand pasteurization at 85C for 30 minutes to achieve over 8 days shelf life. A packaging machine costing €27k was selected. For the smoked meats manufacturer considering upgrading packaging, competitor offerings provided inspiration for more visually appealing options that could be automated.
This summary provides an overview of Desiree Bartley's qualifications and experience:
Desiree Bartley has over 10 years of experience in quality control for the pharmaceutical industry, including experience in biotech, consumer health, and cosmetics manufacturing. She has extensive experience in aseptic techniques such as environmental sampling and quality assurance/quality control activities. Bartley also has certifications in cleanroom behavior, aseptic gowning practices and procedures, and ensuring compliance with Good Manufacturing Practices and FDA regulations.
Some of her key roles include serving as an environmental monitoring subject matter expert and trainer at Pfizer in Pearl River, NY, where she performed quality control activities supporting sterile vaccine production for over 13 years.
This document provides an introduction and overview of a training session on Good Manufacturing Practices (GMP) for the 21st century. It notes that the presentation will reflect the presenter's views and is not meant to represent any official policies. Examples of recent drug contamination and mix-ups are presented to illustrate the importance of GMP in ensuring consistent quality, preventing contamination and mix-ups. GMP is described as a set of regulatory methods to inspect manufacturing practices to protect the integrity and quality of products intended for human use and ensure they are consistently produced and controlled.
Deibel Laboratories has been providing food and personal care product testing services for over 30 years through a network of 12 laboratories across the US that operate 365 days a year. They take a partnership approach to working with clients by providing personalized support to help ensure product quality and safety rather than just reporting results. Many food producers and companies trust Deibel Labs for their quality control protocols, scientific integrity, and customer service to protect their brand names.
Vivek Khare is a business specialist and key account executive with over 8 years of experience in sales and marketing of laboratory products. He is currently employed by AVANTOR PERFORMANCE MATERIALS, where he is responsible for sales promotion, order generation, customer interaction and developing new business. Previously he has worked for Merck Specialties and Biocon Health Care in similar roles handling customers in the pharmaceutical, chemical and research industries. He holds an MBA in Marketing and a BSc in Chemistry.
This document provides an introduction and overview of Failure Mode Effect Analysis (FMEA). FMEA is used across several industries including automotive, aerospace, military, and others to analyze potential failures, their causes and effects. The document outlines the steps to conduct an FMEA, including defining the item or process being analyzed, identifying potential failure modes and their causes and effects, analyzing current prevention and detection controls, and determining a risk priority number. It then provides a sample FMEA analysis for purchasing milk for a lactose intolerant child, identifying potential failures from purchasing the wrong milk to packaging issues, and assessing prevention controls, occurrence, detection and severity to calculate risk.
Karen Campbell is seeking a position that utilizes her experience in quality assurance and process improvement. She has over 30 years of experience in medical laboratories and 13 years as Quality Assurance Manager at ThermoFisher Scientific, where she developed quality processes, standard operating procedures, metric boards, and led corrective actions. She is trained in Lean Enterprise techniques and served as an internal ISO auditor.
This document announces two half-day post-conference workshops on May 10, 2017 at the Copthorne Tara Hotel in London. The morning workshop from 8:30-13:00 is on "Getting the most out of DOE approaches during freeze drying development" and will cover fundamentals of lyophilization development and practical advice on design of experiments approaches. The afternoon workshop from 13:30-17:30 is on "Strategies to achieving process transfer in lyophilisation" and will discuss challenges in transferring lyophilization processes. Both workshops will include presentations, discussions, and case studies from industry experts.
Sudeep Killedar is seeking a career enriching role in business development with a focus on the pharmaceutical industry, leveraging his nearly 9 years of experience in production, process enhancement, packaging, and research documentation for well-known pharmaceutical organizations. He has skills in enhancing production operations, optimizing resources, and ensuring compliance with quality standards and regulatory guidelines. The document provides details on his educational background and work experience in various roles with increasing responsibility in the pharmaceutical industry.
Matthew Eric Hulsey is seeking a challenging career opportunity utilizing his manufacturing experience, chemical engineering expertise, and leadership skills. He has over 3 years of experience in manufacturing and operations management roles at Pepsi Beverages Company, where he supervised production lines and led Lean Six Sigma projects. Previously, he completed an internship at Tyco Fire Protection Products where he evaluated fire suppression chemicals and testing procedures. Hulsey holds a Bachelor of Science in Chemical Engineering from the University of Florida and is proficient in various production, sanitation, and computer software.
The candidate has 13 years of experience in quality management spanning supplier quality, production quality, customer service, and after-sales service. They have set up quality management systems from scratch for two companies, achieving ISO 9001 certification immediately for one and with zero non-conformities for the other. Currently, they are working to develop a quality control system for their company by establishing processes and controls to ensure consistent product quality. Key metrics such as customer complaints, reject rates, and returns have significantly improved since controls were implemented.
Michael Riordan is an enthusiastic and motivated lab technician seeking a position that utilizes his experience in pharmaceutical and industrial chemistry. He has strong analytical skills and experience using laboratory equipment and systems like HPLC, FTIR, and LIMS. His background includes quality control and manufacturing roles at Johnson & Johnson Vision Care and Regeneron Pharmaceuticals where he was responsible for testing, equipment calibration, batch scheduling, and ensuring compliance.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
Atul Borse has over 4 years of experience in quality control and quality assurance. He has a Master's degree in Analytical Chemistry and is proficient in using instruments like HPLC, GC, FTIR, and UV spectrophotometers. Currently he works as an executive in quality assurance at Johnson & Johnson Ltd. where he handles market complaints and ensures compliance with quality standards. Previously he has worked for other pharmaceutical companies like Wockhardt and Ajanta Pharmaceuticals in roles with increasing responsibility. He is skilled in documentation management, audits, and ensuring compliance with GMP, ISO, and regulatory guidelines.
Joseph Adel Tewfik is seeking a challenging position as a Quality Control or Quality Assurance Manager where he can utilize his 2 years of experience in those roles at ARGO Egypt Plastics. He has a BSC in Chemistry/Zoology from Cairo University and is currently pursuing an MBA. His experience also includes 9 months as a Quality Control Specialist at ARGO Egypt Plastics and 2 years as a Quality Control/Assurance Specialist at EVA Cosmetics SAE.
Ashish Kumar Mishra has over 9 years of experience in quality assurance and operations management. He is currently an Assistant Manager at Cargill India Pvt. Ltd., where he oversees quality assurance operations at three locations. He has expertise in implementing food safety and quality standards like HACCP, ISO 22000, and FSSC 2200. He also has a Green Belt certification in Lean Six Sigma and has received several awards for his work improving processes around recipe accuracy, moisture management, and inventory control.
Pudhucode Krishna Kripesh is seeking a position in quality control or AR&D with 2 years of experience as a chemist in QCP. He has experience with instruments like HPLC, GC, UV spectrometer, and is proficient in methods like moisture analysis, loss on drying, and sulphated ash analysis. He is responsible for laboratory documentation, calibration, and maintenance to ensure compliance with ISO and cGMP standards. Kripesh has strong technical skills and is self-motivated, a quick learner, and able to work independently or as part of a team.
Zeeshan Rashid is seeking a position that allows him to utilize his 5 years of experience in quality control and laboratory analysis. He currently works as a Quality Officer for Pakistan State Oil Company Limited, where he supervises laboratory operations, analyzes petroleum products, maintains documentation systems, and ensures compliance with ISO standards. Rashid has a background in chemistry and business administration, and possesses skills in laboratory instrumentation and management.
Jason Hawkins is an operations manager with over 20 years of experience in manufacturing roles across multiple industries including food and beverage processing, pharmaceuticals, and consumer goods. He has a proven track record of improving safety, quality, and efficiency through initiatives like training programs, process redesigns, and performance management.
This executive profile summarizes the experience of an individual with over 7 years of experience in food product development and laboratory operations. They hold an M.Tech in Food Technology and Biochemical Engineering and have experience leading new product development teams. Their career includes roles developing specialty fat products, validating enzyme applications, and currently serving as a Food Analyst overseeing a laboratory team.
Mkt 1043 stability and efficiency testing-SPPT23DrMariani
Stability testing is performed on cosmetic formulations to ensure they maintain consistent physical, chemical, and performance characteristics over their shelf life under different storage conditions. Key aspects of stability testing covered in the document include:
- Testing formulations at different temperatures and light levels to simulate real-world conditions.
- Evaluating characteristics like color, odor, viscosity, and emulsion stability at intervals.
- Guidelines for when additional testing is needed, such as with new formulations, raw materials, or manufacturing processes.
- Common testing procedures include temperature cycling, centrifugation, and packaging tests.
- The goal is to predict a formulation's stability so consumers receive a consistent product.
This document provides a summary of a dashboard and reflective review presentation from 2019. It discusses various quality topics related to pharmaceutical manufacturing including assay testing of APIs, use of preservatives, microbial limits, process validation, cleaning validation, API testing responsibilities, and more. Key points emphasized include using a risk-based approach to assessing changes and product holds, ensuring sampling methods are scientifically sound, and the importance of evaluating cleaning procedures to maintain ability to clean. Recent regulatory guidance from EMA regarding evaluation of nitrosamines is also summarized.
Designing an appropriate qc design procedure for your lab 5 mar15Randox
This document discusses the importance of quality control (QC) procedures in laboratories and provides five simple steps for effective QC. It emphasizes that the goal of QC is to ensure accurate and reliable test results in order to avoid harming patients. The five steps include: 1) identifying quality specifications for each test, 2) choosing good quality control materials, 3) starting and ending patient testing with QC evaluation, 4) understanding good QC results, and 5) recognizing and addressing out-of-control events. Participation in an external quality assessment scheme is also recommended to help detect errors. The document stresses applying QC procedures appropriately based on each test's performance and prioritizing high-risk tests.
Designing an appropriate QC procedure for your laboratoryRandox
Improving Laboratory Performance Through Quality Control - Five Simple Steps for QC Success.
It is easy to get caught up in an abundance of QC statistics and forget the fundamental reason why
QC exists in the first instance. QC is about detecting errors and ensuring that the results you
produce are accurate and reliable. All QC procedures should focus on reducing the risk of harm
to the patient. We are not examining statistics; we are examining real patients, real results and real
lives. Around 70% of all medical decisions are based on laboratory results, which is why it is of
utmost importance that each and every laboratory, has a well-designed QC procedure in place.
9-10 CBLM_ComCooking NC III (Edited).docxBobieTinaya2
This document outlines quality control procedures for commercial kitchens. It discusses establishing ingredient specifications, approved supplier lists, product formulations, standards, manufacturing procedures, in-process record keeping, packaging and labeling requirements, good manufacturing practices, warehousing, and laboratory analysis. Maintaining quality control is important at all stages of food production to ensure product safety and consistency.
The document outlines the key stages of product development: 1) Initial ideas are generated through market research or modifying existing products; 2) Test recipes are developed and evaluated informally in a test kitchen; 3) Acceptable products are produced at a pilot plant and evaluated in sensory tests; 4) Final products are tested through consumer testing methods like group discussions, street interviews, and home trials; 5) Successful products then proceed to large-scale manufacturing, a product launch, and later review. Sensory evaluation and consumer feedback are important throughout the process to refine products that will appeal to consumers.
This presentation presents the meaning of product development, the key stages of product development and the importance of research, sensory evaluation and consumer testing.
The document provides a summary of Pramesh Kothari's professional experience and qualifications. It summarizes that he has over 27 years of experience in quality control and management roles in the pharmaceutical industry, including 7 years as Director/General Manager of QC laboratories. He has extensive expertise in analytical techniques and developing, enhancing, and ensuring compliance of quality systems, and has successfully led teams through regulatory audits from the USFDA and other global regulators.
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 provides an overview of maximizing and extending shelf-life for food and beverage products. It discusses best before and use by dates, the steps for setting shelf-life which include establishing product parameters, checking legislation, identifying microorganisms of concern, conducting shelf-life testing, and ongoing review. Extending shelf-life can offer benefits but safety and quality must not be compromised. Considerable expertise is needed to properly set or extend shelf-life to ensure legal compliance and protection of consumers.
Top Tips for Improving your Quality ManagementClaire Healey
An essential guide to assist you, the Quality Expert in enforcing the standards you expect on a daily basis across the whole manufacturing plant. Improve product quality, traceability and Statistical Process Control (SPC) whilst preventing mix-up and product recalls in manufacturing.
Strategies for Improving Auditor Competency on a Global Perspectivededmark
This document discusses strategies for improving auditor competency from a global perspective. It outlines SGS' global capabilities in terms of the number of qualified auditors they have for various certification standards. It emphasizes the importance of training, qualifications, and ongoing development for auditors. Specific strategies proposed include formal education, internal and industry training, participation in professional associations, and feedback processes. Key qualifications for auditors include experience, training, and adherence to standards for impartiality.
The document provides a summary of an individual's experience in quality control and analytical roles in the pharmaceutical industry spanning over 11 years. It includes experience managing quality control testing, method development and validation, documentation, audits, and ensuring compliance with regulatory standards. The individual holds an M.Sc. in Chemistry and has worked in quality control laboratories for several major pharmaceutical companies in India and Oman, taking on roles of increasing responsibility including group leader and assistant manager.
pilot plant is a small system which is operated to find out about the behavior of a process before using it on a large industrial scale. so, this presentation tries to illustrate its objective and significance to understand the methodologies of various pharmaceutical dosage forms.
In this presentation you will find the types of new product,the product development team,product development processes and their phases witch includes
1: Product Definition
2: Product implementation
3: Product Definition
with complete description.
1) GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
2) WHY WAS GLP CREATED? • In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. • They discovered a lot fraudulent activities and a lot of poor lab practices. • Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study. 3. Inadequate test systems.
3) Purpose of GLPs: • GLP is to certify that every step of the analysis is valid or Not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products. • GLPs have heavy emphasis on data recording, record & specimen retention.
4)GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
5) GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
6) "Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.
7 Tips to Manage UAT Testing Process.pdfRiley Claire
User Accessibility Testing is the final stage of the software testing process. This UAT method is significant and critical since it verifies whether all business criteria have been met before releasing the final product. UAT can also refer to the stages of alpha and beta testing, in which a product is broadly distributed to detect flaws in increasingly complex use cases.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Commrcialization is the process of bringing new product to services to market . The broader act of commercializ
Commercialization is the process of bringing new product to services to market. The broader act of commercialization entails production, distribution, marketing, sales, customer support, and other key function critical to achieving the commercial success of the new product or service.
This curriculum vitae summarizes the qualifications and experience of Kelvin R. Abanera. He has a Bachelor of Science in Food Technology degree and over 5 years of experience in quality assurance roles. His most recent role was as Quality Assurance Officer at Phil-Union Frozen Foods, Inc. where he held various positions related to food safety, auditing, pest control, sanitation, shelf-life testing, and documentation control. Prior to that, he worked as a Quality Control Officer at Siegranch Chemicalworks Corporation where he led quality inspection teams and analyzed production processes.
1. Institute of
Personal Care Science
PO Box 995, Coolum Beach, QLD Australia 4573
Ph: (07) 5446 4680 www.personalcarescience.com.au
1
5 Costly Mistakes of Research &
Development
AND HOW TO AVOID THEM!
You’ve got this fantastic sample of product, have approved the formula and are now ready to get
it mass produced. It should turn out fine, right? WRONG!!! Liking the feel or look of that sample is
only one aspect of Research & Development (R&D) – the tip of the iceberg really – because lying
beneath the surface of that product is a multitude of errors that can be made, and come back to
haunt you at a later date.
If something does go wrong, it’s the fault of the formula, right? NOT NECESSARILY!!! There are
certain steps of production and product evaluation that go beyond initial formulation development
that still fall into the scope of ‘R&D’ – but all too often, aren’t carried out effectively, if at all,
because of ‘cost’ - such as extended stability testing and appropriate scale up. Just remember
though, there is nothing cheap about a failed production batch or product recall!
This report looks at 5 Costly Mistakes of R&D that all too commonly occur and tells you how to
avoid them!
Costly Mistake #1: Incorrect preservative selection
The preservatives used in your products would invariably be the most controversial part of the
development – with so much misinformation on the internet about their safety (or potential harm),
and avoidance of certain preservatives by consumers, preservative selection is something your
brand needs to think carefully about. However, incorrect preservative selection is the most
harmful of all!
For example, did you know that different preservatives have different selection criteria based on:
form of the finished product
pH of the finished product, and likely pH drift over time
application of the finished product, i.e. the age of the user, how often they will be using it,
where they will be using it, whether it will be left on or washed off
certification requirements of the finished product
required smell, feel and look of the finished product
the country or countries the products will be sold in
Despite common internet misconceptions, the preservatives that are permitted by regulatory
authorities in personal care products, when selected and used correctly, are SAFE when used
within the stated limits – but this doesn’t necessarily mean they will suit your company
philosophy!
Formulators are responsible to ensure theoretical efficacy of the preservatives they use in your
products after taking into consideration all required selection criteria. True guarantees of
effectiveness, however, can only be confirmed by Preservative Efficacy Testing (PET or
Challenge Testing). Even then, things can and do go wrong during scale up or bulk production
that may cause a preservative to fail – but when product is adequately tested before being
released for sale, preventing contaminated product from entering the market place is largely
avoidable, and prevents one of the most common costly mistakes that occurs in the personal care
industry.
2. Institute of
Personal Care Science
PO Box 995, Coolum Beach, QLD Australia 4573
Ph: (07) 5446 4680 www.personalcarescience.com.au
2
Costly Mistake #2: Ingredient incompatibilities
Not all ingredients are compatible with other ingredients, and this goes far beyond the standard
water hates oil concept! For example, did you know:
certain active ingredients are only compatible within very specific pH limits, and this
varies depending on the type of preparation it is?
various gums and thickeners are not compatible with certain pH levels, in the presence of
charged compounds and have very specific processing requirements to be effective?
the pH required by your preservative can inactivate the performance of other ingredients,
and vice versa?
some emulsifiers have charge, form and ingredient incompatibilities depending on how
they are used and what they are used in conjunction with?
the polarity of lipids can affect product stability, particularly when certain combinations of
lipid soluble actives, performance enhancers or aesthetic agents are used?
Not checking (and double checking) ingredient compatibilities can lead to rapid instability of the
finished product and greatly reduce or negate product performance and aesthetic aspects.
Knowing how to check for ingredient incompatibilities and formulate around these issues is the
only way to ensure theoretical best formulation practice.
Even when the best theoretical development has been conducted, there is nothing like extended
stability testing to confirm suitability.
Costly Mistake #3: Inefficient development time
Investing in R&D is an investment in your brands future – but this doesn’t mean you need to
throw good money after bad in your quest for the next big thing! Have you:
set a realistic budget for formulation development?
considered the costs of additional testing that should be conducted e.g. stability and
PET?
budgeted for the costs of appropriate regulatory checks?
allowed for the costs of pilot and up-scale batches?
worked with your development team to ensure cost- and time-saving efficiencies?
All too often, realistic budgets are not set or adhered to, leading to unrealistic expectations or
unexpected costs! Good formulation principles result in more efficient development time and far
better sample outcomes. Knowing how to formulate correctly and completely leads to faster turn-
around times on samples – saving your company time and money!
Essential elements such as stability, regulatory and scale up steps are commonly not budgeted
for or left out because inefficient development has already broken the budget – but not confirming
stability, not ensuring compliance and not completing necessary scale up steps can lead to failed
batches and product recalls – the costs of which far, FAR exceed having completed these steps
in the first place.
Save on inefficient development time using good formulation principles and invest those savings
into other areas of R&D that often get left out. The result – cost savings AND thorough R&D
which potentially prevents costly mistakes from happening!
3. Institute of
Personal Care Science
PO Box 995, Coolum Beach, QLD Australia 4573
Ph: (07) 5446 4680 www.personalcarescience.com.au
3
Costly Mistake #4: Inadequate scale up procedures
Scale up is the process of taking a formulation from the lab bench to production equipment and
checking it at various sizes of production to ensure its suitability for larger scale equipment. If a
formula fails on larger equipment, it is usually a manufacturing problem, not a formulation
problem – so prevent the problem by performing appropriate scale up.
It is foolish to think that a sample produced in a lab in a 200g or even 1kg sample will turn out the
same if you go straight to producing 100kg. Instead, 10 – 20x increments of scale up is the MOST
that should be used at a time to limit or potentially prevent things from going wrong. For example,
this means:
preparing a 1 – 4kg ‘lab batch’ after a 200g lab sample/formula has been approved – in
many cases, you can use this larger lab batch to start your stability study, so it is never
wasted
preparing a 10 – 20kg ‘pilot batch’ using similar equipment to that which will be used to
produce the full production batch to confirm its suitability when scaling up from the lab
into production equipment – this batch can normally be sold albeit will cost more per kilo
than the full production batch
proceeding to the full 100 – 200kg production batch once the pilot has passed quality
checks and been signed off as suitable
scaling up again if 1000kg or more is required
Not performing appropriate scale up is one of the most preventable costly mistakes of R&D –
don’t fall victim to a failed batch simply because you tried to save time and money by skipping
good scale up procedures!
Costly Mistake #5: Insufficient stability testing
Your formulator is responsible for ensuring good ingredient selection, formulation development
and theoretical stability – but the ONLY way to confirm this is to run longer term accelerated and
real time stability studies. If you want to sell product in Europe, stability programs are essential!
The ONLY way you can confirm the true shelf life of a product is to store it at the temperature
stated on the pack for the duration of the shelf life e.g. 30 months at 25°C. But you don’t want to
have to wait 30 months before you start selling product, so accelerated programs provide relative
confidence as to the product achieving the required shelf life without having to wait too long to
start production.
An effective stability program should include:
preliminary accelerated testing of at least 3 - 6 months on large lab batches before
proceeding to pilot (these results can also be extended to 9-12 months accelerated and
30-36 months real time and be used to support full scale production batch shelf life)
full accelerated and real time stability on the pilot and full production batch
ongoing accelerated and real time stability is also required for therapeutic goods
Brands releasing personal care and cosmetic products all too often think PET is the same as
stability testing or that a 2 week indication of how a product performs under different temperature
conditions is sufficient to proceed to full scale production… but it’s not! If that product separates,
develops off notes over time or otherwise becomes unsuitable to sell due to aesthetics or safety
reasons, a recall will be necessary. There is only one way to be sure your product is suitable to
sell over a 1, 2 or 3 year period and comply with EU requirements. Remove the risk, comply with
the requirements, and know what to expect by conducting appropriate stability testing or have
experts do it for you.
4. Institute of
Personal Care Science
PO Box 995, Coolum Beach, QLD Australia 4573
Ph: (07) 5446 4680 www.personalcarescience.com.au
4
WANT TO LEARN HOW TO GET IT RIGHT?
Want to improve your skills and knowledge as a:
Cosmetic Formulator,
Brand Manager, or
Regulatory Affairs Associate?
Study with the Institute of Personal Care Science – we have a range of Formulating, Brand
Management and Regulatory Diplomas, Certificates, short courses and workshops that can see
you comprehensively trained and/or rapidly up-skilled in key areas, all from the convenience of
a time and place that suits you with:
All distance (on-line) study
1-on-1 tutorial support via skype or phone with our trainers
Flexible study options – study full time, part time or very part time – from as
little as 5-6 hours per week!
Instalment payment options – monthly instalments to help make study
affordable
ALL STUDY IS ON-LINE VIA DISTANCE EDUCATION – study at a time and place that suits you,
anywhere in the world!
With 1-on-1 tutorial support throughout the study period if required and flexible study and
payment options, there has never been a better time to upgrade your skills and knowledge!
Take a look at our YouTube videos on various courses to see what you get when studying with
IPCS:
Formulation courses:
• Diploma of Personal Care Formulation: https://youtu.be/gSyt6wnVVAQ
• Certificate in Advanced Cosmetic Science: https://youtu.be/KpENGIw6bFc
• Certificate in Beginners Cosmetic Science: https://youtu.be/_RPITpWG3PI
• Certificate in Organic Formulations: https://youtu.be/YKBKcD1Wyjg
• Certificate in Colour Cosmetics Formulation: https://youtu.be/8qRAk3obwMc
Brand Management courses:
• Diploma of Personal Care Development & Promotion: https://youtu.be/5flTooGcuR8
• Certificate in Cosmetic Brand Management: https://youtu.be/wVsYcl0Og6Q
Regulatory compliance courses:
• Diploma of Regulatory Compliance: https://youtu.be/iZKetrE8hrA
• Certificate in Cosmetic Regulatory Essentials:
http://personalcarescience.com.au/certificate-cosmetic-regulatory-essentials/
• Certificate in EU compliance: http://personalcarescience.com.au/certificate-eu-
compliance/
Contact us for more information to get the learning and answers you are
searching for no matter where you are located in the world!
info@personalcarescience.com.au
or visit www.personalcarescience.com.au