SoliPharma LLC is a pharmaceutical contract research organization specializing in solid drug development, pre-formulation, formulation, and commercialization services. Based in Delaware with major labs in Hangzhou BioHub, China, it provides analytical testing, solid form studies, crystallization development, formulation development, and other services to pharmaceutical and biotech clients globally. SoliPharma aims to ensure high quality research and potential intellectual property value for its clients.
The document discusses aspects of product design for compounded pharmaceuticals. It outlines differences between industrial and pharmacy compounding in terms of development characteristics and regulatory environment. It emphasizes applying a quality by design approach to development through understanding a product's intended use and performance. A case study describes developing a ready-to-administer bupivacaine-sufentanil solution to improve post-operative analgesia safety.
Nextar is an outsourcing company located in Israel that provides integrated contract drug development and manufacturing services. They have over 35 employees working in state-of-the-art laboratories and clean rooms. Nextar has cGMP, GLP, ISO 13485, and ISO 9001 certifications. Their services include formulation development, analytical testing, custom chemical synthesis, and GMP manufacturing for clinical trials. They have successfully completed over 570 projects for 120 customers.
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
VxP Pharma provides pharmaceutical development services and technical support for developing and producing pharmaceuticals, diagnostics, and drug-device combination products. It offers services across discovery, development, preclinical testing, formulation, manufacturing, and commercialization. VxP differentiates itself by having dedicated subject matter experts that focus on specific areas of development rather than generalists assigned to projects.
Stability indicating analytical method development and validation for estimat...SriramNagarajan18
Stability indicating analytical method development and validation for estimation of Ceftazidime and Avibactam in bulk and pharmaceutical dosage form using RP-HPLC
IRISYS is a pharmaceutical contract development and manufacturing organization founded in 1996 that offers services from preclinical formulation development through commercial manufacturing. It has extensive experience working with a wide range of clients, including small biotechs and large pharmaceutical companies. IRISYS has state-of-the-art facilities inspected by the FDA and is compliant with cGMP regulations. It has expertise in developing formulations across multiple dosage forms and technologies to meet various drug properties and delivery objectives.
The document outlines key aspects of analytical quality by design for pharmaceutical methods and products. It discusses analytical method classifications, parameters for validation, terminology, and international guidelines. Quality by design aims to minimize variability and improve quality through understanding sources of error, selectivity, method transfers, and controlling critical method parameters.
SoliPharma LLC is a pharmaceutical contract research organization specializing in solid drug development, pre-formulation, formulation, and commercialization services. Based in Delaware with major labs in Hangzhou BioHub, China, it provides analytical testing, solid form studies, crystallization development, formulation development, and other services to pharmaceutical and biotech clients globally. SoliPharma aims to ensure high quality research and potential intellectual property value for its clients.
The document discusses aspects of product design for compounded pharmaceuticals. It outlines differences between industrial and pharmacy compounding in terms of development characteristics and regulatory environment. It emphasizes applying a quality by design approach to development through understanding a product's intended use and performance. A case study describes developing a ready-to-administer bupivacaine-sufentanil solution to improve post-operative analgesia safety.
Nextar is an outsourcing company located in Israel that provides integrated contract drug development and manufacturing services. They have over 35 employees working in state-of-the-art laboratories and clean rooms. Nextar has cGMP, GLP, ISO 13485, and ISO 9001 certifications. Their services include formulation development, analytical testing, custom chemical synthesis, and GMP manufacturing for clinical trials. They have successfully completed over 570 projects for 120 customers.
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
VxP Pharma provides pharmaceutical development services and technical support for developing and producing pharmaceuticals, diagnostics, and drug-device combination products. It offers services across discovery, development, preclinical testing, formulation, manufacturing, and commercialization. VxP differentiates itself by having dedicated subject matter experts that focus on specific areas of development rather than generalists assigned to projects.
Stability indicating analytical method development and validation for estimat...SriramNagarajan18
Stability indicating analytical method development and validation for estimation of Ceftazidime and Avibactam in bulk and pharmaceutical dosage form using RP-HPLC
IRISYS is a pharmaceutical contract development and manufacturing organization founded in 1996 that offers services from preclinical formulation development through commercial manufacturing. It has extensive experience working with a wide range of clients, including small biotechs and large pharmaceutical companies. IRISYS has state-of-the-art facilities inspected by the FDA and is compliant with cGMP regulations. It has expertise in developing formulations across multiple dosage forms and technologies to meet various drug properties and delivery objectives.
The document outlines key aspects of analytical quality by design for pharmaceutical methods and products. It discusses analytical method classifications, parameters for validation, terminology, and international guidelines. Quality by design aims to minimize variability and improve quality through understanding sources of error, selectivity, method transfers, and controlling critical method parameters.
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMAT...Earthjournal Publisher
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TERCONAZOLE
Gandhi Santosh V , Phalke Truprti R, Chaudhari Atul P
IRO INTERNATIONAL JOURNAL OF MEDICAL AND APPLIED SCIENCES 2018, 1(1):14-19.
PDF
Impurities ICH Q3 Guidelines Au Vivek JainVivek Jain
This document provides an overview of ICH Q3 guidelines for impurities in pharmaceutical products. It defines impurities and discusses the objectives of controlling impurities. It describes different types of impurities including organic, inorganic, and residual solvents. It outlines ICH Q3A-Q3D guidelines and definitions related to impurities and degradation products. It also discusses thresholds for identifying, reporting, and qualifying degradation products in new drug products.
Formurex is a contract research organization that provides drug formulation development services, analytical testing, GMP manufacturing, and stability studies to support clinical trials for pharmaceutical companies. Its mission is to advance medicine using cutting-edge drug formulation and delivery technologies. Services include preformulation studies, formulation development through various processes like granulation and coating, analytical testing through methods like HPLC and dissolution, and GMP manufacturing of tablets and capsules to support early-stage clinical trials.
The document summarizes the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidelines. The ICH brings together regulatory authorities and the pharmaceutical industry to discuss drug registration. The quality guidelines cover topics such as stability testing, validation of analytical procedures, impurities, pharmacopoeias, quality of biotechnological products, specifications, good manufacturing practices, pharmaceutical development, quality risk management, and the pharmaceutical quality system.
This document provides an overview of Quality by Design (QbD) in pharmaceutical formulation development. It discusses the stages of QbD which include setting formulation objectives, prioritizing input variables for optimization, design guided experimentation and analysis, validation of the QbD methodology, and scale up and production. The benefits of QbD include high quality products, cost savings, reduced rejects, and ease of regulatory approval. Key aspects of QbD include understanding the drug, excipients, processing, and identifying critical quality attributes.
Stability Indicating HPLC Method Development A Reviewijtsrd
High performance liquid chromatography HPLC is an essential analytical tool for evaluating drug stability. HPLC methods must be able to isolate, detect, and quantify drug related degradation products that may form during storage or production, and identify drug related impurities that may form during synthesis. .. This article describes strategies and challenges for designing HPLC methods to demonstrate drug stability. It will deepen our understanding of drugs and medicinal chemistry and demonstrate advances in stability that reflect an analytical approach. Several important chromatographic parameters were investigated to improve the detection of potentially related degradants. It is necessary to find suitable solvent and mobile phase samples that provide sufficient stability and compatibility with each component and potential impurities and degradants. This method should be carefully considered as it has the ability to distinguish between primary and secondary decomposers. The study of forced destruction of chemicals and new drugs is essential for the development and characterization of these immobilization methods. Practical guidance is provided at each stage of drug development to develop a forced disposal protocol and avoid common issues that might impede data interpretation. Suraj Nagwanshi | Smita Aher | Rishikesh Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-5 , August 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46310.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/46310/stability-indicating-hplc-method-development--a-review/suraj-nagwanshi
The document discusses the International Conference on Harmonization (ICH) and its guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration internationally to ensure safe, effective, and high-quality medicines are developed efficiently. The guidelines are divided into four categories: Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M). Some examples of topics covered include stability testing, impurities, clinical trials, good clinical practice, and electronic standards for regulatory information. The overall goal is to increase international cooperation and reduce redundant testing.
The International Conference on Harmonisation (ICH) was created in 1990 as a unique effort between regulators and industry from the EU, Japan, and US to harmonize technical requirements for pharmaceutical registration. ICH aims to ensure safety, efficacy, and quality of medicines while preventing duplicative trials and minimizing animal testing. Through guidelines developed via consensus building among members, ICH has harmonized requirements for drug development and approval processes. However, some concerns remain regarding inclusion of non-members in the decision making and implications for developing countries.
This document describes the formulation, optimization, and evaluation of liquisolid tablets containing tadalafil to improve its bioavailability. Tadalafil was selected as a model drug due to its low water solubility. Several liquisolid formulations were prepared containing different ratios of carrier to coating materials in the powder substrate and a fixed liquid medication. The dissolution profiles of the liquisolid tablets were determined and compared to a commercial product. Prepared liquisolid tablets showed enhanced dissolution profiles compared to the commercial product, indicating improved bioavailability. The optimized formulation exhibited consistent performance over stability testing. Overall, the liquisolid technique improved the dissolution and predicted bioavailability of tadalafil tablets.
This document provides guidance for registration applications on reporting and controlling degradation products in new drug products. Any degradation product observed above the identification threshold in stability studies should be identified. Analytical procedures must be validated to detect and quantify degradation products. Results should be reported for batches used in testing and batches representative of the commercial process. Degradation products present below identification thresholds usually do not need identification, unless they are unusually potent or toxic.
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
This document contains a summary of Mehul D. Patel's work experience and qualifications. It lists his current role as a Research Associate at Torrent Pharmacuticles Ltd since 2006, where he conducts bioanalytical activities and drug metabolism/pharmacokinetics research. Previously he worked as a Research Associate at CADILA Pharmaceutical Ltd from 2005-2006 developing and validating analytical methods. He has a M.Pharm in Pharmacology and B.Pharm degree, and has over 15 years of experience in bioanalytical method development and validation using LC-MS/MS and HPLC techniques.
Generic Drugs; Comparative Dissolution Profile & Discriminative Method for Di...Obaid Ali / Roohi B. Obaid
The document discusses generic drugs and dissolution testing. It notes that some generic products pass dissolution testing using their own methods but fail comparative dissolution testing against innovator products in different pH mediums. Proper dissolution method development is important to demonstrate a method's ability to detect manufacturing variations. The document emphasizes that generic drugs should show similar dissolution profiles to innovator products in different pH environments to help ensure similar clinical responses. It also stresses the importance of methods being able to discriminate between formulations and catch impacts of manufacturing changes.
The document discusses pharmaceutical product development and regulation. It addresses what information a regulatory authority would need to see if someone claims to have discovered a new drug or developed a generic version of an existing drug. It explains the importance of absorption and bioavailability/bioequivalence testing. It also presents scenarios about an innovator changing a drug's formulation, manufacturing site, process, or equipment and asks what type of studies would be required. The overall message is that understanding a product, controlling the manufacturing process, and demonstrating consistent quality and therapeutic effect through clinical and comparative dissolution studies are crucial aspects of drug regulation.
The International Conference on Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss drug registration. ICH has evolved to address increasingly global drug development. It consists of quality, safety, efficacy, and multidisciplinary guidelines. The quality guidelines cover topics like stability testing, impurities, good manufacturing practices, pharmaceutical development, quality risk management, and more. Adoption of these guidelines promotes harmonization and innovation in drug development and manufacturing on a global scale.
This document outlines the structure and process of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH aims to harmonize technical guidelines for pharmaceutical drug development and registration among Europe, Japan, and the United States. It discusses the objectives and five steps of the ICH process, and provides examples of guidelines produced on quality, safety, efficacy, and multidisciplinary topics.
The document provides an overview of ICH guidelines, including:
- ICH was created in 1990 to harmonize technical requirements for drug approval between Europe, Japan, and the US.
- ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics.
- Quality (Q) guidelines cover stability testing, validation, impurities, specifications, and CGMPs.
- The document focuses on Q guidelines for stability, impurities, specifications, and biotechnology products.
This document discusses different types of packaging and potential interactions between packaging materials and drugs. It identifies three types of packaging: primary, secondary, and tertiary. It then explains processes like sorption, leaching, permeation, and interaction with metals that can cause drugs or excipients to be absorbed or migrate from packaging materials. Several examples are provided of specific packaging materials that are incompatible with certain drugs or excipients due to absorption or chemical interactions. Finally, it lists factors that influence these interactions and analytical techniques used to examine them.
The document summarizes a New Zealand workshop discussing opportunities for linking business clusters in India and New Zealand. It outlines the agenda which includes introductions, examples of dairy and wool cluster interactions between the two countries, and a discussion on future potential cluster linkages. Examples provided include opportunities in the aviation, technology, building products, healthcare and other industries. The workshop aims to identify ways for large New Zealand clusters to partner with related small clusters in India to create international business opportunities.
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMAT...Earthjournal Publisher
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TERCONAZOLE
Gandhi Santosh V , Phalke Truprti R, Chaudhari Atul P
IRO INTERNATIONAL JOURNAL OF MEDICAL AND APPLIED SCIENCES 2018, 1(1):14-19.
PDF
Impurities ICH Q3 Guidelines Au Vivek JainVivek Jain
This document provides an overview of ICH Q3 guidelines for impurities in pharmaceutical products. It defines impurities and discusses the objectives of controlling impurities. It describes different types of impurities including organic, inorganic, and residual solvents. It outlines ICH Q3A-Q3D guidelines and definitions related to impurities and degradation products. It also discusses thresholds for identifying, reporting, and qualifying degradation products in new drug products.
Formurex is a contract research organization that provides drug formulation development services, analytical testing, GMP manufacturing, and stability studies to support clinical trials for pharmaceutical companies. Its mission is to advance medicine using cutting-edge drug formulation and delivery technologies. Services include preformulation studies, formulation development through various processes like granulation and coating, analytical testing through methods like HPLC and dissolution, and GMP manufacturing of tablets and capsules to support early-stage clinical trials.
The document summarizes the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidelines. The ICH brings together regulatory authorities and the pharmaceutical industry to discuss drug registration. The quality guidelines cover topics such as stability testing, validation of analytical procedures, impurities, pharmacopoeias, quality of biotechnological products, specifications, good manufacturing practices, pharmaceutical development, quality risk management, and the pharmaceutical quality system.
This document provides an overview of Quality by Design (QbD) in pharmaceutical formulation development. It discusses the stages of QbD which include setting formulation objectives, prioritizing input variables for optimization, design guided experimentation and analysis, validation of the QbD methodology, and scale up and production. The benefits of QbD include high quality products, cost savings, reduced rejects, and ease of regulatory approval. Key aspects of QbD include understanding the drug, excipients, processing, and identifying critical quality attributes.
Stability Indicating HPLC Method Development A Reviewijtsrd
High performance liquid chromatography HPLC is an essential analytical tool for evaluating drug stability. HPLC methods must be able to isolate, detect, and quantify drug related degradation products that may form during storage or production, and identify drug related impurities that may form during synthesis. .. This article describes strategies and challenges for designing HPLC methods to demonstrate drug stability. It will deepen our understanding of drugs and medicinal chemistry and demonstrate advances in stability that reflect an analytical approach. Several important chromatographic parameters were investigated to improve the detection of potentially related degradants. It is necessary to find suitable solvent and mobile phase samples that provide sufficient stability and compatibility with each component and potential impurities and degradants. This method should be carefully considered as it has the ability to distinguish between primary and secondary decomposers. The study of forced destruction of chemicals and new drugs is essential for the development and characterization of these immobilization methods. Practical guidance is provided at each stage of drug development to develop a forced disposal protocol and avoid common issues that might impede data interpretation. Suraj Nagwanshi | Smita Aher | Rishikesh Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-5 , August 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46310.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/46310/stability-indicating-hplc-method-development--a-review/suraj-nagwanshi
The document discusses the International Conference on Harmonization (ICH) and its guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration internationally to ensure safe, effective, and high-quality medicines are developed efficiently. The guidelines are divided into four categories: Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M). Some examples of topics covered include stability testing, impurities, clinical trials, good clinical practice, and electronic standards for regulatory information. The overall goal is to increase international cooperation and reduce redundant testing.
The International Conference on Harmonisation (ICH) was created in 1990 as a unique effort between regulators and industry from the EU, Japan, and US to harmonize technical requirements for pharmaceutical registration. ICH aims to ensure safety, efficacy, and quality of medicines while preventing duplicative trials and minimizing animal testing. Through guidelines developed via consensus building among members, ICH has harmonized requirements for drug development and approval processes. However, some concerns remain regarding inclusion of non-members in the decision making and implications for developing countries.
This document describes the formulation, optimization, and evaluation of liquisolid tablets containing tadalafil to improve its bioavailability. Tadalafil was selected as a model drug due to its low water solubility. Several liquisolid formulations were prepared containing different ratios of carrier to coating materials in the powder substrate and a fixed liquid medication. The dissolution profiles of the liquisolid tablets were determined and compared to a commercial product. Prepared liquisolid tablets showed enhanced dissolution profiles compared to the commercial product, indicating improved bioavailability. The optimized formulation exhibited consistent performance over stability testing. Overall, the liquisolid technique improved the dissolution and predicted bioavailability of tadalafil tablets.
This document provides guidance for registration applications on reporting and controlling degradation products in new drug products. Any degradation product observed above the identification threshold in stability studies should be identified. Analytical procedures must be validated to detect and quantify degradation products. Results should be reported for batches used in testing and batches representative of the commercial process. Degradation products present below identification thresholds usually do not need identification, unless they are unusually potent or toxic.
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
This document contains a summary of Mehul D. Patel's work experience and qualifications. It lists his current role as a Research Associate at Torrent Pharmacuticles Ltd since 2006, where he conducts bioanalytical activities and drug metabolism/pharmacokinetics research. Previously he worked as a Research Associate at CADILA Pharmaceutical Ltd from 2005-2006 developing and validating analytical methods. He has a M.Pharm in Pharmacology and B.Pharm degree, and has over 15 years of experience in bioanalytical method development and validation using LC-MS/MS and HPLC techniques.
Generic Drugs; Comparative Dissolution Profile & Discriminative Method for Di...Obaid Ali / Roohi B. Obaid
The document discusses generic drugs and dissolution testing. It notes that some generic products pass dissolution testing using their own methods but fail comparative dissolution testing against innovator products in different pH mediums. Proper dissolution method development is important to demonstrate a method's ability to detect manufacturing variations. The document emphasizes that generic drugs should show similar dissolution profiles to innovator products in different pH environments to help ensure similar clinical responses. It also stresses the importance of methods being able to discriminate between formulations and catch impacts of manufacturing changes.
The document discusses pharmaceutical product development and regulation. It addresses what information a regulatory authority would need to see if someone claims to have discovered a new drug or developed a generic version of an existing drug. It explains the importance of absorption and bioavailability/bioequivalence testing. It also presents scenarios about an innovator changing a drug's formulation, manufacturing site, process, or equipment and asks what type of studies would be required. The overall message is that understanding a product, controlling the manufacturing process, and demonstrating consistent quality and therapeutic effect through clinical and comparative dissolution studies are crucial aspects of drug regulation.
The International Conference on Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss drug registration. ICH has evolved to address increasingly global drug development. It consists of quality, safety, efficacy, and multidisciplinary guidelines. The quality guidelines cover topics like stability testing, impurities, good manufacturing practices, pharmaceutical development, quality risk management, and more. Adoption of these guidelines promotes harmonization and innovation in drug development and manufacturing on a global scale.
This document outlines the structure and process of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH aims to harmonize technical guidelines for pharmaceutical drug development and registration among Europe, Japan, and the United States. It discusses the objectives and five steps of the ICH process, and provides examples of guidelines produced on quality, safety, efficacy, and multidisciplinary topics.
The document provides an overview of ICH guidelines, including:
- ICH was created in 1990 to harmonize technical requirements for drug approval between Europe, Japan, and the US.
- ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics.
- Quality (Q) guidelines cover stability testing, validation, impurities, specifications, and CGMPs.
- The document focuses on Q guidelines for stability, impurities, specifications, and biotechnology products.
This document discusses different types of packaging and potential interactions between packaging materials and drugs. It identifies three types of packaging: primary, secondary, and tertiary. It then explains processes like sorption, leaching, permeation, and interaction with metals that can cause drugs or excipients to be absorbed or migrate from packaging materials. Several examples are provided of specific packaging materials that are incompatible with certain drugs or excipients due to absorption or chemical interactions. Finally, it lists factors that influence these interactions and analytical techniques used to examine them.
The document summarizes a New Zealand workshop discussing opportunities for linking business clusters in India and New Zealand. It outlines the agenda which includes introductions, examples of dairy and wool cluster interactions between the two countries, and a discussion on future potential cluster linkages. Examples provided include opportunities in the aviation, technology, building products, healthcare and other industries. The workshop aims to identify ways for large New Zealand clusters to partner with related small clusters in India to create international business opportunities.
Wonder why social media is suddenly such a hot commodity? Wish you knew how the most popular platforms worked, and what kinds of communities they created? Curious about how you can use social media for business, or even in an Advanced Writing classroom? You're in the right place.
Capsugel, the global leader in capsule manufacturing, needed to entice their customers with a broad range of capabilities. By simplifying the message and adding a new tag line, I brought a sense of lightheartedness and unity to the ad.
Liberalization of economies across the globe has brought packaging technology to the forefront. Packaging being pervasive, in today’s business plays an important role and each member in the supply chain looks forward ‘to use packaging as a strategic tool for business development and improved business performance 1 under the present and future needs’.
As pharmaceutical and biopharmaceutical companies increase their levels of external development and manufacturing, the need for unbiased information to support strategic business decisions continues to grow. In this report, ISR provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 26 performance attributes specific to drug product manufacturing projects. In this Consumer Reports-style analysis, ISR presents data on 423 service encounters from 217 respondents who have been involved in outsourced fill finish projects in the past 18 months.
Pfizer is a global pharmaceutical company with over $71 billion in combined revenue. It has over 100,000 employees working in over 150 countries. Pfizer has a diverse portfolio of over 60 products generating over $100 million in sales each and 16 products generating over $1 billion in sales. It focuses on key disease areas like neuroscience, oncology, and infectious diseases. Pfizer has a large research and development pipeline with over 600 projects in development and registration stages between its own pipeline and projects from its acquisition of Wyeth. Pfizer offers opportunities for challenging work and continuous learning for motivated individuals as part of its mission to improve health worldwide.
This document discusses anti-counterfeiting packaging. It begins by defining counterfeit drugs and products and providing statistics on the counterfeit drug industry. It then discusses the health and economic risks of counterfeit drugs. The document outlines various anti-counterfeiting technologies including overt features like holograms, covert features like microprinting, and track and trace technologies like serialization. It provides examples of different anti-counterfeiting packaging technologies and discusses their purpose in verifying authenticity and preventing counterfeiting.
This document discusses packaging materials for pharmaceutical products. It begins by outlining factors to consider when selecting packaging, such as the product's characteristics, protective needs, and marketing requirements. It then describes the necessary characteristics of packaging materials, including protecting the product from environmental conditions while meeting regulations. The document categorizes packaging as primary, secondary, tertiary, or ancillary. It provides examples of materials used for different pharmaceutical dosage forms and packaging levels. Finally, it discusses quality control testing and tamper-resistant packaging options.
The document discusses clusters in India, including their size, geographical distribution, and major characteristics. It notes that there are over 1,200 clusters in India covering 321 products, which collectively account for approximately 30% of total manufacturing output. The largest clusters are located in the northern, western, and southern regions of India. Common characteristics of Indian clusters include historically evolving over time, flexibility to meet demand, focus on the domestic market, high levels of subcontracting, and defined boundaries. The document also provides examples of prominent Indian clusters and assesses their competitiveness using a diamond model analysis framework.
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
The document discusses automation in pharmaceutical packaging. It describes how automation can be incorporated into various stages of packaging, from internal machine controls to full integration with enterprise resource planning systems. Key aspects of automation discussed include bottle orientation, capping, labeling, collation, bar code tracking, robotics, machine vision, and laser printing. Automation benefits pharmaceutical packaging by increasing productivity, quality assurance, and traceability of the packaging process.
The Indian nutraceuticals market was estimated to be worth $2 billion in 2010 and is expected to reach $5 billion by 2015. Functional foods and beverages are predicted to experience stronger growth than dietary supplements. Diabetic functional foods and enhanced drinks and energy beverages are anticipated to see particularly high demand. Vitamin and mineral supplements currently dominate the market but interest in herbal supplements is growing. Major players operating in the Indian nutraceuticals space include Dabur, Dr. Reddy's, and Amway, with new companies also entering the market.
Umang pharmaceutical packaging..b.k.mody goverment pharmacy college rajkotumang971991
This document discusses various aspects of pharmaceutical packaging including primary, secondary and tertiary packaging. It describes different types of materials used for packaging like glass, plastics, metals, rubber and closures. Glass containers discussed include types I, II, III and NP glass. Common plastics used are polyethylene, polyvinyl chloride, polymethyl methacrylate and polypropylene. Factors to consider for drug-plastic compatibility and different types of closures are also summarized.
This was presented to a group of county commissioners and county judges to provide them the pros and cons of social media. The goal was to show them the benefits of using it to reach customers in the county, especially by state extension agents.
Dabur India is the 4th largest FMCG company in India with over 130 years of history. It has strategic business units in healthcare, personal care, and food products with a turnover of INR 7,800 crore in 2014-15. Dabur markets its ayurvedic and herbal products in over 100 countries and is the leader in herbal digestives with 90% market share. Its product portfolio includes hair care, oral care, skin care, foods, ayurvedic health products, and pharmaceuticals. Dabur continues to innovate, expand into new categories and markets, and faces competition from other FMCG and medical companies.
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
Diteba is a cGMP/GLP pharmaceutical laboratory located near Toronto, Canada that offers analytical R&D services including method development and validation, bioanalytical testing, quality control release testing, stability testing, and in vitro release testing. The company has over 10,000 square feet of laboratory space equipped with state-of-the-art instrumentation. Diteba's team of senior scientists have extensive experience across various therapeutic areas and analytical techniques.
Penn Pharma provides pharmaceutical development, manufacturing, packaging, and consulting services. Their capabilities include formulation development, analytical testing, clinical trial supply, commercial manufacturing, and QP certification. They have facilities for tablets, capsules, liquids, and other dosage forms. Penn Pharma offers a full range of integrated services to support customers from pre-clinical development through commercialization.
Presentation given by Laurène Haurie from Plateforme Gala in the framework of the Emergence Forum Barcelona
Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation.
More information at: http://www.b2match.eu/emergenceforum2014
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
Pharmaceutical Product development technologyUmang Budhraja
Umang Pharmatech Pvt. Ltd. offers various controlled release technologies including controlled release pellets, gelatin beads using hot melt extrusion, mouth dissolving films, and micro pellets. They provide formulation development, analytical testing, stability studies, regulatory dossier preparation, and contract manufacturing services. Their technologies can be used to develop various release profiles including extended, sustained, delayed, and enteric release formulations.
Sandra Ibarrondo is seeking a position utilizing her skills in analytical chemistry and quality control. She has over 20 years of experience in analytical instrumentation including HPLC, GC, AA, TOC, and UV/Vis spectrophotometry. Her background includes method development and validation, laboratory supervision, and ensuring compliance with FDA regulations and cGMP. She is proficient in various chromatography data systems and has experience reviewing laboratory data and documentation.
CoreRx is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
CoreRx is a dosage form development company specializing in preformulation, formulation development, analytical development, clinical manufacturing, and commercial manufacturing. It has experienced professionals and state-of-the-art facilities. CoreRx focuses on client satisfaction through effective communication, flexibility, speed, and high quality systems. It offers a range of services from preformulation to stability studies to meet clients' drug development needs.
This document provides an overview of pharmaceutical development based on the ICH Q8(R2) guideline. It discusses key concepts like the quality target product profile, critical quality attributes, risk assessment, design space, and control strategy. The presentation was given by Dr. Jean-Louis Robert at an ICH-GCG ASEAN conference in Kuala Lumpur, Malaysia, where he discussed these concepts, provided examples, and emphasized building quality into products through a systematic and science-based development approach.
CoreRx, is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
Pilot plant scaleup techniques | unit 1 | Industrial pharmacyFirst name Last name
General considerations-including
significance of personnel requirements, space requirements, raw materials,Pilot plant scale up
considerations for solids, liquid orals, semi solids and relevant documentation,
SUPAC guidelines,Introduction to platform technology
American Peptide Company (APC) is a peptide manufacturing company founded in 1987 that offers catalog peptides, custom peptide synthesis, and cGMP manufacturing of pharmaceutical peptides. APC has expanded its facilities over the years and currently has a headquarters in Sunnyvale, CA and a cGMP manufacturing facility in Vista, CA. APC aims to be the industry leader in peptide process development by providing high quality peptides and services from early research to commercial quantities.
This curriculum vitae summarizes the professional experience of Rajeev Kumar Srivastav. He has over 23 years of experience in quality control roles, primarily in the pharmaceutical industry. He is currently the Head of Quality Control and Microbiology at Aurobindo Pharma Limited. Previously, he has held quality control leadership positions at several major pharmaceutical companies, including Nicholas Piramal India Limited, Unimark Remedies Ltd, and Aurobindo Pharma Limited. He has extensive experience managing quality control teams, implementing quality systems, and preparing for and successfully passing regulatory inspections, including by the US FDA.
Technology Transfer From R and D to Pilot Plant to Plant for Non-Sterile Semi...shiv
Technology transfer is important for successful progress of drug development from research to commercialization. This presentation discusses technology transfer from research and development to pilot plant and full-scale production of non-sterile semisolids. It covers the importance of pilot plants in scale-up, factors to consider in scaling up semisolids like mixing equipment and homogenization processes. SUPAC guidelines for scale-up and post-approval changes are also summarized. A case study demonstrates issues encountered like congealing during scale-up of a cream formulation containing diethylene glycol monoethyl ether from lab to pilot scale.
This document discusses the application of ICH Q8 and Q10 principles to pharmaceutical product development and manufacturing. It begins with an example of a dissolution failure incident to highlight the importance of understanding products and processes. It then outlines tools and approaches like knowledge management and quality risk management that can be used from development through commercial manufacturing following ICH Q8 and Q10 guidelines. Finally, it provides a case study example of how these principles were applied to the development of the drug Saxagliptin.
2. Fierce Ranks Xcelience #2 in 2011 Thanks FiercePharma Manufacturing and Nice Insight! #2 Standout CMO - Xcelience
3. Company History 1997 Established as Tricon 1998 Acquired by Top 6 Global CRO 2008 CEO Finalist for E&Y 2008 Entrepreneur of the Year Tampa Chamber of Commerce Small Business Award Finalist 2006 Xcelience Formed by MBO 2007 Purchased Grace Street for Expansion 2009 Tampa Chamber of Commerce Small Business Award Finalist (2 nd Year) 2010 CEO Cancer Gold Standard Accreditation 2011 3 Stage Facility Expansion
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9. Potent Compounds, Low Dose Formulations Xcelience may handle Pharma 3b and SafeBridge III compounds (30 ng/m 3 ) Roughly 1/3 of Xcelience projects involve potent compounds Pharma 1 2 3(a) 3(b) 4 OEL(µg/M 3 ) >1,000 100 – 1,000 10 – 100 1-10 <1 SafeBridge I II III IV OEL(µg/M 3 ) >500 500-10 10-0.03 <0.03
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