|
In an era characterized by the need to continuously evaluate and bolster R&D pipelines, the increasing complexity and overall cost to develop and approve drug products, the trend toward genericization, and mounting pressures to both decrease prices and maximize profitability, the pharmaceutical industry has sought competitive advantage in lower cost manufacturing jurisdictions.
The Commonwealth of Puerto Rico provides unparalleled value as a location for high quality cost effective ...
|
|
|
|
|
|
|
Capsules are incompatible with some fills. For instance, some for- mulations cause them to dissolve—almost seeming to melt—while others cause cracks to spontaneously form. While both effects stem A from an interaction between the fill and the capsule shell, crack formation requires the additional presence of mechanical stress on the shell. This article describes an investigation into how areas of high mechanical stress in gelatin capsule shells relate to the formation of spontaneous cracks in ...
|
|
|
|
|
|
|
The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies. Although Clinical Supply Management is often considered a back-office business unit for a sponsor, it is almost always on the critical path of the drug development process. The efficient, accurate and timely delivery of material to the investigators is critical for a successful clinical trial. Given that cost plays a key role in the drug development process, ...
|
|
|
|
|
|
|
This article describes an investigation into why gelatin capsule
shells filled with hygroscopic materials sometimes crack. Its conclusions counter important aspects of the traditional theory.
As the popularity of liquid-filled hard capsules (LFHCs)
increases, formulators are becoming more interested in
ways to evaluate the compatibility of their formulations
with the capsule shell, particularly in the pharmaceutical
arena, where it is sometimes necessary to use hygroscopicfill materials ...
|
|
|
|
|
|
|
Common literature methods for determining formalde- hyde in air and water are based on derivatizing formalde- hyde first, by the use of either 2,4-dinitrophenylhydrazine (DNPH) or 2,3,4,5,6-pentafluorobenzyloxyamine (PFBOA) and then quantitating the resulting hydrazone or oxime. We report general procedures for the derivatization and determination of total extractable formaldehyde as well as leachable formaldehyde in hydroxypropyl methylcellulose (HPMC) capsules. Trapped formaldehyde in HPMC ...
|
|
|
|
|
|
|
The formulation of drugs into capsules is often utilized in early phase development due to the relatively quicker formulation-development process. The bioavailability of the poorly soluble drugs can be significantly increased when formulated in a solubilized form in a capsule (i.e. liquid or semi-solid filled capsules). Acidic degradation and dyspeptic side effects associated with some compounds are overcome by enteric coating of the dosage form. This work is an evaluation of the ability of ...
|
|
|
|
|
|
|
Chemical categorization (or banding) of inherent toxicity and potency linked with defined safe work environments including exposure controls has become an integral component of assuring the health and safety of research workers and manufacturing personnel in the pharmaceutical industry but is not a substitute for quantitative risk assessment in the workplace.
|
|
|
|
|
|
|
While “going green” is a recent cliché, it is also a key factor to consider when developing a product or modifying a process. In today's economic climate, the regulated product manufacturer needs to perform a thorough cost-benefits analysis before considering such a change. The obvious benefit of going green is the environmental aspect. However, the potential competitive benefits need to be examined as the first step in this process. The following are potential competitive benefits by going ...
|
|
|
|
|
|
|
It is a universal truth that research, development manufacture and formulation of potent active pharmaceutical ingredients (APIs) and products requires both “hardware” ( facilities, equipment and engineering controls) and “software” (programs, practices and procedures) to adequately protect personnel and the environment. When employing third party contracting organizations, there is a need to evaluate safe processing with the same rigor as other aspects of drug development, such as quality ...
|
|
|
|
|
|
|
Eywiesenstraße 5 88212 Ravensburg Germany
phone: +49-(0)751-3700-0 fax: +49-(0)751-3700-4000 e-mail: info@vetter-pharma.com www.vetter-pharma.com
Know-how Technology Transfer from R&D to Manufacturing
Heston Hall/Carriage House · Suite 203 1790 Yardley-Langhorne Road Vetter Pharma International GmbH Yardley, PA 19067 Ravensburg, Germany USA
phone: +1-215-321-6930 fax: +1-215-321-6932 e-mail: info@vetter-pharma.com www.vetter-pharma.com
|
|
|
|
|
|
|
Dissolution is an important test method that is carried out on solid oral dosage forms like capsules, tablets, and oral suspensions. For these dosage forms to be efficacious, the active drug substance must be absorbed into the systemic circulation so that it can be transported to its site of activity. The overall efficiency of this process contributes to the bioavailability of the drug substance and involves two steps, dissolution and absorption, or permeability, as defined within Food and Drug ...
|
|
|
|
|
|
|
Powder & Porous Materials Characterization
Powder Density in Solid Dosage Forms B by: Martin A. Thomas Ph.D., Director of Business Development Quantachrome Instruments (martin.thomas@quantachrome.com) Both active and inactive (excipient) compounds nal or tapped state. In free-owing powders the are used in the manufacture of solid dosage initial bulk and tapped densities will be more formulations, i.e. tablets and capsules. These similar than in poor owing powders which yield powders possess ...
|
|
|
|
|
|
|
The word biocompatibility refers to the interaction between a medical device and the tissues and physiological systems of the patient treated with the device. An evaluation of biocompatibility is one part of the overall safety assessment of a device. Biocompatibility of devices is investigated using analytical chemistry, in vitro tests, and animal models, in vivo tests. The biocompatibility of a device depends on several factors, including:
the chemical and physical nature of its component ...
|
|
|
|
|
|
|
Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements.
In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory infractions. Among the violations were production records that lacked second-person verifications, ...
|
|
|
|
|
|
|
HighPoint Solutions leads the strategy and integration of a new contracting and pricing system for pharmaceutical manufacturers. Learn how your organization can leverage HighPoint Solutions’ experience and work with the pharmaceutical division to enable clients to jumpstart implementation.
|
|
|
|
|
|
|
DASGIP develops and manufactures technologically advanced Parallel Bioreactor Systems for the cultivation of microbial and mammalian cells at bench top scale. www.dasgip.com
o Parallel operation of 4, 8 or more vessels o Suitable for cell cultivation and microbial fermentation o Control hardware optimized for small scale process development o Hard- and software designed for efficient parallel operation o Results as good as and scalable to large scale runs
Groton Biosystems develops and ...
|
|
|
|
|
|
|
High Containment Milling of Potent Compounds in the Pharmaceutical Industry
by George Tunnicliffe, Managing Director, Kek-Gardner Ltd Martin Thomson, Sales Director, Kek-Gardner Ltd
With the trend towards pharmaceutical products of higher toxicity requiring greater standards of containment, the protection of mill systems against the consequences of a powder explosion are of ever greater importance. The selection of explosion protection method is often made at a late stage in the mill system ...
|
|
|
|
|
|
|
A guideline for those involved in the selection, specification, and purchase of mixers
Mixing is possibly the oldest and most widely used of all technical processes. It is carried out in virtually every in handling or processing powders with other ingredients and there are very few products used in everyday life that have a mixing process as part of their manufacture. Mixing can therefore be considered as one of the essen technological processes. To avoid problems of poorly or unmixed ...
|
|
|
|
|
|
|
Martin Thomson, Sales Director at Kek-Gardner Ltd discusses the practical benefi of a mobile milling system
What are the advantages of a mobile system? Regardless of which industry you may be in, with resources stretched and a potential downturn in customer dema anything that will improve the flexibility of a production facility is welcome. Many traditional mill systems are dedica a single process line. However, a mobile, integrated milling system that can be relocated easily and be interchang ...
|
|
|
|
|
|
How to Insure the Right Finish for Mixers used in High Purity and Sanitary Processes.
Admix Inc. (Manchester, New Hampshire) has extensively used stainless steel alloys to fabricate mixing and blending equipment for the dairy, food, beverage, cosmetic and pharmaceutical industries. Admix recognizes that, in order to meet the high standards of purity and cleanliness demanded by the pharmaceutical and biopharmaceutical industries, it is necessary to use 316 stainless steel as the material of ...
|
|
|
|
|
|
|
The advent of bubble elimination in a prefilled syringe offers many advantages worth exploring prior to deciding how a product is to be packaged for clinical studies or commercial distribution. This technique further enhances the benefits of prefilled syringes. Prefilled syringes vs. vials have become the container of choice for parenteral drug delivery. The increase in their use is directly correlated to changes in the healthcare industry. Some of the main advantages of prefilled syringes are ...
|
|
|
|
|
|
|
To identify bacteria and fungi, pharmaceutical manufactures rely on curated, compliant and up-to-date libraries. Results of using a proprietary library, based on over 300,000 unknown organisms recovered from environmental monitoring programs, show a two-fold reduction in unidentified strains when compared to a commercially available library.
|
|
|
|
|
|
|
BUHLER AEROGLIDE WHITE PAPER: Reducing the Environmental Impact of a Convection Dryer
Global warming, carbon footprint, greenhouse gases; ten years ago, none of us had even heard of these terms, but today, they are on the front page of every newspaper and magazine. You may or may not agree with the science behind global warming, but you cannot ignore the fact that this science will impact how you do business. Many large corporations have adopted environmental policies which commit them to go ...
|
|
|
|
|
|
|
Crystal engineering provides a rational approach to solving formulation, processing and product performance problems. This review discusses how the concept of crystal engineering can be judiciously utilized to manipulate the solid-state properties of
drugs and excipients for successful pharmaceutical formulation and process development.
Existing and emerging manufacturing as well as co-processing technologies being applied in the pharmaceutical industry are also presented together with ...
|
|
|
|
|
|
|
Founded in 1962 and serving many of the world's leading life sciences rms, Tunnell Consulting integrates strategic, technical, process, and organizational skills to design and implement sustainable solutions that exactly meet client needs. With deep industry knowledge, extensive scientic credentials, and superior measurable results, we consistently boost the operating performance of each unique client we serve.
Getting Up to Speed and Staying There Lean Lab Improvement That Lasts
I n order to ...
|
|
|
|
|
|
|
The Micropack III DataTrace system from Mesa Laboratories was found to provide highly accurate temperature measurements for up to one year and longer. By analyzing routine recertification data collected in Mesa's calibration laboratory it was demonstrated that 70% of the temperature data loggers maintained their published accuracy specification of +/- 0.1°C for one year or more, and 99% of the loggers were within +/- 0.5°C over this same time frame.
Based on these data, it is recommended ...
|
|
|
|
|
|
|
Medical Device Manufacturers have always focused on bringing innovative high quality products to market. Yet shifting financial, regulatory and globalization landscapes call for closed-loop product management strategies that can keep up with the increasing innovation tempo and complexity of medical devices while at the same time, lower cost, increase quality, and facilitate compliance with regulatory requirements. Total product lifecycle (TPLC) is aimed at enabling accelerated innovation, ...
|
|
|
|
|
|
|
When it comes to the steam sterilization of liquid media, there are a number of user concerns that are handled in various ways. Monitoring these cycles with biological indicators (BIs) and the various restrictions and cycle modifications that are done can lead to a false positive or failed cycle. Here are only a few of the cycle modifications done or restrictions applied by users for the steam sterilization of liquid media:
- I want to keep the media flask in a container while being ...
|
|
|
|
|
|
|
Close control of the EtO sterilization process is required to ensure the safety of medical devices. Requirements for validation and control of EtO sterilization have increased substantially in recent years. The ANSI/AAMI/ISO (American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization) 11135 standard "Medical devices -- Validation and routine control of ethylene oxide sterilization" was issued in 1994, but due ...
|
|
|
|
|
|
|
“PREMATURE FAILURE OF TIMBER IN COOLING TOWERS;
CAUSES, CHALLENGES AND FUTURE STRATEGIES”
Rajesh Shah, Creation Cooling Towers, 232, G.I.D.C. Industrial Estate, Waghodia – 391 760. URL: http://www.creationhvac.com E-mails: sales@creationhvac.com, creationhvac@yahoo.com as on 25.10.2008
There are two main categories of Wooden Material: 01. Hard Wood 02. Soft Wood
In India, hard wood is not available like Redwood of U.S.A. quality and hence, since long soft wood quality is used in Cooling ...
|
|
|
|
|
|
|
The ability to respond to ever-evolving consumer at- titudes, regulatory mandates, and scientic discov- eries requires that manufacturers keep their nger on the pulse of the analytical methodologies required to monitor product safety and quality. In light of the ever- growing number of food and supplement ingredients and complex formulations, the ability to detect unique com- pounds and quantify levels of ingredients at trace levels presents challenges to researchers. The increased efciency and ...
|
|
|
|
|
|
|
Pre-filled syringes are quickly becoming a viable alternative to vials. Review the benefits they offer, including reduced overfill requirements, decreased waste and enhanced product differentiation.
Prefilled syringes are a fast- growing alternative to vials in the parenteral product market due to the many advantages they offer relative to vials. These include reduced overfill requirements, ease of use, more accurate dosing, decreased waste, and enhanced product differentiation. Conventional ...
|
|
|
|
|
|
|
Process variability is a leading cause in biopharmaceutical batch failure and impacts the value and profitability of the industry. Thermo Fisher Scientific controls inherent variability through the use of the Thermo Scientific Antaris line of Fourier transform near-infrared (FT-NIR) spectrometers.
|
|
|
|
|
|
|
02 Contents 03 Finding the right contract manufacturer 04 The basics 05 The portfolio factor 05 Finances: for the long term 06 Looking at the soft factors 06 The benefits of partnership 07 Working together 07 A partnership for success
Contract manufacturing became popular in many industries during the 1990s as a way to counter rising costs and to reinvestment. The pharmaceutical indus- try has been slow to adopt this practice because of its absolute need for secrecy. However, with fewer ...
|
|
|
|
|
|
|
Calibration, maintenance and validation activity, despite operating within the same department in some organizations, have generally been managed separately, each with their own procedures and their own computerized management systems. Since even calibration and maintenance professionals tend to access records differently and track different types of information, these separate and unconnected systems made sense. However with new regulatory pressures and in search of greater productivity and ...
|
|
|
|
|
|
|
Few companies that manufacture or market personal care products can claim that they have never had a microbiological contamination. We live in a world where microorganisms are ubiquitous and have adapted to every possible environment. They are able to survive in the most hostile and inconceivable environments imaginable. This is what makes the study of microorganisms such an interesting science. Public health risks and potential damage to a product brand name are such important issues that the ...
|
|
|
|
|
|
|
White Paper Regulation 21 CFR Part 210-211
© 2006 Pilgrim Software, Inc. All Rights Reserved
The demand for healthcare products is ever increasing as the landscape of modern society evolves. These trends are reshaping the Pharmaceutical and Biologics industries. With the demand for products, comes the concern among pharma-bio manufacturers for regulatory scrutiny. Non-compliance is fiscally damaging and potentially life-threatening, both to a manufacturer and its customers. Warnings, fines ...
|
|
|
|
|
|
|
Equipment qualification is a
necessary and critical step in
ensuring that a product or service
is provided accurately and
consistently with requirements
aligned with medical device
manufacturing and testing. This is
especially critical for the medical
device industry because the
medical device manufactured by a
company is considered a piece of equipment and requires qualification, as much as other
equipment and instruments involved in manufacturing. Verifying prerequisites before
qualification ...
|
|
|
|
|
|
|
The identification of fungi, especially filamentous fungi, has historically been a very difficult task. Due to the amount of experience required to accurately identify filamentous fungi to the species level, it has become acceptable to either identify these organisms to the genus level, or in some cases, simply identify them as “molds.” Over the years, there have been numerous attempts to automate biochemical tests. Since eukaryotic organisms exhibit far less metabolic diversity than ...
|
|
|
|
|
|
|
Robert J Broeze is the President and Chief Executive Officer of Laureate Pharma. He has over 20 years of experience in the biopharmaceutical industry, with technical expertise spanning research, development, characterisation, validation and current Good Manufacturing Process (cGMP) manufacture of biopharmaceutical products, from pilot to phase III clinical and commercial scale with a strong emphasis on monoclonal antibody products for parenteral use. Prior to joining Laureate, Dr Broeze held ...
|
|
|
|
|
|
|
The Food, Drug and Cosmetic Act requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. A sponsor however will want to ship an investigational drug to clinical investigators in many states; it must seek an exemption from that legal requirement. The Investigational New Drug Application (IND) obtains this exemption from the Food & Drug Administration (FDA). FDA's role in the development of a new drug begins when the ...
|
|
|
|
|
|
|
The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices and components utilized in the manufacturing of the product. Packaging includes components such as vials, caps and stoppers. Drug delivery devices include nebulizers, syringes, medical devices and various types of inhalers. Components utilized during the product manufacturing process include filters, tubing, fittings, connectors, ...
|
|
|
|
|
|
|
How to Guide for Writing a Drug Master File Introduction A drug master file (DMF) is a proprietary document typically written by or for the manufacturer to protect manufacturing information, an intermediate, starting raw material, Active Pharmaceutical Ingredient (API), description of production site/s or for other special requests. Most often, DMF's are written to protect the manufacturing information of an intermediate or API. However, many countries require a Site Master File (SMF). ...
|
|
|
|
|
|
|
With critical new prescription drugs introduced annually, an effective new product launch strategy is essential to gain market acceptance and quickly build market share. Successful pre-launch planning should be all- encompassing, addressing a product’s distribution channels, forecasting, product availability and allocation strategy, sales and marketing planning, sales force training, visibility into the launch effectiveness and more. This pre-launch phase typically relies on limited comparative ...
|
|
|
|
|
|
|
FDA Accredited Persons Third-Party Inspection Program (TPI) To ensure that appropriate medical device manufacturing conditions and controls are in place, the U.S. Food, Drug and Cosmetic Act established a requirement that the FDA inspect manufacturers of Class II and III Medical Devices at least once every two years. Due to limited resources and significant growth of the Medical Device Industry, the FDA has difficulty meeting this demand.
The need for additional inspection resources has ...
|
|
|
|
|
|
|
Single-use, disposable products were first introduced to the biomanufacturing industry about a decade ago. Until recently, single-use manufacturers had to extol their benefits and virtues to convince biomanufacturers to consider trying them. However, today’s growing biopharmaceutical product diversity, increasing demand, and high development costs are forcing an increasing number of life sciences companies to incorporate single-use, disposable technologies into their biomanufacturing
production ...
|
|
|
|
|
|
|
For companies performing photostability testing in accordance with ICH guideline Q1B, Caron’s 6540 series chambers overcome the challenges of lamp selection, light control and other chamber design issues. By integrating technical requirements with practical solutions, Caron’s Photostability Chambers enhance the testing process to ensure product quality and regulatory compliance.
|
|
|
|
|
|
|
Development and manufacturing of recombinant-protein–based vaccines has in the past few years become very similar to that of other well-documented and well-characterized biological drugs. For investigational vaccines, chemistry, manufacturing, and controls (CMC) information is critical for a successful regulatory filing. The process development and CGMP manufacturing of a recombinant protein drug is on the critical path toward clinical phase 1 dosing and safety studies as well as ...
|
|
|
|
|
|
|
The voluntary certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products in the global market.
In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Device Directive, Medical Device Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with ...
|
|
|
|
|
|
|
The highly publicized withdrawal of a number of unsafe drugs from the market over the last several years has led to strong criticism of FDA's ability to protect the public health, resulting in a call for fundamental changes in the United States drug safety system. A report commissioned by FDA in the wake of the Vioxx® withdrawal, and subsequently issued by the Institute of Medicine in 2006, concluded that the science of drug safety needed major improvements. Recommendations included a ...
|
|
|
|
|
|
|
When the Occupational Safety and Health Administration (OSHA) enacted the Hazard Communication Standard (HCS) in 1983, the chemical manufacturing and distribution industries were the most affected by the broad sword of complying with the regulations. At the heart of this standard, is the idea that all employees have a right to know what the chemicals and associated hazards are in their workplace.
To that end, chemical manufacturers and importers must convey both physical hazards (such as ...
|
|
|
|
|
|
|
Considerations When Selecting Temperature Sensors
Modern pharmaceutical/biotechnology research and drug/medical product manufacturing organisations, face increasing costs in their endeavours to produce a market winner. Driven by the opposing needs of meeting the profit expectations of the shareholders and the seemingly continuing demands of the various regulatory bodies.
Recent years have seen many of the smaller organisations swallowed up by their larger competitors followed by many of the ...
|
|
|
|
|
|
|
Patheon is a global provider of contract development and manufacturing services to pharmaceutical and biotechnology industries worldwide. They employ over 4,700 skilled staff at 10 locations in the United States, Canada, and Europe.
Over the years, Patheon had grown quickly through the relentless acquisition of manufacturing sites from pharmaceutical companies or other contract manufacturing companies. However, this type of growth often brings with it an inconsistent consumer experience for ...
|
|
|
|
|
|
|
Drug innovators, collaborators, licensing partners and the myriad of third parties who handle active pharmaceutical ingredients (APIs) need to take notice when the APIs they are handling have the following properties – clinical doses less than 10 milligrams causing pharmacological or toxic effects in patients or if low doses (less than 1 mg/kg/day) in laboratory animals may potentially be “-genic” (i.e, they are mutagenic, teratogenic, carcinogenic or are reproductive or developmental ...
|
|
|
|
|
|
|
Knowledge is power. When it comes to choosing your suppliers for buying instruments, equipment or services, are you effectively utilizing maintenance and service information to help you make wise purchasing decisions? Do you know how well your suppliers are performing? Do you know how your manufacturers and service providers compare to each other in quality and service delivery? Do you have the tools and information to help you leverage the volume of your purchasing power and negotiate better ...
|
|
|
|
|
|
|
A major global pharmaceutical manufacturer projected that a recently acquired manufacturing site for biologicals production and packaging would never become profitable under existing start-up plans. But they were reluctant to resort to a CMO located far from the product's largest market. So the company chose Tunnell to determine if the cost-base at the site could be sufficiently reduced to justify putting the plant into commercial operation.
The result: A combination of process improvements ...
|
|
|
|
|
|
|
Drug manufacturers must verify the identity of their incoming raw materials prior to release into the production process. For some, meeting this requirement involves extracting and testing samples from a small fraction of their incoming containers; for others it means testing every single package. Regardless, all find thorough and compliant material identity verification a costly exercise, with costs that span operational, personnel, facility planning, capital equipment, maintenance and ...
|
|
|
|
|
|
|
NuAire products manufactured from Polypropylene materials require special consideration for the care and use to assure maximum customer satisfaction. Polypropylene materials have many favorable characteristics, such as being resistant to many chemicals, rigid, durable, and available in many thicknesses. NuAire fabricates the Polypropylene materials in many different ways to produce a variety of products for the laboratory. Understanding about the care and use of the Polypropylene material is ...
|
|
|
|
|
|
|
Quality in the Global Pharmaceutical Supply Chain
Quality in the Global Pharmaceutical Supply Chain
Supplier quality has been a prime topic at recent industry conferences. Original Equipment Manu- facturers (OEM) material suppliers and contract manufacturers attended to listen to the implica- tions and driving forces behind the scrutiny of our supply chain. Although regulations and guidelines are already in place in multiple industries, supply chain complexity has grown from simple domes- tic ...
|
|
|
|
|
|
|
Pharmaceutical contracting has transitioned over the past 20 years from being a small, incremental part of pharmaceutical manufacturers’ business to one that is integral to almost every market segment. Contract strategy and effectiveness is now a key differentiator in the Managed Markets space to increase profitability.
In many cases, the sale of an individual unit to the end patient results in the need for manufacturers to honor multiple contractual agreements. For instance, sales within the ...
|
|
|
|
|
|
|
Under the principle of caveat emptor, the buyer takes the
responsibility for the condition of the items or quality of the services that he or
she purchases. Prior to the current consumer protection laws, buyers had no
warranties for the goods or services that they purchased. Today, most states
require goods to be of “merchantable or sellable quality”. As this condition is
often next to impossible to define and enforce, buyers are advised to embrace the
principle of caveat emptor prior to ...
|
|
|
|
|
|
|
Demand-planning practices for clinical supply chains aren’t healthy. Despite the prevalence of such basic demand-planning
practices, there are some companies that have developed
more sophisticated, stochastic demand-modeling
and simulation capabilities. Robust simulation and modeling of clinical trial site enrollment, coupled with efficient manufacturing of
clinical supplies and execution of protocols, can save
life sciences companies millions of dollars in new
product development costs. ...
|
|
|
|
|
|
|
The current financial crisis, increasing global competition, and near patent expiry of several multibillion dollar drugs is fundamentally reshaping the pharmaceutical industry. As consolidation in the industry continues through merger and acquisitions, companies are being forced to examine new strategies to cut costs and improve efficiencies to adapt to new financial realities. To that end, pharmaceutical companies have begun to outsource greater percentages of their drug development and ...
|
|
|
|
|
|
|
Since the USP General Chapter <467> on Residual Solvents became effective on July 1, 2008, Lancaster Laboratories has seen a multitude of requests for many different solvent and sample matrix combinations. The new General Chapter applies to both monographed and non-monographed items, including all drug substances, excipients, and products “subject to relevant
controls.” So a number of manufacturers have turned to Lancaster Laboratories for assistance.
|
|
|
|
|
|
|
NuAire products manufactured from Acrylic materials require special consideration for the care and use to assure maximum customer satisfaction. Acrylic materials have many favorable characteristics, such as being lightweight, rigid, durable and available in many colors as well as clear. NuAire fabricates the acrylic materials in many different ways to produce a variety of products for the laboratory. Understanding about the care and use of the acrylic material is important.
|
|
|
|
|
|
|
Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and costeffective.
Part 1 of Running a Marathon in Flip-Flops addressed the value of incorporating prerequisites into process validation using ...
|
|
|
|
|
|
|
Trade directors at branded pharmaceutical manufacturers are challenged by the tendency for retail pharmacy chains to supply their distribution centers through wholesalers. Without accurate and timely sales data, trade directors often nd it difcult to fully understand the impact of their indirect chain customers. Furthermore, this group’s (chains, mass merchandisers and grocers) position as the largest class of trade – representing more than 44% of total Rx sales – mandates the development of an ...
|
|
|
|
|
|
|
EV Battery Pack Testing in a Manufacturing Environment
Electric vehicles are clearly becoming a growing part of the automotive scene. They promise low or no emissions, conceivably low cost of fuel from the power grid, yet they will continue to deliver us safely from here to there. However, electric vehicle design and manufacturing is a clearly a paradigm shift for the Auto Industry – new drive systems, technologies… and test plans.
Electric vehicles are bringing new test and validation ...
|
|
|
|
|
|
|
V E T T E R C A S E S T U D Y : V E T T E R C A S E S T U D Y | 2 S P E E D I N G U P T I M E T O M A R K E T
In the hyper-competitive pharmaceuticals and biotechnology markets, companies face a litany of challenges, from stricter regulatory guidelines and rising develop- ment costs to the pressures of globaliza- tion. To succeed under these conditions, pharmaceuticals and biotech firms are finding it critical to reduce their time to market, thus creating competitive advan- tage and maximizing ...
|
|
|
|
|
|
|
On March 21, 2010, the EC Directive 2007/47/EC will become effective. This Directive will have a big impact on the Directives 90/385/EEC and 93/42/EEC. All manufacturers declaring conformity of their products to either of these EC Directives should be aware of the following: Medical devices according to 90/385/EEC or 93/42/EEC must also comply with the new EC Directive starting March 21, 2010 , other- wise the products cannot be placed on the European market.
Clear requirements so far ...
|
|
|
|
|
|
|
There are often problems implementing conventional methods of controlling particulate exposures during many pharmaceutical manufacturing processes. Pharmaceutical manufacturing processes tend to be less flexible than similar chemical manufacturing processes due to the high level of regulation within the industry (i.e., Food and Drug Administration (FDA)). In addition, because the products are designed to be biologically active, exposure limits are often very low (a few micrograms or even ...
|
|
|
|
|
|
|
Actril Cold Sterilant is an US EPA registered disinfectant that has a broad range of disinfection claims. Actril Cold Steril- ant is used in a wide range of healthcare and clean room facilities. This technical white paper examines the use of Actril Cold Sterilant in a pharmaceutical manufacturing en- vironment that complies with USP-NF <1072>: Disinfectants and Antiseptics.
Actril Cold Sterilant is a ready to use peracetic acid and hy- drogen peroxide based liquid disinfectant that has been ...
|
|
|
|
|
|
|
The FDA rule relating to the use of Electronic Records and Electronic Signatures (21 CFR Part 11) is one of the most significant pieces of new legislation to affect the pharmaceutical manufacturing industry in recent times.
With ever greater use of information technology and computer systems at all stages of manufacture, more and more of the operating processes are being automated. As a result, key decisions and actions are being taken through electronic interfaces, with regulatory records ...
|
|
|
|
|
|
|
The purpose of this white paper is to document and summarize the current status of the regulatory requirements set forth by different agencies like FDA (in US), ICH (in Europe), and that of Japan and China. In the first section of the paper we will provide the background information on the role of FDA, the regulatory agency in the USA, and the current state of cGMP “risk based approach” enforced by the FDA, which focuses on an integrated approach of good science and good engineering practices ...
|
|
|
|
|
|
|
What is the best way to measure rancidity in my sample? That is an often asked and simple question that, unfortunately, belies a simple answer. Many factors must be considered when selecting the most appropriate test or series of tests, and it is often difficult to predict which method will yield the most meaningful results.
What Causes Rancidity? Fats and oils play an important role in the flavor, aroma, texture, and nutritional quality of foods, pet foods, and feeds. Fats and oils may be ...
|
|
|
|
|
|
|
Careful planning, innovative machine design, and rigorous attention to detail will assure maximum product delivery and minimize timelines from project initiation to completion. By the time a parenteral product arrives at our facility for filling, a client has invested considerable time and significant resources in its development and manufacture. Our experiences clearly demonstrate the importance of planning and attention to detail for achieving a filling run that enables that product to move ...
|
|
|
|
|
|
|
Their Effect on Pharmaceutical Autoclave Chamber/Load Probes
An often ignored consequence of using longer than average lead wire lengths for pharmaceutical autoclave chamber probes, is the sacrificing of accurate temperature measurement. When planning to upgrade or purchase an autoclave incorporating temperature probes with longer than average conductors it is therefore essential to give this factor due consideration.
Detector Types and Construction PT100 detectors are now available in two ...
|
|
|
|
|
|
|
Sales and Marketing Compliance in the Pharmaceutical Industry A Focus on Sales Strategy and Operations
With the increasing involvement of Federal and State Governments in sales, marketing and promotional activities, it is critical that organizations properly implement compliance procedures and closely monitor sales and marketing activities to mitigate compliance risks in order to avoid sizeable fines and violations.
At a high level, compliance must exert control over sales, marketing and ...
|
|
|
|
|
|
|
The purpose of this paper is to discuss the application of Raman spectroscopy to the unique requirements of raw material testing. In order to do so we will answer the following questions:
1. What is and why perform identity testing? 2. What are the incentives to speed up testing? 3. Should we consider modifying the testing process? 4. How does the Thermo Scientific TruScan handheld Raman instrument perform ID testing? 5. How well does TruScan® work for common raw materials? 6. Can this be ...
|
|
|
|
|
|
|
Concern regarding extractables and leachables has been increasing over the past few years, as evidenced by regulatory guidance documents [1-3]. One means of qualifying a component as being suitable for use in a drug product is to determine the extraction profile of that component in multiple solvents with polarities similar to and bracketing that of the product vehicle. Any observed extractables can then be identified and potential leachable concentrations assessed by a toxicologist to ...
|
|
|
|
|
|
|
Transforming A Customer Base Into A Fan Base
World Cat is an award-winning manufacturer of power catamarans, twin-hulled watercraft that are quick and streamlined, yet stable enough to safely navigate even the roughest seas. Boaters and fishermen from around the world have embraced this design as the preferred hull for navigating and fishing some of the wildest water in the world.
In the boating world, catamarans are very much a niche market, and it can be difficult to reach potential ...
|
|
|
|
|
|
|
AdvantageMS Selected for Best Address Pilot
Fort Washington, PA: AdvantageMS is pleased to announce that it's Best of Breed (BOB) address for Providers has been selected as the most accurate as compared to competitive offerings in a pilot conducted by a top 10 Pharmaceutical Manufacturer.
Top data quality issues encountered by our clients:
· Provider addresses: 37% inaccurate · Deceased Status: 7% of clients “active” are in fact deceased · Retired Status: 4% of client's active are in ...
|
|
|
|
|
|
|
In the manufacture of potent active pharmaceutical ingredients (APIs) and products, there is a need to conduct qualitative and/or quantitative healthbased risk assessments for both occupational and product (patient) safety purposes. When performed from an occupational standpoint, qualitative health-based risk assessments involve the categorization (“banding”) of the API based on toxicity and potency, which provides a measure of relative hazard. Each occupational health categorization is then ...
|
|
|
|
|
|
|
A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas or gamma or electron beam radiation. The sterilization process must be validated for each product to verify that it effectively and reliably kills any organisms that may be present on the pre-sterilized product. By means of the cGMP medical device regulations, FDA has established some of ...
|
|
|
|
|
|
|
REMOVAL OF WHITE SILICONE POWDER FROM REUSABLE GLASS PIPETTES
The problem of white powder on glass pipettes is caused by the over-heating of the silicone pads during dry-heat sterilization cycles. The decomposition temperature for the silicone formulation is 550°F (288°C). As the pads undergo decomposition, they will deposit a white powdery film on the inside of the can and on the surfaces of the pipettes. The film has little effect on most applications and is inert to most chemicals. The ...
|
|
|
|
|
|
|
Pharmaceutical and biotech companies of all sizes are increasingly turning to third parties to execute some or all of their clinical supply activities. There is a need for these companies to control and track these activities in their information systems.
This article addresses the various methods in which the activities of third-party supply contractors and IVRS (Interactive Voice Response System) providers can be integrated into these systems.
The Clinical Supply Organizations (CSO) in ...
|
|
|
|
|
|
|
Aptuit Informatics 29219 Canwood Street, Suite 120 Agoura Hills, CA 91301 USA Tel: +1 818.879.0075 Fax: +1 818.879.7303
Information contained herein is proprietary to Aptuit Informatics, Inc. Ideas, concepts, designs, methods and the like are the intellectual property of Aptuit Informatics, Inc. and as such are protected by US and international copyright laws as well as US and international laws governing the protection of and trade in intellectual properties. This document may not be ...
|
|
|
|
|
|
|
A sensitive radioimmunoassay (RIA) method was validated for the determination of octreotide in male rat plasma using reagents provided in the kits by Peninsula Laboratories, Inc. (Belmont, CA). The components provided in the RIA kit were used to validate octreotide in male rat plasma over a concentration range of 80-1280 pg/mL.
Octreotide mimics the action of somatostatin, a naturally occurring hormone found in the brain and gastrointestinal tract. Somatostatin is one of several substances ...
|
|
|
|
|
|
|
The FDA is currently reviewing the 510(k) regulations. The current regulations are designed to assure the safety and effectiveness of medical devices. These regulations govern various aspects of the design, clinical evaluation (where required), manufacturing, packaging, labeling (including promotional information), commercial distribution, and post-market surveillance of medical devices. In a memo from 2009, the former (as of March 26, 2010) Director of the Office of Device Evaluation at FDA, ...
|
|
|
|
|
|
|
Three-phase partitioning (TPP) represents an incredibly simple, rapid method for extracting, purifying and concentrating proteins for use as either a protein mini-prep kit or scaled up to large manufacturing operations. Three-phase partitioning (TPP) is a relatively new, three-stage, batch method for rapidly and effectively purifying proteins (1,2). The TPP method may be used as a protein mini-prep kit (3) or scaled up to large manufacturing operations (2). The method employs high ...
|
|
|
|
|
|
|
For companies performing photostability testing in accordance with ICH guideline Q1B, CARON's 6540 series chambers overcome the challenges of lamp selection, light control, and other chamber design issues. By integrating technical requirements with practical solutions, CARON's Phoot stability Chambers enhance the testing process to ensure product quality and regulatory compliance.
ICH Q1B guideline is the harmonized effort to standardize photostability testing on new pharmaceutical drug ...
|
|
|
|
|
|
|
Unifying materials, even though they are aimed at notably different buyers, yield significant impact on the perceptions both segments have about the size, scope and sophistication of BASi. The more modern and progressive visual presenta- tion has helped position them among the leaders in their markets.
“BASi had aggressive plans for growth that we believed simply could not be met without reevaluating our marketing. SCORR came in with a very reasoned approach, beginning with detailed research ...
|
|
|
|
|
|
|
Part 2 Why Products Get Contaminated and What To Do About It.
Part 1 of this article discussed basic microbiology related to the manufacturing plant environment and consumer product formulations. Part 2 will discuss what to do when a finished product contamination occurs, and suggest how to investigate and track the problem. The article will also provide some tips on how to come to a final resolution when a contamination has occurred.
There are numerous ways that product contamination may be ...
|
|
|
|
|
|
|
|
